ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for default Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.
Eisai Company Ltd (PK)

Eisai Company Ltd (PK) (ESALY)

61.51
0.00
(0.00%)
Closed May 15 4:00PM

Empower your portfolio: Real-time discussions and actionable trading ideas.

ESALY News

Official News Only

ESALY Discussion

View Posts
IPO$ IPO$ 1 year ago
Big new now. Alzheimer’s number one enemy.
👍️0
whytestocks whytestocks 4 years ago
News: $ESALY Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

- Agreement Extends to Additional Potential Indications for Filgotinib, Including Ulcerative Colitis, Crohn's Disease and Psoriatic Arthritis - TOKYO, Dec 24, 2019 - (JCN Newswire) - Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences ...

Got this from ESALY - Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval
👍️0
mrplmer mrplmer 4 years ago
Eisai need to dump the relationship with Biogen and the aducamab pig license Anavex 2-73 for Alz, PDD and Rett. Harold Hampel knows the potential in the billions
👍️0
whytestocks whytestocks 4 years ago
News: $ESALY Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer's Disease Using Blood

- Presenting the Most Recent Data at the 12th Clinical Trials on Alzheimer's Disease (CTAD) Conference - TOKYO, Dec 9, 2019 - (JCN Newswire) - Sysmex Corporation and Eisai Co., Ltd. are pursuing a joint project to develop a method of diagnosing Alzheimer's disease (AD) using blood, presented...

Find out more ESALY - Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer's Disease Using Blood
👍️0
whytestocks whytestocks 4 years ago
News: $ESALY Eisai Satisfies All-Case Surveillance Condition for Approval of Anti-Cancer Agent Lenvima in Treatment of Thyroid Cancer

TOKYO, Dec 9, 2019 - (JCN Newswire) - Eisai Co., Ltd. has received a notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) to the effect that the "all-case surveillance" special drug use-results survey condition required for approval of the orally available kinase inhibitor ...

Find out more ESALY - Eisai Satisfies All-Case Surveillance Condition for Approval of Anti-Cancer Agent Lenvima in Treatment of Thyroid Cancer
👍️0
whytestocks whytestocks 4 years ago
News: $ESALY Eisai to Present Latest Data on Alzheimer's Disease / Dementia Pipeline at 12th Clinical Trials on Alzheimer's Disease Conference

TOKYO, Dec 2, 2019 - (JCN Newswire) - Eisai Co., Ltd. announced today that three oral presentations and eight poster presentations, highlighting the latest data on its Alzheimer's disease / dementia pipeline including anti-amyloid beta (Abeta) protofibril antibody BAN2401, orexin receptor anta...

In case you are interested ESALY - Eisai to Present Latest Data on Alzheimer's Disease / Dementia Pipeline at 12th Clinical Trials on Alzheimer's Disease Conference
👍️0
whytestocks whytestocks 4 years ago
News: $ESALY Eisai: Additional Indication for Lenvima (Lenvatinib) for Differentiated Thyroid Cancer Accepted in China

TOKYO, Dec 2, 2019 - (JCN Newswire) - Eisai Co., Ltd. has announced that LENVIMA (generic name: lenvatinib), the orally available kinase inhibitor discovered by Eisai, has been accepted by the National Medical Products Administration of China for an application for the additional indication of...

In case you are interested ESALY - Eisai: Additional Indication for Lenvima (Lenvatinib) for Differentiated Thyroid Cancer Accepted in China
👍️0
whytestocks whytestocks 5 years ago
News: $ESALY "Science Based Targets (SBT) Initiative" Approves Eisai's Greenhouse Gas Reduction Targets

TOKYO, May 17, 2019 - (JCN Newswire) - Eisai Co., Ltd. announced today that Eisai has received approval from "Science Based Targets (SBT) Initiative" for Eisai's mid and long-term targets for greenhouse gas (GHG) reduction. "SBT Initiative" is an international joint initiative by CDP which i...

In case you are interested https://marketwirenews.com/news-releases/-science-based-targets-sbt-initiative-approves-eisai-s-greenhouse-gas-reduction-targets-8203630.html
👍️0
mick mick 6 years ago
Eisai Co., Ltd. (PC) (ESALY)
56.88 ? 0.115 (0.20%)
Volume: 649 @ 4:00:02 PM EST ET
Bid Ask Day's Range
56.68 57.24 56.88 - 56.88
ESALY Detailed Quote
👍️0
mick mick 7 years ago
Eisai Co., Ltd. (PC) (ESALY)
53.585 ? 0.0 (0.00%)
Volume: 0 @- ET
Bid Ask Day's Range
52.83 54.3 - - -
ESALY Detailed Quote
👍️0
buzz lightyear buzz lightyear 11 years ago
All Eyes Awaiting Arena Prescription Numbers
Aug 15 2013, 12:51 | by Spencer Osborne | about:ARNA
include:VVUS
The tug-of-war in the stock price of Arena Pharmaceuticals (ARNA) continues this week. The price movement shows the appearance of a run getting ready to start, but the bears then seem to step in and bring the equity back down. The biggest difference in the past week or so is that Arena is now seeing the battleground take place in the $7's rather than the $6's. The next catalyst for Arena happens tomorrow when the prescription numbers from IMS Health are released in the morning, followed by the Symphony Health numbers later in the afternoon. Savvy investors will be placing their proverbial bets today. Make no mistake, this is an active equity with near term action playing on the volatility that Arena offers.

Meanwhile, long term investors are betting on the potential of not only the weight loss drug Belviq, but the other indications that Belviq could treat, as well as the Arena pipeline. The chart below illustrates both IMS (orange) and Symphony (green) numbers vs. a model tracking to $150 in gross sales (BLUE) and analyst expectations that would deliver $10 million in "royalty" revenue (percentage of the net sales) to Arena. At $10 million in "royalty revenue some analysts carry a $12 price target on Arena.

(click to enlarge)


While there has been much debate about IMS numbers vs. Symphony numbers, the two are tracking in the exact same area. In fact, the difference between the two numbers, when adjusted, equates to about 5 days of scripts. Thus far, sales of Belviq have been good but not great. They have shown traction, but are not rocketing upward. Simply stated, this is a process that will not happen overnight. This is especially true given the dynamics at play when we look at the weight-loss space:

Prescription weight-loss drugs still contend with the fen-phen fiasco because the drug was promptly removed from the market due to heart issues
Insurance companies are still hesitant to cover anti-obesity drugs. This dynamic is changing, but will take time
The cost of treatment, especially for uninsured can be daunting, at least in perception, to many people
It takes time to get doctors on board and educate them about the benefits of the drug.
As yet there is no direct to consumer advertising
It takes time to get enough people with good results to begin a more organic word-of-mouth movement.
Tech Investor
Seeking Alpha
The chart depicted above shows results through last week. Whether you prefer IMS numbers or Symphony matters little. As stated, they are in the same vicinity in terms of sales traction and trending. What moves the needle on Arena when it comes to sales figures is IMS Health numbers. They come out first and the market reacts. Symphony numbers can track about 6 hours later, after the moves have already played out. This past week Symphony numbers did not come out until Monday, three days after IMS.

As stated, neither the IMS or Symphony numbers are illustrating a blistering pace. They are however tracking above the level of sales that would, in theory, give Arena a $12 price target. For long term holders that represents a more than 50% increase from current equity prices. That is not a bad return, even for the more active near term trader.

The interesting dynamic here is that we are only a 4 to 6 weeks away from being able to extrapolate sales to a point where the potential exists that near term and long term investors goals may align. If that happens, equity appreciation may not be far behind. If the trend line demonstrates that the sales will get to levels deserving of a higher price target, the tug-of-war may fade away.

Specific to tomorrows numbers, we want to see the sales come in high enough to remain above the yellow analysts line, at a minimum, and preferably remaining above the blue $150 million dollar line (gross sales). For comparison, the analyst line tracks to about $70 million in gross sales.

If IMS numbers come in at about 3,500 it will represent growth, but not offer anything very compelling to shift the stock price upward in reaction. To see a swing upward in reaction it would take an IMS number of 4,000 or more. In my opinion, we will not see that happen yet. Essentially we are now approaching the time where patients will begin to arrive at the 12 week decision point of whether or not Belviq works for them. Those that respond to the drug would, in theory, remain on it. Those that do not respond will come off. What we want to see is enough growth in new patients to not only offset the churn of non-responders, but also demonstrate positive growth overall.

Competitor Vivus (VVUS), with its drug Qsymia, has shown a choppy path in sales. This is attributable to many factors, one of which is patient churn. It creates flat spots in the growth curve of Qsymia sales. What near term traders are looking for is whether flat spots develop in Belviq sales. If sales appear to flatten out, the active traders will rule the day once again. If the sales show continued growth, the philosophy of the buy-and-holders will gain strength.

IMS numbers should be out by mid-morning on Friday. Be ready, because it is getting interesting. Stay Tuned.

Disclosure: I am long ARNA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
👍️0
buzz lightyear buzz lightyear 11 years ago
Arena Approaches 50% Institutional Ownership
Aug 15 2013, 12:08 | by Spencer Osborne | about:ARNA
includes:OREX, VVUS
Arena Pharmaceuticals (ARNA) is approaching 50% institutional ownership. The company currently sits just below the magic number at 49% according to data recently updated by Nasdaq, and through June 30th of this year. Because the data is trailing, the company could already be over the 50% mark. We will not know that for a few more months.
👍️0
buzz lightyear buzz lightyear 11 years ago
Needs a defibrillator , clear!!! ZAPP
CLEAR!!! ZZZAAAPPP
👍️0
buzz lightyear buzz lightyear 11 years ago
News for 'ESALY' - (Eisai Announces Availability of Halaven(R) (eribulin) in Kuwait)


HATFIELD, England, Jul 28, 2013 (PR Newswire Europe via COMTEX) -- HATFIELD,
England, July 29, 2013 /PRNewswire/ --

Partnership deal secured with Yiaco for Kuwait distribution

Eisai EMEA (Europe, the Middle East, Africa, Russia and Oceania) today announces
its partnership with Kuwait's leading pharmaceutical marketing agency, Yiaco
Medical Company, for the distribution of Halaven(R) (eribulin), for the
treatment of patients with locally advanced or metastatic breast cancer, who
have progressed after at least two chemotherapeutic regimens for advanced
disease.

Commenting on the availability of eribulin in Kuwait, Toshitaka Asano, Vice
President Market Development Business Unit EMEA, said: "The distribution of
Halaven in Kuwait is part of Eisai's wider strategy of establishing a solid
foundation in the EMEA region. We recognise Kuwait as a strong and stable market
in the region which has a rapidly growing population with very specific
healthcare needs. Our valued partnership with Yiaco Medical Company will mean
people can receive rapid access to innovative treatments not previously
available to them."

Kuwait is recognised as one of the best-regulated pharmaceutical markets of the
Gulf Cooperation Council (GCC) and remains the second most attractive
pharmaceutical market in the region according to the latest Business Monitor
International (BMI) Risk / Reward Ratings (RRR) analysis.[1] Continued market
growth is anticipated over the next five years, buoyed up by both a high birth
rate and an expanding population, offering the industry a relatively stable
environment in which to operate.[1]

"As the market-leading pharmaceutical distributor in Kuwait, we are excited
about the opportunity to work in partnership with Eisai to distribute Halaven in
this region," said Tareq Alryan, Assistant CEO, Pharma and Business Development,
at Yiaco Medical Company. "Our unrivalled market knowledge and reputation in the
region allows us to support Eisai in launching Halaven in Kuwait, whilst at the
same time addressing the health needs of patients and their families in Kuwait."

Eribulin is now commercially available in Kuwait and received the full
registration in October 2012.

As part of Eisai's globalisation strategy set out in its mid-term strategic plan
in 2011 "HAYABUSA", the company seeks to expand its global presence by 2015 in
an effort to achieve its objective of making contributions to more than 500
million patients worldwide. Since its launch in the European Union in March
2011, eribulin is now widely available worldwide.

ENDS

Notes to Editors

About Eisai's Commitment to Improving Global Access to Medicines

Today, it is estimated that some 2.7 billion* people around the world live on
US$ 2 or less per day. Most of these 2.7 billion people do not have access to
essential health care and treatment despite the availability of effective
medicines. This is an international challenge that needs to be solved through
collaborations among governments, international organisations such as the WHO,
non-governmental organisations and pharmaceutical companies.

In line with its human health care (hhc) mission, Eisai is committed to
improving global access to medicines over the medium-to-long term through
partnership strategies that involve working with governments, international
organisations, private entities and non-profit organisations. Specifically, the
company has developed and is implementing a five-target approach to improve
access to medicines worldwide. The five key components are: product creations,
strategic solutions, capacity building, quality innovation, and long-term
investment.

For further information on Eisai's Access to Medicines initiatives, please visit
the Access to Medicines page on the Eisai Global
website:http://www.eisai.com/company/atm/index.html

* Source: World Bank (2005)

About Eisai

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and we define our corporate mission as "giving first
thought to patients and their families and to increasing the benefits health
care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:



- Oncology including: anticancer therapies; tumour regression, tumour

suppression, antibodies, etc

- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss

- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid

arthritis, psoriasis, and inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan,
Eisai employs more than 10,000 people worldwide. From its Knowledge Centre in
Hatfield, UK, Eisai has recently expanded its business operations to include
Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales
and marketing operations in over 20 markets, including the United Kingdom,
France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark,
Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium,
the Middle East and Russia.

For further information please visit: http://www.eisai.co.uk

About Yiaco

Yiaco Medical Company was established in the year 1953 as a sole marketing agent
for many multinational research-based pharmaceutical manufacturers. Yiaco
quickly grew with the boom in Kuwait's own national growth and development,
diversifying and expanding into other healthcare services such as Medical
Equipment, Hospital supplies and Dental equipment & materials. Through its many
years of operation and experience in the medical field, Yiaco's reputation of
excellence precedes its name. A name that has come to mean undisputed market
leadership in the area of medical care, unparalleled sales and services, as well
as innovative state-of-the-art technology for the medical and healthcare fields.

Yiaco is fully committed to the modern healthcare system in Kuwait and abroad;
and through this commitment, it has earned the privilege of delivering
intelligent and economic solutions to the medical profession and the public.
This commitment is not only evident through its ability to equip entire
hospitals and research centers from the ground up, but in its solid financial
holdings and a proud family of employees.

1. Business Monitor International: Industry Risk / Reward Ratings - Kuwait - Q2,
2013



Date of preparation: July 2013

Job Code: Halaven-UK0146


CONTACT: CONTACT: Media Enquiries: Eisai Europe Ltd, Cressida Robson / CharlotteAndrews,

+44(0)7908 314 155 / +44(0)7947 231 513,Cressida_Robson@eisai.net,

Charlotte_Andrews@eisai.net ; Tonic LifeCommunications, Siobhan Reilly / April

Kenneally, +44(0)207 798 9999 / +44(0) 207 798 9263, siobhan.reilly@toniclc.com

, april.kenneally@toniclc.com; For further information on Yiaco Medical Company

in Kuwait, pleasecontact: Tareq Alryan - Assistant CEO, Pharma and Business

Development,Yiaco , +965 222 460 31, agm@yiacokuwait.com. For further

information onYiaco Medical Company in Kuwait, please contact: Tareq Alryan -

AssistantCEO, Pharma and Business Development, Yiaco,

+965-222-460-31,agm@yiacokuwait.com




Copyright (C) 2013 PR Newswire Europe

-0-




SUBJECT CODE: PDT

Topic

BIO

Topic

HEA

Topic

MTC

Topic

United Kingdom

Iran

Iraq

Israel

Jordan

Kuwait

Lebanon

Saudi Arabia

Syria

Bahrain

Palestine

Qatar

Yemen

Oman

United Arab Emirates
👍️0
buzz lightyear buzz lightyear 11 years ago
we can read all of the reports and opinions
until the end of time, but i truly believe one
of the big pharma's are going to buy -arna-/
-esaly- out. they are not going to let these
little companies get all the profit from this
class of drug market. they are going to bite
the bullet and give up. they will not risk the
chance on the other potential players
👍️0
buzz lightyear buzz lightyear 11 years ago
9:06 AM Belviq (ARNA) script data for the week ending July 19: 2,840, +14% W/W. Shares -1.14% premarket. Read comments
👍️0
buzz lightyear buzz lightyear 11 years ago
News for 'ESALY' - (*DJ Mylan Sued By Eisai, Novartis Over ANDA For Rufinamid >MYL)
👍️0
buzz lightyear buzz lightyear 11 years ago
Arena Inks Belviq Deal For Taiwan
Jul 25 2013, 13:37 | by Spencer Osborne | about: ARNA
Arena Pharmaceuticals (ARNA) announced today that the company has signed a deal with CY Biotech for marketing and distribution of the anti-obesity drug Belviq in Taiwan. Belviq is not yet approved for Taiwan, but clearly the companies intend to get the application process rolling in the near term.

Arena will manufacture Belviq at its facility in Switzerland, and sell the finished product to CYB for a purchase price at 45% of CYB's annual net sales. As part of the deal Arena received an upfront payment of $2 million, and is eligible to receive purchase price adjustment payments based on CYB's annual net sales, as well as a milestone payment upon approval of the first additional indication for Belviq by the Taiwan FDA. CYB will be responsible for the development, regulatory approval and, ultimately, marketing and distribution of Belviq in Taiwan, including related costs and expenses.

The percentage of NET sales at 45% is noticeably higher than the sliding scale in the deal between Arena and Eisai for marketing the drug in the Americas. One likely reason is that Eisai (ESALY.PK) is paying a substantial portion for a lot of ongoing and future studies relating to Belviq. If the deal with CYB is structured similarly to the Eisai deal, Arena will receive the greater of a guaranteed minimum per pill or the 45% of the net sales. Net sales remove discounts, spoilage, rebates, shipping, etc. from the gross sales figure.

Arena indicated in its press release that half of Taiwanese men and 33% of women are overweight or obese. This makes Taiwan a leaner nation than the United States, which has about 66% of the population in the overweight or obese category. Nearly 85% of the Taiwanese population is in the age category for taking Belviq.

The population of Taiwan is about 23.3 million, with that number split evenly between men and women. With about 20 million adults, the potential market would include about 5 million men and 3.3 million women. While the market is not substantial, every bit helps. I do not expect this deal to be a stock driver in the near term, but do feel that it adds incremental value, especially when weighed with the other deals and approvals that will be coming in the near future.

There has been no indication as to a time-frame for gaining approval. The company has partnered with Ildong in Korea, and has applications pending in Canada, Mexico, Switzerland, and Brazil with some countries working in cooperation with others. The application in Europe was withdrawn so that the company could answer regulatory agency questions. A new submission date in Europe has not been established.

Arena will be conducting its Q2 conference call on August 1st. It is anticipated that this will offer the company's first impressions on Belviq sales in the United States.
👍️0
buzz lightyear buzz lightyear 11 years ago
Analysts And Arena Pharmaceuticals
Jul 21 2013, 12:36 | by Spencer Osborne | about:ARNA
include:VVUS
If you are invested in Arena Pharmaceuticals (ARNA) you are likely aware of the long road it took to get the anti-obesity drug Belviq to the market. You are also are likely aware of the high expectations that the anti-obesity space had after the FDA approved Belviq and Vivus' (VVUS) Qsymia last summer.

Qsymia was first to market but hampered by REMS restrictions. The drug had a slow launch and disappointed the street as well as investors. Ultimately activist shareholder First Manhattan led a proxy fight to sieze control of the board and management of Vivus. That proxy battle was resolved last week.

With Qsymia seeing a slow launch, investors were not quite sure what type of expectations to place on Arena's Belviq. Talk of blockbuster status ($1 billion of sales in 1 year) evaporated last Fall. Analysts built models, but there were not many clues as to how well a prescription anti-obesity drug would fare with doctors, patients, and insurance companies.

In mid May of 2013 Arena marketing partner Eisai outlined at a shareholder conference that it was anticipating Belviq sales to be $200 million by March 31st of 2014 (the fiscal year end for Eisai). I covered that projection at the time, while in many circles it flew under the radar. That $200 million figure was a much more substantial than what analysts had projected. This left investors pondering whether to believe the company that was going to be responsible for launching and marketing Belviq (Eisai), or the analysts that cover the sector.

Three weeks after the $200 million figure was discussed by Eisai's CEO, and on the day Belviq launched, Eisai executive Lionel Coates appeared on national television and stated that "We are hoping to do $150 million this year" (Eisais Coates On 2013 sales Of Arena's Anti-Obesity Drug). Subsequent to the $150 million announcement, Jack Lief, CEO of Arena stated at the annual shareholder meeting that the $150 million was conservative.

After the launch of Belviq, the timing of the $150 million became a topic of debate. Many long term investors that were excited about the prospects of $150 million in sales by December suddenly began to take a stance that the $150 million figure was actually meant for March 31st of 2014, and not December 31st of this year. That debate continues to this day. In order to believe that the $150 million outlined by Coates is March 31st you must consider the following and find it plausible:

Mid-May 2013 - Eisai CEO (Global) informs his investors that the sales goal for Belviq was $200 million by March 31st.
Three weeks later an Eisai America CEO appears on national television and states that the sales goal is $150 million.
Arena CEO states that the $150 million is conservative.
Is it likely that the CEO of Eisai would guide Eisai investors to $200 million and then in the subsequent three weeks trim that number by 25%?
Is it likely that Coates went out on his own undercutting his CEO by trimming the goal by 25%?
Is it likely that a highly anticipated drug launch would have its goal trimmed by 25% without a single analyst or a single headline regarding the subject?
Readers can arrive at their own opinions on the subject. Personally I believe that the $150 million was referring to this year. I believe that undercutting the CEO's stated goals at a shareholder meeting is not in the company culture of Eisai. It is for this reason that I track the weekly scripts against $150 million in gross sales by the end of the year.

With all of that being said, I get a lot of emails that essentially say that tracking prescription sales to a company's stated goal is not being fair to the company. I happen to disagree. I think that a company's stated goal is of great importance even if it is not offered as official guidance. I also believe that a lot of debate and speculation could be retired if Arena or Eisai issued some form of guidance.

What I am seeing now is a lot of requests from investors that want to see the weekly prescriptions compared to analyst expectations, which are much lower, than to company stated goals. I suspect that the main reason that long term investors want to see this comparison instead is because the launch of Belviq, while positive, has not been setting any records. There are many reasons for this. They include getting doctors up to speed, a lack of insurance coverage, and the fact that anti-obesity drugs are considered expensive by many.

Two analyst firms that cover Arena most closely are Jefferies and Leerink Swan. Both actually carry similar $12 price targets and similar sales goals. What I am seeing most often are investors quoting that expectations are about $34 million in sales in 2013. What most investors are missing is that the $12 price target is not based on sales, but rather the anticipated $10 million in revenue that Jefferies and Leering Swan are anticipating that Arena will receive.

These analysts built their models prior to the launch, and prior to the realization that Eisai was going to offer substantial discounts immediately. One discount is for a free $15 day trial (a wholesale cost of $100). The other is a $75 per month rebate. If you take a moment to consider the price target on Arena, it is based on Arena seeing about $10 million in royalty revenue. With the discounts in play, it will take more prescription sales to deliver the same $10 million.

Arena will receive 31.5% of the NET revenue. Items like discounts, shipping, etc. all come out of the Gross Revenue to derive NET revenue. If we consider that NET Revenue on prescriptions is about $125, it will take 272,000 prescriptions by the end of the year to get there. Essentially, if 272,000 prescriptions sell, analysts see the equity at a fail value of $12 per share. I have added an analysts line to my tracking below. The analyst model is graphed in yellow. The gray line models to the 750,000 prescriptions that will be needed to reach $150 million. The blue line represents a second model to 750,000 prescriptions. The orange line illustrates the current pace using channel check numbers that I adjust upward by 30%.

(click to enlarge)


As you can see in the graph, the current sales pace is above the blue hockey stick model as well as the analysts model. Current sales are tracking well below the more straight line path to 750,000 prescriptions.

In the Jefferies analysis there are two additional targets. The downside scenario places a price target of $3 if Belviq sales have limited traction. The Jefferies upside has a price target of $33 if Belviq sales show a "much faster launch trajectory than they assume as a monotherapy through 2014." The revenue Jefferies projects for 2014 is about $27 million. Investors can assign their own assumption to what "much faster" is, but it would likely be at least double what Jefferies is modeling.

What we have in the first 5 weeks of launch is a pace is slightly above the base Jefferies and Leerink Swan models. I think it is fair to state that this is not a "much faster trajectory. The yellow analyst line is tracking to $54 million in sales by the end of 2013. Current Belviq sales are trending in that range or slightly higher (on a straight line basis). If the sales begin to gain exponential traction, and we see a hockey stick take shape, the sales, and thus revenue to Arena, will increase.

Some important factors investors need to consider:

I assigned NET Revenue per script a $125 value. If that value is lower, more prescriptions will need to sell and the Arena share per script will be less. If it is higher, then less prescriptions will be needed to derive the revenue.
Current sales pace (though early) is on target to justify the analysts $12 price target or slightly higher.
Current sales pace will not achieve the $150 million by year end unless the hockey stick forms. With advertising not happening until December or January that will be more difficult.
Getting more insurance companies to cover ant-obesity drugs will be a compelling motivator to increase sales as well as improve the bottom line. The discounting is happening because of a lack of insurance coverage.
To see a higher price target and upgrades Gross Sales will need to get upwards of $70 million (assuming that the 31.5% split is based on $125 NET)
Eisai getting to its own sales goals carries importance. Missing $150 million can happen by a pretty wide margin and $12 is still a safe target. If sales can top $100 million it will boost the 2014 models and deliver some much higher price targets ($25 or better)
Advertising should start by December of this year. That can ramp things substantially. The wrench in those works is insurance. Advertising translate into sales much better if Insurance is covering.
Eisai has a goal of 40% insurance coverage by the end of the year. It is currently estimated to be between 30% and 35%. If Insurance can get to 50% and beyond savvy investors will see the opportunity before analysts report it.
Summary

There are many things to look at and track with this equity. Tracking overall sales, NET sales, prescription numbers, insurance coverage, and street expectations all mean that the homework required by investors can be extensive. This drug, equity, and sector all have potential, but it is too soon to determine how much potential there is. As quarters pass the fundamental story will gain importance as well. Stay tuned.

Disclosure: I am long ARNA. I have no position in Vivus (VVUS). I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
👍️0
buzz lightyear buzz lightyear 11 years ago
Lose 3-4 lbs per week with new FDA approved weight loss medication: Belviq. At http://www.loseweightwithbelviq.com"; endocrinologist and weight loss expert Dr Richard Lipman outlines all of the advantages of this exciting new weight loss medication. Belviq works directly on the appetite centers of the brain sending messages though out the brain that you are full and to stop eating.Belviq is the first new prescription drug for weight loss in the pass 20 years. Belviq was released by the FDA in early June 2013. It offers a new alternative for weight loss for the nearly one in three Americans who are considered obese. It is very effective in diabetics causing both weight loss and improvement in glucose control. Unlike any other diet medication it's designed both for weight loss and weight maintenance.As a weight loss pill, Belviq-is utterly ground breaking, primarily because of its amazing two-pronged action: eliminating appetite or craving, as well as helping diabetics improve their glucose control. This is crucial because many overweight individuals also suffer from diabetes, and Belviq manages to slay the two-headed monster in one stroke of the proverbial sword.For weight loss purposes, Belviq works by keeping us feeling as if we've just eaten, with none of the usual side-effects that plagued previous other weight loss pills.

How does Belviq work?
The drug works by controlling appetite — specifically by activating brain receptors for serotonin, a neurotransmitter that triggers feelings of satiety and satisfaction. Serotonin is also involved in mood; many antidepressant drugs work by preventing the reuptake of serotonin and keeping brain receptors bathed in the chemical. Researchers at Arena say their drug is designed to seek out only the serotonin receptors that affect appetite.

How effective is Belviq?
According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting weight — or an average of 12 lbs. — over a year, compared with 23% of those taking a placebo. For best results, dieters are advised to use the medication together with a healthy diet and exercise program
Who can take Belviq?

The FDA approved the medication for people who are obese (with a body mass index, or BMI, of 30 or higher) or who are overweight (with a BMI of 27 or above) and also have at least one weight-related health condition such as type 2 diabetes, hypertension and high blood lipids and cholesterol.

Are there any side effects?
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation. These side effects occurred in 6% or less patients and most disappeared after a few days. Only 6% of subjects pulled out of the Belviq studies because of side effect. In patients with diabetes, side effects include low blood sugar, headache, back pain, cough and fatigue.
👍️0
buzz lightyear buzz lightyear 11 years ago
don't worry, be patient. i truly believe this
investment will pay-off.
it is { common sense } telling me, that one of
these big pharmas' are going to let these two companies
make all the money in { obesity.} they have spent
billions on { r&d } over the years trying to enter
that market.
👍️0
buzz lightyear buzz lightyear 11 years ago
Before saying anything else, I need to point out that it is still quite early in the game. Often success or failure of a drug, when it comes to Wall Street, is not whether or not it actually helps people, but rather whether or not it is selling strongly enough to help the bottom line. If you are invested in Arena (ARNA), it is sometimes more prudent to separate your passion for the product from your thought process about Arena as an investment. While 5 weeks of sales does not determine the long term, it is enough to begin to extrapolate the general trajectory. Arena is down about 3% in pre-market trading based on prescription numbers for the week of July 12, 2013.

As Arena and Eisai (ESALF.PK) launched Belviq they spoke to $150 million in sales. Right now that is the only company sourced "guidance" that really exists for investors to consider. With that in mind I have identified that 750,000 scripts need to be sold to attain that goal. I modeled two distinct paths to get to that point. One is a more straight line path, and the other is what we call a hockey stick trajectory. As I chart the weekly data it is important for the adjusted sales to be above at least one of these paths to have a viable chance of getting to the desired goal of $150 million in sales.

Prescription data comes primarily from two sources. IMS Health and Symphony Health both tabulate and extrapolate sales estimates. Neither offers an exact figure. In my model I use IMS data because it tends to hit the street first. Symphony data tends to report slightly higher than IMS. I apply a 30% adjustment to IMS data and a 20% adjustment to Symphony. These adjustments account for things like pharmacies that do not share data or scripts that are written for multiple months.

The IMS sales data for the week of July 12th on Arena's anti-obesity drug Belviq was 2,493. My adjusted total for the week is 3,241. Belviq sales are tracking just above the hockey stick model in my chart. The straight line model that I outlined for reaching $150 million by December 31st is likely not a path that will happen at this point, putting greater importance on the actual sales trend staying at or above the hockey stick model. That means that as each week passes we will need to see exponential growth ramping up.



(Click to enlarge)

While it may be difficult to see, the orange line that represents actual sales is tracking just on top of the hockey stick path. The pace of the Arena launch may not be as fast as many had hoped for, but it is still showing a possible path to $150 million in sales in 30 weeks.

One reason that this week's prescription numbers might appear weaker than some anticipated is that "churn" is now starting to come into play. Churn would essentially be a patient that bought a prescription and is now at the point of whether or not to refill it. Patients that do not respond to the drug, finances, or any number of factors could result in a patient dropping off of a prescription. Essentially at this point, and moving forward, drop-outs come into play.

One comparison that investors in the sector may want to look at is how the Belviq launch compares to the launch of a competitor. Vivus (VVUS) makes and distributes the anti-obesity drug Qsymia. Qsymia had a very poor launch and has never seen a hockey stick model develop. Instead it has taken a more paced and traditional stepped approach. You can see that Belviq is outpacing Qsymia each week. A few notable items are that when Qsymia launched Belviq was not on the market yet, and that early Qsymia numbers were sold at full price. Qsymia did not offer discounts until week 12. Belviq had discounts upon launch.



(Click to enlarge)

In summary, the sales launch of Belviq is maintaining traction. The drug is not setting any records, and will continue to be sensitive to the perception of the street. It will take compelling moves in weekly script data to silence its critics. What we seem to have here is a pace that is high enough to demonstrate hope and potential, but not high enough to remove fear and doubt. At the moment Arena remains in a range that favors active swing traders playing on the perception of the moment. Long term there is potential here. Many factors, such as insurance coverage, are gaining more importance as it appears that the drug alone, regardless of price, is not generating immediate buzz just yet. Bear in mind that things can change quickly. Stay Tuned.

Disclosure: I am long ARNA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. I have no position in Vivus
👍️0
buzz lightyear buzz lightyear 11 years ago
they are separating their subs. for a reason
👍️0
buzz lightyear buzz lightyear 11 years ago
Esaly spinning off it's agricultural side. IMO to become better looking to PFE if they are meeting.
Notice Regarding Transfer of Shares of Eisai Subsidiary 07/19 06:21 AM

Tokyo, July 19, 2013 - (JCN Newswire) - Eisai Co., Ltd. (ESALF:$42.75,00$2.50,006.21%) today entered into a share transfer agreement with Lawson, Inc. ("Lawson") concerning the transfer of all shares held by Eisai (ESALF:$42.75,00$2.50,006.21%) (70% of total shares issued) in its consolidated subsidiary Eisai Seikaken Co., Ltd. ("Eisai Seikaken") to Lawson. 1. Reasons for the Transfer of Shares Eisai Seikaken is a consolidated subsidiary of Eisai (ESALF:$42.75,00$2.50,006.21%) and is engaged in the manufacture and sales of soil fertilizers and similar products; soil and crop analysis; and research and development, manufacture and sales of soil conditioners, plant mineral supplements and other crop nutrition products. Its predecessor company, K.K. Seikaken, was established by Todomu Nakashima in 1967. Since its establishment, Eisai Seikaken has consistently been dedicated to the production of safe, delicious fruits and vegetables founded on "the creation of healthy soil based on diagnostic soil analysis." Specifically, it has made active efforts based on "Nakashima Farming Method" technologies in the cultivation of new production farms for vegetable and fruit tree plantation as well as brand expansion. In doing so, it has developed into a business with a wide presence in ensuring agricultural produce that is delicious, safe for consumption and high in health value. Eisai (ESALF:$42.75,00$2.50,006.21%) believes that the share transfer proposed by Lawson, a company that is entering the agricultural industry by establishing Lawson Farm agricultural companies, will strengthen the "Nakashima Farming Method" brand and increase recognition through active utilization of Lawson infrastructure, and expects that the agreement will lead to sustainable growth and further expansion of Eisai Seikaken. For these reasons, Eisai (ESALF:$42.75,00$2.50,006.21%) decided to transfer to Lawson all shares it currently holds in Eisai Seikaken. Following the transfer, Eisai (ESALF:$42.75,00$2.50,006.21%) will further allocate management resources to other businesses that focus on its pharmaceutical products, and will strive to increase corporate value by speeding up innovation. 2. Outline of Subsidiary to Be Transferred 1) Trade Name: Eisai Seikaken Co., Ltd. 2) Address: Toriko Industrial Park, 312-4, Toriko, Nishihara-mura, Aso-gun, Kumamoto 3) Representatives: Daichi Nakashima, Chairman Yutaka Kusaki, President 4) Scope of Business: Manufacture and sales of soil fertilizers and similar products; soil and crop analysis; research and development, manufacture and sales of soil conditioners, plant mineral supplements and other crop nutrition products 5) Capital: 50 million yen 6) Date Established: July 31, 1967 7) Financial Results for Most Recent Fiscal Year (Fiscal Year Ended March 31, 2013): Sales: 1,476 million yen Total Assets: 2,530 million yen Net Assets: 2,007 million yen 8) Major Shareholders and Ratio of Shares Held: Eisai Co., Ltd. (ESALF:$42.75,00$2.50,006.21%) : 70% Other Shareholders: 30% 9) Number of Employees: 76 (as of March 31, 2013) 10) Major Business Sites: Headquarters: Toriko Industrial Park, 312-4, Toriko, Nishihara-mura, Aso-gun, Kumamoto Sales Office: 6F, NBF Urawa Bldg., 2-5, Higashi-Takasago-cho, Urawa-ku, Saitama-shi, Saitama 11) Total Number of Shares Issued: 5,000 shares 3. Outline of the Purchaser 1) Trade Name: Lawson, Inc. 2) Address: East Tower, Gate City Ohsaki, 11-2, Osaki 1-chome, Shinagawa-ku, Tokyo 3) Representative: Takeshi Niinami, Representative Director & CEO 4) Scope of Business: Franchise chain development of Lawson stores 5) Date Established: April 15, 1975 6) Operating Regions: All 47 prefectures of Japan (11, 275 stores nationwide), China (Shanghai, Chongqing, Dalian), Indonesia, Hawaii, Thailand 7) Relationship with Eisai Co., Ltd. (ESALF:$42.75,00$2.50,006.21%) : No human or capital relationship 4. Change in Eisai's (ESALF:$42.75,00$2.50,006.21%) Shareholding 1) Number of Shares Held Prior to Transfer: 3,500 shares (shareholding ratio: 70%) 2) Number of Shares to Be Transferred: 3,500 shares 3) Number Shares Held After Transfer: 0 shares (shareholding ratio: 0%) 5. Schedule for Stock Transfer July 19, 2013 Signing of Share Transfer Agreement August 30, 2013 (tentative) Transfer of Stock 6. Business Outlook This transaction will have only a minor impact on the Eisai Group's consolidated financial performance. About Eisai (ESALF:$42.75,00$2.50,006.21%)
👍️0
buzz lightyear buzz lightyear 11 years ago
Can Arena's Belviq Prescription Sales Growth Continue At 54% Per Week?
Jul 18 2013, 7:43 | by Reasonable Risk | about:ARNA
include:ESALY.PK
Bearish investors of Arena (ARNA) argue that its new antiobesity drug Belviq failed to explode into an empty niche awaiting new antiobesity drugs and can tell that after a few weeks of sales it is a failure. Bulls argue that we have insufficient data to assess the situation. I also argue that the most recent weeks showing 24%-52% growth (343% since the first week) indicates bears expect too much. At the current growth rate and a meager $150 per script, we can expect more than $1 Billion in sales after a year.

Furthermore, we are not correctly analyzing the situation and ignoring simply human behavior that will explain why growth is not even greater. Here I attempt to deduce answers that might otherwise remain hidden and unpredicted until quarterly reports. It may take months before we can realistically estimate annual sales for Belviq, but we can examine its potential and the problems Eisai (ESALY.PK) currently faces marketing it. Whatever problems Belviq faces, Arena seems to be paying the full price since Eisai is up about 11% whereas Arena is down 19% since Belviq's launch.



(Click to enlarge)

Belviq Scripts Growth Is Greater Than Commonly Believed

When results fail to meet expectations, I seek fundamental flaws in my assumptions. When the Street sunk Arena 9% following the second week of prescription data, analysts, pundits and investors thought scripts failed to grow. I discovered they erred by miscalculating how scripts are generated by emphasizing pharmacies over doctors. While my analysis failed to lift Arena's shares back to where they may belong, future investors may use my method to prevent the market from similarly trashing companies releasing new drugs.

Symphony Health Solutions claims their prescription database is our nation's best. It captures 82% of the weekly activity whereas IMS captures 73%. It is my understanding that much of the missed data is due to chains like Wal-Mart (WMT) that do not sell script data to third parties.

Like my prior analysis, I adjust the data to better estimate the actual number of prescriptions. Contrary to claims by TheStreet.com's Senior Biotech Correspondent, my adjustments do not falsely portray the data. Percent growth remains unaffected by the adjustment since all data is treated the same as children learn when they are taught math.

Over Fourth of July holiday, many pharmacies remained open whereas doctors took vacations. I assign five doctor workdays per week except for the holiday week that I assign three workdays. My results show that doctors wrote 53% more Belviq prescriptions per day during the holiday week than they did the previous week (see figure and table below).



(Click to enlarge)



(Click to enlarge)

Possibilities for Why The Number of Initial Scripts Were Less Than Predicted?

I previously suggested multiple scenarios for Belviq and suggested a low initial rate of prescriptions might be about 30,000 prescriptions per month based on 75% of the doctors contacted by sales reps prescribing Belviq to two patients in the first month. We currently sit at about 10,322 scripts for the month. Since we have 10 Federal holidays per year, the average month has about 20.8 doctor workdays (excluding other absences). We currently have data for 18 days and we will have 23 days when Symphony releases its data on July 19.

I should have expected fewer scripts since the doctors I contacted were generally unaware of Belviq and Qsymia. Arena also warned investors that Eisai planned a slow rollout to ensure doctors select proper patients. I also attribute the difference between results and expectations to a few major factors that should disappear with time.

Doctor-Patient Limitations

Doctors face patients who schedule appointments weeks in advance for various ailments and before doctors were detailed by sales reps. Even if visits obliquely concern obesity, doctors are unlikely to prescribe two drugs that may have overlapping effects when they want to see the effects of Belviq by itself. If investors are lucky, doctors wrote two scripts and told patients to wait a month before trying Belviq. Other doctors may have been treating patients wanting Belviq but currently finishing a cycle of medicine.

Doctors also have bad habits that may be difficult to change absent repeat visits from sales reps. Forty-four percent of Canadian doctors did not even consider antiobesity drugs when treating obesity and most of the prescriptions issued (39%) were because patients requested a drug.

Public Perceptions

Few potential patients are sufficiently aware of Belviq or Qsymia to visit doctors and ask for them. Social media may eventually increase awareness. It may also help counter negative press (e.g., Consumer Reports, discussed here and here; also see the Huffington Post). Yet, I suspect just a tiny fraction of potential patients are aware of the significant weight loss and antidiabetic benefits that await responders. This is in part due to the spam and disinformation from authors and commentators who refuse to acknowledge that in the real world doctors will discontinue non-responders (patients losing less than 5% of their weight in the first 12 weeks) so that only "responders" will remain for longer periods. Thus, the average real-world patient on Belviq after 12 weeks differs significantly from the average trial-patient (the average of both trial responders and trial non-responders who may or may not have completed the trials).

Sales Rep Limitations

If sales reps give pitches similar to those of doctors during the Belviq launch webcast on July 10, it is no wonder why we did not see 30,000 scripts in the first month. It was very informative discussion, but it focused on the average trial-weight loss instead of responder weight loss. We are in the real world now and no longer doing research. Thus, they should have mentioned the meta-analysis showing how an estimated 36% to 50% of real-world patients on Belviq for a year (responders) may lose more than 10% of their weight depending on whether they are diabetic or not. If we cannot get researchers to mention the strongest data, it will take considerably more time before doctors get enough feedback from patients to realize they are underestimating Belviq's potential.

Pharmaceutical Sales Life Cycle Shows Belviq Has Yet To Enter Its Growth Phase

Since weekly scripts are up 340% since the first week, I am reluctant to expect more. Instead, we may see single-digit weekly growth in coming months. We can also expect episodic events resulting in good and bad weeks. The bad weeks may be temporary since Belviq is in the "introduction" phase of growth according to Tata Consultancy Services (see figure below). However, investors must be aware that for some drugs, sales fall flat or they are withdrawn before they get to the growth phase.



(Click to enlarge)

Belviq is a Fundamentally Strong Drug

Since my multifactor comparison of Belviq and Vivus' (VVUS) Qsymia little has changed. Patients can now purchase Qsymia in some stores. Qsymia has also benefited from media coverage of Belviq's launch. I do not believe this will alter Belviq's competitive advantage for the reasons stated in my article and because doctors are still time-limited and must still deal with Qsymia's REMS.

Belviq will be doctor's drug of choice due to its safety profile, mild side effects, and excellent efficacy (for those who respond to it). While not marketed as an antidiabetic drug, it has anti-diabetic properties that help both prediabetic and diabetic patients reduce their reliance on antidiabetic drugs that are harmful and may even cause cancer. Thus, we may find that doctors will chose to leave patients on Belviq even if they lose minimal amounts of weight as long as it reduces patient reliance on insulin and DPP-IV drugs.

Conclusion

Scripts are growing by 24% to 83% per week, most recently by 54%. At that rate, sales of Belviq will exceed $1 Billion at $150 per script. I do not expect that, yet I also did not expect good results would trash Arena's shares on false and misleading misinformation experts should have known. Yet, not one analysts announced that the selloff was unjustified was based on erroneous analysis. Perhaps the selloff had nothing to do with the scripts.

Bearish investors are wrong to believe that a lack of direct competition means Belviq and Qsymia will never occupy that empty niche. Yet it will only happen if we remove the disinformation rampant in the media.

Furthermore, until there are advertisements, few members of the public will be aware of new antiobesity drugs or seek them. Thus, most of the scripts were probably from doctors visited by sales reps. Since Eisai still has many doctors to visit, we should expect prescription rates to increase for some time. I think we can safely expect 3,000 scripts written for the week ending July 12.

In the meantime, Arena trades near its 1-year low leaving new investors with far more upside than downside potential. Only time will tell.

Disclosure: I am long ARNA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
👍️0
buzz lightyear buzz lightyear 11 years ago
<data:blog.pageTitle/> - Sierra World Equity Review
sierraworldequityreview.blogspot.com/...eisai-deputy.html
... ( PFE) HQ in NYC ... headquarters in New York City today. Sierra World Equity Review ... and honor Eisai's agreement with Arena Pharmaceuticals.
Sierra World Equity Review : July 2012
sierraworldequityreview.blogspot.com/2012_07_01_archive.html
Also Sierra World Equity Review ventures that Eisai and ... ( PFE) and Arena Pharmaceuticals ( ARNA) ... in New York City today. Sierra World Equity Review ...
👍️0
buzz lightyear buzz lightyear 11 years ago
Go esaly go
👍️0
buzz lightyear buzz lightyear 11 years ago
From ARNA board. BELVIQ SUCCESS STORIES / PATIENT TESTIMONIALS


THIS IS NOT AN OFFICIAL WEBSITE. IT IS NOT OWNED, OPERATED, AUTHORIZED BY ARENA PHARMA (NASDAQ:ARNA) OR EISAI. SEE IMPORTANT PRESCRIBING AND SAFETY INFORMATION ON www.BELVIQ.com. CONTENTS OF THIS DOCUMENT ARE *NOT* MEDICAL ADVICE AND ARE *NOT* INVESTMENT ADVICE. CONSULT WITH YOUR DOCTOR FOR ANY AND ALL MEDICAL ADVICE. THESE ARE PUBLIC STATEMENTS SOMETIMES MADE BY ANONYMOUS PERSONS. OWNER OF THIS WEBSITE CAN NOT GUARANTEE THEIR AUTHENTICITY. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.


PATIENT TESTIMONIALS
As noted above the authenticity of many of these is not known.



9 days 8 pounds
Picked up my new script for B today at CVS. My insurance company picked up a certain amount and Eisai savings card picked up a certain amount. Based on the card and my coverage I ended up with a $50 copay. No matter, $50 is still a great price when it has allowed me to lose a lot of weight already and halve my insulin usage. I am very happy with my results so far. It looks like it will be $600 a year. However I am saving ALOT of money on insulin and another IMAO I was taking. So all in all I am about breaking even
--------------------------------------------------------------------------------

First week results: dropped 5.5 pounds - no side effects

Dropped 5 1/2 pounds. Side effects: none! Simply do not feel particularly hungry - eat because some food is necessary to keep body healthy. Definitely will go on regular prescription. Dr. waiting for results at end of week 2. Sure he will then recommend BELVIQ to other patients.


“A MIRACLE DRUG” : Doctor’s two weeks personal experience with Belviq

I am the ophthalmologist from Dearborn mi. who started taking Belviq two weeks ago.So far I have gone from 242lbs. to 234lbs. for a net loss of 8 lbs. I am eating about half of what I was eating with way less carbs. Further my insulin needs are about one third of what they were before Belviq.. I have no food cravings as I had before Belviq. MY SUGAR LEVELS HAVE IMPROVED TO NORMAL LEVELS FOR A NON DIABETIC.This is truly a life saving drug and a godsend. This truly a miracle drug, I will report my progress in another two weeks.By the way my office staff has noticed my weight loss and six of them who were very overweight insisted on going on Belviq. So I wrote them scripts.


--------------------------------------------------------------------------------

LOST 20 POUNDS

I was part of one of the initial FDA trials of lorcaserin, now on the market as Belviq. I lost 20% of my weight with no additional exercise because I am a "responder". This drug makes my urges to eat and hunger something I can control. I was normal weight for most of my life but started steadily gaining weight after my last of 4 kids were born when I was in my mid-30's. I testified at the FDA panel last year to urge them to allow those of us for whom this drug is very effective to have access....

... This drug works almost immediately so it makes sense for folks to try it with their physician to see if they are also a responder. I got my prescription and have started back on the drug and it works just as I remembered. I hope to lose all of my excess weight in about a year or so but expect to be on it for life, which is preferable to getting sick from being overweight and having to take medicine to treat diabetes or high blood pressure.


--------------------------------------------------------------------------------


My experience on Belviq

received my rx on 14th. my pharmacy did not have it in, and had to go out of town, vac in omaha. on fri 15th called walmart and cvs, did not have it in, called walgreens, and picked it up 20 min later.

I quit craving food,no more fridge raids. half as much at each meal. as of 24th I had lost 11.5 lbs and 4 belt loops. my pot belly is shrinking amazingly. a 2x fits now instead of 3x.

I have never felt this well in 20 years. and I have not really increased working out. but I am very much more active.

I will be getting my first rx for 30 days today. the coupon will pay my copay.


bottom line, it works, no or minimal side effects.
I keep losing, not hungry anymore, and fill after a few bites at a meal.
I need a new belt already. 4 loops in 2 weeks. stomach keeps shrinking. Before I would go to the fridge all day and snack, and never feel full at meals. it is incredible. I feel 20 years younger and alot more active. all within 2 weeks.



Just stopped by my doc's office 14.5 lbs lost since 14th of June [posted Jul 1]


feel great. never hungry. eat alot less to get the full feeling now. not exercising any more, too hot, but i am more active, as I feel so great.
he just said "wow" and he could not believe it when I showed him by belt... told him how never hungry, no more grazing and eat less at meals he asked about side affects and such, and told him how I always felt sated.


Day 4 on Belviq - seems like a responder, but waiting to see. . . .
Family member has been eating roughly 1000 -1200 kcal/day; noticeably reduced appetite. No side effects reported (despite excessive heat, and a BART strike).
. . . .


My Wife
My wife, who besides being perfect, is a typical overweight middle aged woman with children. She's lost 5 lbs in the past 13 days on Belviq. Frankly, she's thrilled.


my progress
I started on friday (the 15). wasnt sure i was gonna, because on vac in omaha. but did it anyway. same thing I do not eat snacks, and eat alot less when I do eat. 2 belt loops lost in just those 4 days. even my family noticed already. I never have the craving to eat. feel great.

Now 4 belt loops smaller. And still no cravings for food. It is amazing. Can't wait to go to dr office to see how much I have lost. Will let you all know. 10 days on it now.

as of yesterday, lost 11 lbs in 10 days. no more craving food. and eat less at meals



The beginning of my Belviq program.
I recently returned from the UK on a 21 day vacation. I had gained from 238 lbs to 246. I am now back down to 237 lbs and will begin BELVIQ today to reduce back to my goal wt of 195 lbs. I have pictures for proof and will keep everyone posted that gives a rip. Also as of today I have written 74 rx's and turned down about 14 patient requests for Belviq.( did not meet criteria)
---

Two days on Belviq and 3 lbs lost ! I did walk 2.5 miles am and pm both days but I have also done that since getting back from the UK 2.5 weeks ago. My calves are slightly sore but the belly is smaller for it. 234 lbs and counting......just not as much !



Almost 2 weeks on Belviq and I am down almost 7 lbs!
Belviq is "Will Power in a Bottle!" I can't tell you how many times I passed up my favorite foods and second helpings! I am just not hungry anymore!


lost 10 pounds on Belviq in about 12 days


Started a low-carb diet on Friday June 7th, weighed 254 pounds, started Belviq on Tuesday June 11th, weighed in with Dr Nguyen this morning weighed 244 pounds.
That is 3.9% weight loss in 10-14 days.
Diet has been easy, no side effects at all, never want a second portion, I sleep better, [I sometimes get insomnia, worrying about my business, etc. That is G-O-N-E]. I do not feel like I am missing out.
I like desserts but now have a tiny portion of nuts or cheese or non-fat yogurt. I tell myself I can have more if I want but I never get up to get more, last couple of nights I skipped the dessert altogether, which is pretty significant for me.
Another important point is food smells and tastes GREAT.
Last night was one hamburger patty, and a skewer of brussel sprouts, onions, tomatoes. That's it. Didn't feel like dessert.
I walk 2 miles about 3 times a week, and want to get up to 6 or 7.
My work is very hard labor about 40% of the time, so I have always been physically active.
Belviq has been a big success for me, and if it was not you know I would not hesitate to say so.
¡Viva Belviq!


--------------------------------------------------------------------------------

A New Day
From:

http://belviqdaily.blogspot.ca/

This morning, I got the RX filled by my pharmacy and I took my first dose at about 10:00 am. For lunch, although probably not ideal for weight loss, my coworkers treated me to an already pre-planned lunch. Mexican food is one of my weaknesses. I CRAVE salsa and can usually go through 2 bowls before my meal even comes out. I always, for the most part, finish my plate. Today, I ordered the taco dinner. It comes with the standard beans, rice, and had 3 tacos. I didn't realize that I only had 1/2 small bowl of salsa before my food came out. By the time I got my food, I was already feeling "full". I ate 1 taco and that was it! I was full.

So, is this a sign that this will really work? So far, my mind isn't consumed on eating - which is not normal for me.


--------------------------------------------------------------------------------

LOST WEIGHT IN JUST 2 DAYS WITH NO SIDE EFFECTS

Belviq (lorcaserin) for Obesity: I just started taking this medicine and completed 2 days thus far. I have noticed that my interest in food, especially the unhealthy stuff, is gone. Even the foods that usually are great at tempting me really have no effect at all. They all of a sudden have become easy to resist. Furthermore, when I do eat, I definitely don't eat as much as I feel full sooner. I also noticed my mood has improved. In just 2 days I have lost just over 1 lb. My doctor did advise me that Belviq should be combined with diet and exercise. I am older so exercise becomes problematic as my joints are stiff. Anyhow I believe this medication will be helpful to those patients who tried everything and failed. I have had no side effects at this point although it is soon.

--------------------------------------------------------------------------------

LOST 12 POUNDS IN 5 DAYS

Belviq (lorcaserin) for Weight Loss: I am a 6 ft guy, weighed in at 241lbs, with hypertension. If I didn't lose weight I was in need of a new blood pressure medicine and possibly cholesterol medicines. I have taken Belviq 5 days and lost 12 lb with no side effects. Thumbs up to Belviq!

--------------------------------------------------------------------------------

LOST SEVERAL POUNDS IN A COUPLE OF DAYS

Belviq (lorcaserin) for Weight Loss: I've only taken belviq a couple of days, but already I've lost several pounds and my desire for food, alcohol, and sugar. Today is day three and I do feel so good. I'll add more info as time progresses.

--------------------------------------------------------------------------------

VIDEO IN DOCTOR'S OFFICE

http://belviqdaily.blogspot.com/2013/06/the-weigh-inare-you-ready.html


--------------------------------------------------------------------------------

LOST 60 POUNDS

I was part of the clinical trial in Utah. Apparently I was a 'responder' as I lost 60 pounds in the first year of the study (my starting weight was 279). I didn't diet; but I tried to maintain a caloric intake of 2000-2500 calories per day. I found this to be easy because the medication took away the hunger pangs. I didn't change my physical routine which could be described as somewhat sedentary (I didn't run or go to the gym). The second year on the placebo, sticking to the caloric intake range was more difficult and I eventually gained back half of the the weight. I think for those obese persons (over BMI of 30) who respond to the treatment, this is a viable option compared to the risks of obesity. I had zero side effects; including no negative affect on heart valves.v

--------------------------------------------------------------------------------

BIG CHANGE IN APPETITE

Belviq (lorcaserin) for Obesity: I just picked up Belviq over the weekend and I can say that I noticed a big change in my appetite. It's as if I have no energy to eat more than I have to and my stomach feels more full sooner into the meal so I eat less. Now I have tried many diets, many weight loss supplements without success so I was skeptical. Belviq is different. Instead of messing with your metabolism, it focuses on the appetite center and nothing more. I have had no side effects! Unlike the others I have tried in the past such as anxiety, nervousness, headaches, palpitations. I'm motivated to finally lose that 30 lbs my doctor keeps yelling at me about!

--------------------------------------------------------------------------------
LOST FOUR POUNDS IN A FEW DAYS

Belviq (lorcaserin) for Weight Loss: I talked to my doctor about Belviq and got a prescription last week. So far I have lost 4 pounds and feel great. It's like I am suddenly motivated to lose weight. I think as the weight comes off exercising will become easier. I am tolerating the medication without side effects. I noticed no appetite for food and a boost in energy without the nervousness I felt with some of the over the counter products I used to take. I have told my friends and family about Belviq.

--------------------------------------------------------------------------------

LOST SIX POUNDS IN A WEEK

Belviq (lorcaserin) for Weight Loss: I was waiting a long time for Belviq to come out. It's been close to a week and I've lost over 6 lbs. Pretty impressive. Yes I am dieting and exercising but I am eating less. I just don't feel like eating anymore! I am hoping to lose 20lbs in 6 months. I got a real good chance here. I don't feel any headaches or nausea like my doctor said.

--------------------------------------------------------------------------------

5 full days on Belviq
"After 5 full days on Belviq I can assure you this is going to be a wildly successful product. It has made sticking to a diet of reduced portions and healthier foods EASY. I can now eat half what I used to and feel completely full. It has eliminated my compulsion to snack when watching tv or a movie and the results are already noticeable. I started Belviq weighing 227 and as of this morning I was at 222 (after only 5 days). I'm not starving myself, just eating the amount I should have been eating for the last decade. So the 3-3.7% weight loss numbers "analysts" keep quoting is a complete joke. I believe I will achieve 10% weight loss in only a couple months and I know I will have Belviq to thank. The only side effects I have noticed thus far is being able to fall asleep faster and having a more upbeat and positive attitude in general."

"This really feels like a new chapter in my life. After 3 yrs of anxiously waiting for Belviq to hit pharmacies, I imagined the effect and weight loss would be subtle in a year. I am overjoyed that it's far more effective than that"

"From the 1st pill I have done my best in attempting to separate wishful self weight loss hopes from the reality of Belviq. I know Belviq is having an effect because it has been PROFOUND. If I dared to eat as little as I am now without Belviq food would be on my mind 24/7. Instead it feels like I can eat like I'm supposed to without the craving monkey on my back. "


--------------------------------------------------------------------------------
Couldn't be happier


I have taken Belviq for about a week now and I couldn't be happier with it. I have cut my portions down by almost 2/3 of what they were and the lbs are coming off! I don't know about you, but the only side effect I have experienced so far has been falling asleep faster and sleeping better. Not bad :)


--------------------------------------------------------------------------------

"I Felt Full Already"

Good luck with your weight loss quest. Started my own today. I took my first Belviq pill. No side effects so far. I just tried to eat dinner, got through my salad and and only had a few bites of main course when I actually felt full already. I stopped eating. As far as insurance I have Aetna and a very good Rx plan, I paid $5 for the 30 day supply, my doc wants me to see him in 30 days to decide where were going from there. I have BMI 31 and high blood pressure which I take medicine for.

t was weird, its like I was eating and mentally I felt I was done. I stopped eating and told myself "You don't have to clear your plate" I have to take 2 meals a day to work as I am here 10hrs I work 2Pm to midnight. So I guess I will be bringing smaller portions. My wife is not taking Belviq yet but I think she will soon.(I'm the test case) Her endo had her try Q [QSYMIA] but it made her feel really bad so she quit. We are working on changing what we eat to more natural and less processed foods. Hoping Belviq will help this quest along. Getting thinner in the waist and thicker in the wallet(wink).

--------------------------------------------------------------------------------

Back with the little blue pill

Yesterday I took a 2nd dose very early, about 6 am. Had an aquatic workout in the day but had no compulsion to eat until about 7 pm and again, I clearly felt the effect of impulse suppression. Though I ate about 90% of my usual intake last night, the day before (my first day taking Belviq) I estimate my food intake was only about 2/3 of what I usually consume. Other, very notable positive effects include a general state of mild euphoria and - for me - about halving of my tobacco intake; I dip, do not smoke, but only had 5 dips yest and the day before when I otherwise would typically have 8-10 dips through the day.

Both the eating and dipping reductions are very significant IMO as I'm really trying Belviq to make my own subjective guage on the effect of this drug. My BMI not bad, not overweight and I'm not really interested in quitting my dipping at this point. After my 2nd day of trying Belviq, I continue to believe Belviq will be very well tolerated and for those such as myself who note a positive response, will do very well with both appetite suppression AND tobacco cessation (clearly, ARNA will need to do clinical investigations vis a vis smoking cessation but I have little doubt they are already planning for this in the future and would not obviate Belviq being used effectively off label for this purpose).


--------------------------------------------------------------------------------

Better Control of Blood Sugar Even For Type 1 Diabetic

type 1 diabetic that is on Belviq and is losing weight but more importantly is having much better control of his blood sugar allowing him to use less pens a day.


--------------------------------------------------------------------------------
Combo With Phen


"My dr. wants me to take 1/2 phentermine in the am and take the other half w/a belviq in the afternoon - I'm on day 3 and feel good. Phentermine was okay on it's own but didn't do a whole lot"


--------------------------------------------------------------------------------
No Adverse Side Effects

I have had no adverse side effects. BMs 100% normal, though I do not have DM or any other metabolic/serious medical condition.
--------------------------------------------------------------------------------

I've been in Belviq for 7 days .

Day one 215 lbs . Day seven 207 lbs . I have no desire to eat a bag of chips , or a box of Klondike Bars .. I fill up fast and never have the munchies . I felt good about the science , but being on Belviq and experiencing it first hand is unbelievable . I havent experienced any known side effects . No doubt Belviq will be the best selling drug of all time . I also know 6 others on Belviq with very similar results ..

--------------------------------------------------------------------------------

DOCTOR SAID IT'S SAFE - BELVIQ WORKED IMMEDIATELY

Picked up a prescription for it Monday and my doctor assured me several thousands of patients had been studied with no serious adverse reactions.
I started on it today and for the first time I can recall (years), I had two mixed green salads with no dressing or caloric add ons. I only ate because I wanted to join the family but honestly, I did not even feel like eating and even passed on dessert. I have a very addictive sweet tooth and always eat dessert. I think Belviq will be a major step for me reducing my weight and improving my overall health.

--------------------------------------------------------------------------------

Note on one script
My wife took B yesterday. Food craving definitely down. Sex craving unchanged. Looks like I'm a double winner.


--------------------------------------------------------------------------------

16 days on Belviq

On June 14 I was at 227. Now 16 days later I've dropped 9 lbs to 218. Sticking to a greatly reduced calorie diet continues to be easy as the voracious appetite I once had just isn't there anymore. Once you get used to smaller portions the effect is compounded by a smaller stomach which makes sticking to the diet even easier. The biggest difference from dieting now and in the past is when I would avoid bad food to maintain a diet in the past the cravings to eat those bad foods would be overwhelming and ultimately I would fall off the wagon. Now with Belviq, staying on the wagon is quite easy. Those bad food cravings are almost non-existent and now I can easily stick to a diet of smaller portions. I thought initially I would ask my doc about combining with fent** but now I know Belviq as a single agent is plenty effective enough. There continues to be zero side effects.


--------------------------------------------------------------------------------

Lost 50 pounds on BELVIQ
•This gentleman lost 50 Pounds on BELVIQ.


--------------------------------------------------------------------------------


One Full Day on Belviq...
After spending 3 years following Arena & lorcaserin and investing quite a large chunk of my portfolio (not to mention needing to lose about 40 lbs) I saw my doctor and he reluctantly prescribed me Belviq. He was hesitant because he had not heard of it before I filled him in and when I mentioned the similarities between lorcaserin and fenfluramine he shuddered a bit (understandably). Of course I mentioned the 9k patients received echos in phase 3 and there were no signs of any cardiac event, but then he countered with "when exposed to millions sometimes drugs...." I'm sure you know the rest. Still his interest was piqued and he decided to let me be the first in his office to be prescribed Belviq. The local CVS in Dallas did not have it in stock but they ordered a bottle and it was there the following day. I filled my prescription yesterday evening using the voucher for 2 weeks free and took my 1st 10mg this morning at 9am and 2nd around 5pm today. I woke up quite typically this morning, annoyed and craving a chick-fil-a chicken biscuit. I felt the onset of the medication almost within 15 minutes although it was subtle. I was still hungry but I wasn't craving chick-fil-a anymore. It almost felt as if something healthy was now "ok" with my brain instead. I had some oatmeal and actually felt full after a small bowl! I'm not sure if I was just happy that Belviq was seemingly working or it's effect on the 2c receptor was causing a particularly good mood but I felt reeaallly positive today. I had a fairly typical light lunch for me and dinner around 6:30. The portion I ate at dinner was only about half of what I would have had usually and I truly felt full. It's effect on my brain doesn't feel like something strange is happening but rather something very familiar. It's honestly quite similar to a post meal feeling of contentment and well being. I can't wait to continue on with this drug tomorrow and maybe for quite a bit of time to come. Belviq is going to a big deal.


--------------------------------------------------------------------------------


My first week on Belviq STATS (6 days)
I will update this each Saturday so we have a continuous record of my results. For the first 6 days:
Regular Insulin (before meals) started at 30 units three times a day. I now take 14 units 3 times a day.
Overnight Insulin (overnight coverage) started at 30 units. I now take 18 Units.
My weight started at 201 Pounds and as of this morning I weigh 195 Pounds.
Please note my exercise regimen has been limited to walking 1 mile per day.


--------------------------------------------------------------------------------

Using Belviq for 10 days,
today would be my 10th day on Belviq- first 2 days noticed no difference or side effects- HOWEVER, over the last week I can truly say I have had a decrease in appetite both the amount of food I consume each meal and the amount of meals.( about a 20% decrease)


--------------------------------------------------------------------------------

DAY 14 REPORT

Day 14 I'm down to 204 from 215..I have always worked out 5 day a week and continue to do so. My whole life I've been a gym rat. However, the 25 Ibs. I've tried to lose for many years is finally coming off.

I also have a hiatal hernia and carried extra belly fat which caused me to have plumbing issues. When I would overeat, food would get stuck on the way down which would caused me to throw up violently. Since Ive been on Belviq, I haven't thrown up once. My doctor ask me years ago to lose 25 lbs which would help out with that issue. Until now, I just couldn't lose the weight.

I eat an average breakfast eggs, bacon and toast with juice or chocolate milk. Most days I just don't get hungry at all. I have to force myself to eat most days. In the past, I would eat 3 to 5 meals a day, along with my chips and 4 to 5 klondike bars. This past week I've had 2 bars for the week. I just have no cravings at all.

Side effects, I think I felt weird for a few days. I think it's from my body just getting used to less food. I seem to sleep longer. I have had a few long lasting erections. I seem to feel much more positive, perhaps due to the weight loss.

If this isn't a magic bullet, I don't know what is. It's been amazing for me.



10 days, 11 lbs.


and on the last belt loop now. 4 from the start. it is amazing. no side effects for me. I just do not crave food any more. Thank you dr vig for telling me about this a couple years ago.
I still do not remember if you told me as an investment or weight loss or both. I did both now!...


--------------------------------------------------------------------------------

Size 36

Looking forward to size 36 jeans again.


--------------------------------------------------------------------------------
No Side Effects

Started BELVIQ this week NO SIDE EFFECTS. Has already started to work in that I am not hungry, I have to force myself to eat for nutrition. Any health professional who has the ability to prescribe drugs can write a prescription for Belviq. Due to the newness of this drug many doctors, etc will not have heard of it. Just insist on them to prescribe for your life wellness.


--------------------------------------------------------------------------------

Tried the little blue pill

Retired MD. Intrigued by receptor selectivity, exhaustive eval for possible ADRs, valves etc during clinical investigations, efficacy and potential for positive "side effects", I've been waiting to give Belviq a trial run on myself. Got a Rx filled today and did not eat anything all day, though not unusual as my big meal is always supper, rarely refusing dessert (very active sweet tooth).




Did not want to eat supper but sat down with my family and had two mixed green salads with no dressing or add ons. I never, ever recall choosing to eat salad without jazzing it up with dressing or some big caloric add on and I do love my salads. I passed on dessert. Very noticeable effect on my usual pattern of end of day near compulsive eating. No ill effects at all; felt cognition was stimulated and while not a big party drug, for me, at least a mildly euphoric effect. I think Belviq will be a very well received drug.


--------------------------------------------------------------------------------

Belviq in hand!

I'm a 260 lb, 42 year old male, business executive, (4 small kids at home), don't get too much time to exercize during the week. I'm a 32 BMI. I graduated college around 220 lbs, and my goal weight is between 200 and 210.

I had a dr. appt. scheduled for June 7th. I printed out the 15 day free trial from the website and brought along. My doctor had never heard of Belviq, but kind of shrugged his shoulders and said, "I don't think it will work for you, but I'll write the script.." I expected this lack of knowledge so I was happy to just get the prescription. He asked to see me back in 30 days to check progress. On June 10th, I went to RiteAied, Walgreens, Target, Walmart--no one had heard of Belviq and no one had it in the distribution system to order. Several told me it was not an approved drug and to immediately call my doctor. I called around on the 11th, and magically!--Target had it show up as a drug avaiable to order! They still had never heard of it but were happy they could place a next day order and fill my script.

So I got Belviq on June 12th and have take two pills so far. Already, I can tell this will make a big difference for me! I'm not hungry at all. I have a little 'tingling sensation' at the temples (like after a venti latte), but beside that just a complete lack of appetite.

I will log on every couple of days to provide an update!


--------------------------------------------------------------------------------

WOW BELVIQ CALL CENTER!

So busy 15 min hold! Savings card and voucher can be mailed to you! Nice lady said they are non stop calls comming in!

--------------------------------------------------------------------------------

Have my Belviq prescription
Took script yesterday Tuesday to small independent pharmacy price $240/month
picked up prescription this afternoon, was no charge, 15 day supply, nice.
Pharmacy said I am the first Belviq prescription.
Took pill immediately, 2pm, these Belviq pills are tiny.
Ate a snack of Cotto Salami and Havarti cheese, not much, went to Home Depot and did repairs around house, operated heavy machinery[!], everything ok, feel nothing really
8pm Fired up BBQ and grilled 2 6oz tuna steaks and brussel sprouts for spouse and I.
Had a cup of mixed nuts around 10.
Taking 2nd Belviq pill now.
Feeling just like normal, no side effects.
There were no "seconds" available for dinner tonight, but guess I did not miss that, [I usually get "seconds"]
sometimes truth is boring, oh well.

--------------------------------------------------------------------------------



Day 1 Belviq
Picked up script yesterday. First customer for Belviq. Started Belviq today. My weight was 215.4. Went to gym, did 35 minutes cardio on level 15, highest heart rate was 105. Did regular workout routine, no apparent side effects. Came home and had a grapefruit. After first section, I felt full.

Am not hungry and have no desire for food.


--------------------------------------------------------------------------------



I am already seeing good results after just ONE Day
My Naked Weight measured the same 250.8 pounds yesterday and exactly 250.8 pounds this AM; however, my Fasting Glucose yesterday was 164 and this morning it measured 102 and I swear by these numbers. This is huge already 102 is a perfect reading, I am already thinking of reducing my Humalog from 40 units down to ~ 30 units, I have not taken the meds yet, I am taking some time to really think how much Humalog I should take, I am thinking about 32 units so that my reading before lunch does not go below 80 (now, I might have to add the lunch reading to the spreadsheet given the fasting is showing normal numbers)


--------------------------------------------------------------------------------


Real life story from peson who took Belviq.
Martha: I was in the last Phase III 2 years study. Lorcaserin has been approved by the FDA and will be distributed soon. It IS NOT A MAGIC PILL. Just helps to control appetite and gives you an edge. You still have to diet, plan meals, AND EXERCISE. I lost 52 lbs in one year on it. Helped me to walk away from food and not CRAVE, CRAVE, CRAVE all day. Very few side effects. I had some dry mouth and eyes, a little more fatigue at first, and the great side effect of being able to fall asleep quickly. I stress at night and couldn’t fall asleep. Now I can, still, even after being off it for 2 years. It retrained my brain.
Leslie: I did this study for the 2 years! I did lose 57 lbs.the 1st year.The second year I gained a small amount back (did not really stick to a 1700 calorie diet,so it was expected)I did have alot of energy,my cholerterol did improve & It did control my hunger & cravings.I got my letter just the other day(march 1st,2013) that states I was given the lorcaserin for both years (not the placebo)I would love to go back on the lorcaserin, I am searching places now to get it,as it is on the market now. Also I never had any s*de *ffects or h*art problems(we went to hospital for check ups & ekg every 6 mos)we also had a doctor on site, to monitor us when we had our appts. We had regular blood draws at each appt as well.My friend started the same time as I did,only to quit after about 9 months into the study (I think she must have got the placebo,I did not ask yet if she got her letter)overall I was satisfied with the results & do reccomend trying Lorcacerin!


--------------------------------------------------------------------------------

Day one on Belviq
Had little sleep last night due to the heat and a toe injury taking down a wall in my basement last night.

Took a dose around 8 a.m. and didn't think to eat until around 1:30 pm when I was feeding the baby. I didn't have much. I was excited to take the baby out to the play gym and slide that I put together during his nap. Took a second dose at 4 p.m. I had a mild transitory headache(15 minutes) that I'm attributing to the heat and lack of water.

Its not unusual for me to miss a meal without thinking about it. Almost always, at the next meal I dig in with gusto. We have some guests coming over tonight and the wife is cooking something good. We'll see.

At this point I have no clue whether I'm a responder or not. On similar days in the past, I would be ramping up some serious hunger by now. Now, I'm a little hungry, but its not much. Hard to explain.

--------------------------------------------------------------------------------

Losing weight without trying hard

"Belviq user1 said he is enjoying BELVIQ, too. He is losing weight, controlling his cravings without even having to try very hard. And he said he has a friend, whose father-in-law is an even bigger, heavier man who is also losing weight on BELVIQ."
CVS visit... BELVIQ "selling like hotcakes"
I went to pick up a prescription at my CVS in Bergen Coiunty, N.J. (Paramus area) and I have spoken to both pharmacists...
just as I was leaving with my prescrption I turned to her and asked if she ever heard of Belviq.

Her answer was in one word and I am not exagerating) HOTCAKES. She said to me that the prescription was selling like hotcakes.

FIRST PILL

Took first pill this evening and got a low sugar reading within an hour of having dinner...
I want to get back to my 195 avg weight. I've had a slow healing foot problem for the past ten months and quickly shot to 226 at my heaviest.
Been looking forward to this little blue pill to get a kick start on my road to healthyness again


Progress Monitoring Spreadsheet
Early signs after one pill this AM:

1) Been munching on a Fat Free Fig Newton Bar since this AM instead of my usual Sausage, egg and cheese on a Croissant with a cup of coffee from Dunkin Donut every morning.
2) felt a little of nausea due to empty stomach; however, there was no craving for food. I just had a Cup of soup for Lunch with some croutons and the nausea feeling went away.
3) I have been smoking a cigarette since this AM every about 1.5 hours instead my usual 1 hour interval.

Will be posting my progress spreadsheet every weekend on Saturday GOOD OR BAD, it will only state the FACTS about my progress

--------------------------------------------------------------------------------
DOCTORS

NOTE FROM DOCTOR


Patient lost 5 pounds after being on BELVIQ for a few days
"I saw one patient with United insurance today who started Belviq a few days ago. He says he has no side effects from the medicine and simply does not feel like eating so much. I was surprised to see that he has lost 5 pounds since his last visit with me that happened to be less than two weeks ago."



NOTE FROM DOCTOR

doctor Vig and Belviq prescriptions this week

Today is Friday, 6 14 2013, before my clinic starts. From monday through thursday this week I gave prescriptions of Belviq to 19 patients, which is over 4 patients per day. I have handed out a number of Vouchers for the free 15 day supply of Belviq, which is accompanied by a prescription for the 15 day supply of Belviq. I am also giving the patient a monthly prescription of Belviq, which can be refilled 5 times. Both prescriptions are printed on our blue tamper proof paper. I am giving each patient a handout on diet tips, and a second handout about Belviq. I have filled out some prior authorization forms and faxed them to the insurances. A couple of patients who were on medicare and did not have insurance coverage of Belviq were going to use the Voucher, followed by cash payment for Belviq using the Savings Card from the Belviq web site. Cash price of Belviq at CVS across the street is about 209 dollars per month, and the Savings Card will decrease this by 75 dollars per month to 134 dollars per month, and can be used monthly for up to 12 months. I sent a group email to our Carondelet doctors here in Tucson about Belviq. I also send an email to a doctor at Arizona Community Physicians, another large group here in Tucson, and the doctor offered to send the email to those doctors. My patients are excited about trying Belviq for weight loss. I have given Belviq prescriptions to a total of 178 patients so far over the last few weeks.
Steven Vig md internal medicine tucson arizona friday 6 14 2013


--------------------------------------------------------------------------------
NOTE FROM DOCTOR

I see 20-25 patients per day in my office. The day Belviq was in the pharmacies, I Rx'd eight people. These are patients who have BMI's over 30. They have tried everything else under the sun to lose wt. Their family members confirm that compliance has been observed in terms of not cheating with diet, exercising regularly and in general trying to maintain as healthy a life style as possible. They are suffering varying degrees of comorbid problems and were absolutely giddy when they learned that this NEW medication was available. The fact that they could take something that would not keep them up at night or cause palpitations was key for them. To date, I have Rx'd 28 patients in my small practice.


--------------------------------------------------------------------------------
NOTE FROM DOCTOR
Medical Assistant Misses Lunch by Doctor Vig
A medical assistant at my office has been on Belviq for several days.
On Wednesday, I noticed that she was still working on her computer at
lunch time. The other medical assistants had gone to lunch, so I
asked her if she was going to lunch. She said that she just “wasn’t
hungry” and she had decided to “skip lunch”. I have NEVER seen this
medical assistant miss lunch before! She also said that she had
decreased her food intake in the evenings. She “felt full” and did
not feel like eating very much food at night. She said that she was
already beginning to lose weight. She has a history of headaches, and
I asked her if she was having any headache problems, but she said that
she was not having increased headaches. She said she felt “just
fine”. Time to maximum concentration after a single pill of Belviq is
about 2 hours. The half life of Belviq is 11 hours, and steady state
concentration is reached after 3 days of dosing when given at 10 mg
orally twice a day, with or without food. Patients should feel
maximum effect of Belviq after 3 days of dosing. Risk of headache is
about 16% compared to 10 % on placebo, so it was encouraging that the
medical assistant was not experiencing headaches. We know that Belviq
works according to the clinical studies. It is encouraging to see
positive effects of Belviq first hand.
Steven Vig md internal medicine Tucson, Arizona 6 21 2013


--------------------------------------------------------------------------------
NOTE FROM DOCTOR

I've written just a few Rx's for Belviq and as far as I know only one of them filled it so far. That person gave me feedback that was surprisingly positive regarding hunger cravings, mood, side effects etc. But even more surprising, and out of the blue because I hadn't even thought of it much less addressed it, was that this person said they were consuming about half as much tobacco as normal. I'm not one for putting (too) much value on early pipeline drugs but anecdotally this is remarkable since cutting back on tobacco is associated with undesirable weight GAIN. Guess instead of saying Belviq costs a starbux a day, might-could say it costs a half-pack a day.


--------------------------------------------------------------------------------
From Patient: Summary after 7 days on Belviq:

(FROM A PATIENT)

Today's fasting Weight = 246.0 # = (-1.9%) from 250.8#
Fasting Glucose this AM = 101 mg/dL
Insulin Intake yesterday = 74 units instead of 100 daily units
AMAZING Glucose readings yesterday:
Fasting = 114
Before Lunch = 73
Before dinner = 99
2 Hours after dinner = 122
============
Date | FW | % WL | AMF | NBL | PMB | PMA | Belv | Glum | Huma | MBV | Cigs | Ex
6/13/13 | 250.8 | 0.0% | 164 | NM | 216 | 173 | 10-10 | 0.5-1.0 | 40-60 | --- | 18 | ---
6/14/13 | 250.8 | 0.0% | 102 | 106 | 193 | 85 (*) | 10-10 | 0.5-1.0 | 32-60 | --- | 19 | ---
6/15/13 | 251.6 | 0.3% | 145 | NM | 150 | 182 | 10-10 | 0.5-0.5 | 40-52 | --- | 27 | ---
6/16/13 | 251.2 | 0.2% | 118 | 135 | 187 | 158 | 10-10 | 0.5-1.0 | 32-52 | 1C-1C | 20 | Ex7
6/17/13 | 250.6 | -0.1% | 115 | 118 | 163 | 139 | 10-10 | 0.5-1.0 | 30-50 | 1C-1C | 20 | Ex7
6/18/13 | 246.9 | -1.6% | 112 | 105 | 144 | 166 | 10-10 | 0.5-1.0 | 30-48 | 1C-1C | 19 | Ex7
6/19/13 | 246.6 | -1.7% | 114 | 73 | 99 | 122 | 10-10 | 0.5-0.5 | 28-46 | 1C-1C | 23 | Ex7
6/20/13 | 246.0 | -1.9% | 101 | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX | XXX


--------------------------------------------------------------------------------


ON SSRI interaction (off various forums -- owner of this page can't guarantee its accuracy -- this is not a medical advice -- ask your doctor for proper advice )

If you're referring to Serotonin Syndrome, which has a rapid onset, is in fact associated with SSRI's such as Zoloft and fortunately it is very rare (one death back in 1984) with most cases ending within 24hrs.Serotonin Syndrome is due to excess serotonin at the serotonin receptor 5-HT1A This receptor is found in multiple areas of the brain Except the Hypothalmus. I suppose anyone taking an SSRI such as Zoloft should be advised of the slim risk of Serotonin Syndrome.But, Belviq's mechanism works on a completely different receptor than SSRI's, the 5-HT2C receptor. It's action is completely different than SSRI's. According to the College of Psychiatric and Neurologic Pharmacists there is an unmeasurable and theoretical risk of that syndrome with belviq and the risk doesn't increase when Belviq is dosed with SSRI's. Qsymia on the other hand increases the risk of suicidal ideation and depression amongst other side effects.
~~~~~~
the 5-HT2C receptor is located in the Hypothalmus so Belviq acts on a completely different part of the brain than SSRI's.
~~~~~~
There is no evidence that Belviq significantly increases serotonin levels, although it does slightly inhibit metabolism of some drugs that boost serotonin. People get confused by the fact that Belviq is classified as a serotonin receptor agonist. This doesn't mean that it stimulates secretion of serotonin -- it means that it mimics serotonin in activating those receptors.

Although serotonin syndrome can be a very serious condition, it only becomes so after extended high exposure and could quickly be arrested by simply discontinuing the use of Belviq, if Belviq were the cause. Watching for it is a reasonable precaution to take for someone on a drug that could raise serotonin levels if not metabolized at a normal rate, but that doesn't mean that anyone on an SSRI shouldn't be given Belviq. In any case, this would apply mainly to use with antidepressants, not with anti-psychotics.
---
Although Dr. Vig's slide show contains a lot of good information, his coverage of serotonin syndrome is inaccurate. Some people have gotten upset with me for stating this, because he's an MD and I'm not, but wrong is wrong.

In the slide show narration, he says, "Since Belviq stimulates the serotonin receptor in the brain, you might get elevated levels of serotonin in the brain if you combine it with other medications that raise the serotonin level." But that's not accurate.

Serotonin receptors are not receptors that raise the level of serotonin. They are receptors that respond to serotonin. Belviq acts on a serotonergic pathway by stimulating a receptor that is also stimulated by serotonin, but the concern that this will raise serotonin levels is purely theoretical and is based mainly on the lack of trial data that could guide us on whether a real risk actually exists.

Almost all CNS agents carry a caution about the possibility of serotonin syndrome, because brain chemistry is complex and poorly understood, and serotonin syndrome can be very serious if untreated. If serotonin syndrome were to arise from initiating Belviq, it would happen within the first day or two of treatment and could be completely reversed by discontinuing the drug. So caution is warranted, but that does not mean that anyone taking an SSRI has to choose between their antidepressant and Belviq.
~~
Belviq is not an SSRI. It has no effect on serotonin re-uptake nor does it stimulate the release of serotonin. It has a mechanism of action that mainly activates just one subtype of serotonin receptor (5HT2C -- there are 7 types and over 20 subtypes), which actually inhibits the release of dopamine and norepinepherine in specific parts of the brain where those receptors are located.
~~~
I expect that the lorcaserin label will caution against use by people taking SSRI drugs like Prozac. In the Arena trials, subjects on SSRIs, or even who had taken them in the last year, were excluded. The reason for this is concern over a condition called serotonin syndrome which is essentially serotonin toxicity that can occur if serotonin levels are too high. This is a relatively rare condition and easily detected, and it can easily be reversed by simply discontinuing the serotonergic drugs. But it can be fatal if untreated, so it is a concern.

Under a doctor's care and monitoring, however, patients on Prozac could be given lorcaserin and then checked for symptoms of serotonin syndrome, which would occur soon after treatment began, and which does not quickly progress to a dangerous level under such conditions.

Prozac does sometimes cause weight loss, and the reason may be that its more generalized effect on serotonin levels hits the same receptor that lorcaserin activates. The difference is that lorcaserin is highly selective in its action.
~~~~

IN MY PRACTICE, I TALK WITH THE PATIENT TO SEE IF THE PATIENT WANTS TO TRY TO GET OFF THE SSRI ANTIDEPRESSANT IN ORDER TO TRY BELVIQ.... SOME PATIENTS ARE WILLING TO TRY THIS, AND SOME PATIENTS ARE NOT WILLING TO DO THIS.... A PATIENT ON PROZAC CAN SIMPLY STOP PROZAC AND NOT HAVE TO TAPER IT SLOWLY , SINCE PROZAC HAS SUCH A LONG HALF LIFE... A PATIENT ON PAXIL, FOR EXAMPLE, WHICH HAS A SHORT HALF LIFE, SHOULD TAPER THE PAXIL OVER AT LEAST A COUPLE OF WEEKS TO AVOID SSRI DISCONTINUATION SYNDROME, WHERE PATIENTS FEEL BAD FROM RAPID WITHDRAWAL OF THE SSRI AND MAY EVEN GET WHAT ARE CALLED "BRAIN ZAPS"...






--------------------------------------------------------------------------------

OFF LABEL

"If they ask for it, they will pay it. $200 a month for vanity is a small price to pay for many - especially females. Women spend more money every year on vanity than most people realize - makeup, hair, nails, special diets, gym memberships, breasts implants and other cosmetic procedures, clothes that make them "look smaller or sexy", shoes, et al. The list goes on and on. $200 a month to lose weight is a small price to pay relative to all the other vanity costs in a year. And by the way, many men fall into this category as well, not just women - they spend the money on other vanity items. Off label will be huge and there is a portion of the American society that can and will pay out of pocket every month."





FWIW off label use. (BELVIQ for quitting smoking, etc.)



My brother-in-law has been on Belviq 5 days


and says his craving to smoke is much lower. Smokes two packs a day and today said he smoked a pack and 4 cigarettes. Lost 2 lbs. I sure hope these off-label uses mushroom. If we can get 1 million chronic users that should be worth $50 pps.
Doc SPEAKS
I started offering prescriptions to our mostly nursing staff two days ago as a courtesy and only when I overheard them discussing weight loss techniques/problems, giving appropriate counseling etc. Five women asked for and received Rx's from me Monday and Tuesday. All were off label.

LOWER ALCOHOL CONSUMPTION

In my case, it's less alcohol consumption, (wine).

When I eat less at dinner because I'm not as hungry, I drink a glass, (or two), less of wine. I'm sure that that was contributing to my pre-T2D condition.

And, even after dinner, I'd "nibble" on that bottle till it was finished- it was my form of "dessert".

Now, my appetite for "desserts" has gone way down and I find myself corking the bottle after dinner.

Empirical evidence for sure, but it's working for me.

OFF LABEL - BELVIQ FOR QUITTING SMOKING

I've added smoking cessation to prophylactic weight loss as off-label indications for prescribing Belviq. My first two patients on Belviq who were smokers have reported and (so officially "in my experience, patient after patient"experienced 50% overnight decrease in tobacco consumption alongside moderate weight loss and positive moods. Just a matter of time before this goes viral in the sports community eg body building, weight class sports etc








COPYRIGHT NOTICE: ALL AUDIO AND VIDEO RECORDINGS, WRITINGS, COMPILATION, AND OTHER WORKS BY REZA GANJAVI ARE PROTECTED BY COPYRIGHT LAWS. ALL RIGHTS RESERVED.

👍️0
PoemStone PoemStone 12 years ago
Hi umiak! Nice ticker.
👍️0
PoemStone PoemStone 12 years ago
flemsnopes. Looking in, nice. B'marked.
👍️0
umiak umiak 12 years ago
Another great interview. Obviously ReXceptor Inc. is not public. It is odd the ESALY connection is not mentioned in the interview.
👍️0
flemsnopes flemsnopes 12 years ago
Heavy stuff. +2.79 (6.65%)

FDA approves Arena's weight-loss drug Belviq
http://www.sfgate.com/health/article/FDA-approves-Arena-s-weight-loss-drug-Belviq-3668682.php
👍️0
flemsnopes flemsnopes 12 years ago
Is Bexarotene Ready for Alzheimer's?
http://alzheimersweekly.com/content/bexarotene-ready-alzheimers
👍️0
umiak umiak 12 years ago
It is very promising. Sky's the limit if it works.
👍️0
flemsnopes flemsnopes 12 years ago
This potential new indication could elevate bexarotine to major blockbuster level if there is any promise shown in human trials, and while I have no idea how quickly data might begin to come in, it seems intuitive that a drug already on the market could be "fast tracked" rather easily. Any positive trials, official or unofficial, will likely spread like wildfire across the internet. The valuation on a truly effective Alzheimer's treatment would be mind boggling. (no pun intended)
👍️0
umiak umiak 12 years ago
this is what really got my attention, it is a re-work. Drug is already in the system and approved by fda, yet boom, shows great results for a another troubling disease:


http://www.prx.org/pieces/75327
http://gel-server1.cwru.edu/
👍️0
mick mick 12 years ago
no wonder in sky pps...product must be good.
👍️0
umiak umiak 12 years ago
btw this is arena's distributor
👍️0
umiak umiak 12 years ago
mick, you are making me dizzy! lol
👍️0
mick mick 12 years ago
hi my friend, little back a few since we chatted. company not bad.

👍️0
mick mick 12 years ago
some rich blood here...interesting.
👍️0
flemsnopes flemsnopes 12 years ago
Here is a purported discussion about an unapproved trial with bexarotene, ostensibly by the family of an Alzheimer's patient who already has significantly advanced symptoms. Of course, no one should draw any conclusions from such an unscientific trial, but I suspect this type of activity will be happening with increased frequency, given the hopeless state of conventional treatments and the inevitable progression of the disease. Too bad the FDA is so bureaucratic and elitist it will likely do everything in its considerable power to block expeditious compassionate trials. I hope they prove me wrong, but I don't plan to hold my breath.

Hi All![br>I know you are all anxious for an update. DON'T worry.. I have no intentions of forgetting about you! Presently we are giving my mother 2 pills a day. Each pill as I mentioned above is 75mg. It has been 8 days since we increased her from 1 pill a day to 2 pills a day. Unfortunately myself and my children have been sick and because of my Mother's low immune system I haven't had her at my house this past week, until today. So I have had to rely on my Father's descriptions on how she is doing. [br>So this past week there were a few things that made my Father and I a bit hopeful. One morning she made coffee without instruction (my father said the coffee was bad, but she made it), she also made scrambled eggs for herself without instruction. These are not things she does normally. She also called me on the phone- she had to ask my father for my phone # and she actually hung up after only 2 rings but I can't remember the last time she called me- so that peaked my interest. As I said, she is at my house now and about an hour ago I told her I was going out for dinner later on. Then just a few minutes ago she remembered that I had plans to go out tonight. All of these things are giving me some hope. [br>[br>At the start of this process I asked her to draw a picture of a clock with the hands at 10 past 11 o'clock (found this test on an AD website). She drew a circle and from the middle of the circle she drew out 12 lines. I guess her brain was telling her that there was 12 of something but she couldn't place the numbers. Last week I had her draw it again. She drew almost the same clock- but this time added something... she actually wrote the words"10 minutes past 11 o'clock" inside the clock. To me it seemed like a bit of an improvement because she completed 2 parts- the circle and the time. Although it was wrong- she remembered a second step. [br>[br>Overall though, she is still very confused.
Next week my Mother will be with me so I will be able to have a better description of her status for you."
👍️0
flemsnopes flemsnopes 12 years ago
Nice dividend! (Check your brokerage account tomorrow)

ESALY announced a final cash dividend of 1.005783 with a record date of 3-29-2012. ESALY will not be quoted ex-dividend.

May 25, 2012
OTC Disclosure & News Service

New York, NY -

ESALY – Eisai Co Ltd American Depositary Shares - announced a final cash dividend of 1.005783 with a record date of 3/29/2012. The pay date for this dividend is 6/1/2012.

Additional Comments: Refer to Daily List of 2/29/2012: Amount & Pay Date Established. Gross less 7%; no fee; net=0.931878. Will not be quoted Ex.

Note: The above information was disseminated to OTC Markets Group by FINRA

The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.

http://www.otcmarkets.com/stock/ESALY/news/ESALY-announced-a-final-cash-dividend-of-1.005783-with-a-record-date-of-3-29-2012.-ESALY-will-not-be-quoted-ex-dividend.?id=48067&b=y
👍️0
umiak umiak 12 years ago
VERY interesting, thanks for sharing that site. Found this little mention on the phase 1 study. I am sure they changed there phone number, just kidding.

http://gel-server1.cwru.edu/
👍️0
flemsnopes flemsnopes 12 years ago
Bexarotene Alzheimer's study discussion link. Specifics start at about 18 minutes in.
http://www.prx.org/pieces/75327
👍️0
flemsnopes flemsnopes 12 years ago
Novartis has a co-promotion agreement with Eisai and Co. Ltd (ESALY) in Japan.

Switzerland-based pharmaceutical company, Novartis AG (NVS - Snapshot Report) recently announced positive phase III data from the GLOW 2 study of its pipeline candidate NVA237. The candidate is being studied for the treatment of chronic obstructive pulmonary disease (COPD). The study showed rapid improvement in lung function and symptom relief over one year in COPD patients.

http://www.zacks.com/stock/news/75514/novartis-progresses-with-nva237
👍️0
flemsnopes flemsnopes 12 years ago
Arena Says Obesity Drug Candidate Receives Positive Vote From FDA Advisory Panel

(RTTNews) - Arena Pharmaceuticals, Inc. (ARNA: News ) and Eisai Inc. (ESALY.PK: News ) said Thursday that lorcaserin, an investigational drug candidate intended for weight management, received positive vote from the US Food and Drug Administration's Advisory Committee. Arena shares soared in after-market trading.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

Jack Lief, Arena's President and CEO, said, "The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity. We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application."

Lorcaserin is intended for managing weight, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition.

The drug candidate is a new chemical entity, believed to act as a selective serotonin 2C receptor agonist.

Arena has patents covering lorcaserin in jurisdictions such as the U.S. and Europe. In most cases, these patents are capable of continuing into 2023 without taking into account patent term extensions or other exclusivity Arena may obtain.

While advisory committees provide recommendations to the FDA, the agency makes the final decisions. The Prescription Drug User Fee Act date for the lorcaserin New Drug Application resubmission is June 27, which is the target date for the agency to complete its review.


Arena submitted the original NDA for lorcaserin in December 2009, and the agency issued a Complete Response Letter in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011.

Eisai has exclusive rights to market and distribute lorcaserin in the U.S. subject to FDA approval of the lorcaserin NDA. The European Medicines Agency has accepted the lorcaserin marketing authorization application for filing in March 2012.

Arena said separately that it has expanded the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. In addition to the U.S., the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil.

As per the original agreement, Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution, after regulatory approvals in the territories.

http://www.rttnews.com/1883397/arena-says-obesity-drug-candidate-receives-positive-vote-from-fda-advisory-panel.aspx?type=qf
👍️0
flemsnopes flemsnopes 12 years ago
"It's stunning" (Dementia Today)

The mice returned to normal behaviors three days after treatment with bexarotene, which is marketed as Targretin.
“No one, ourselves included, would have ever imagined that any drug would have worked with this speed,” said Gary Landreth, a Case neuroscientist and lead researcher. “It’s stunning.”

http://www.dementiatoday.com/?p=18260
👍️0
flemsnopes flemsnopes 12 years ago
Having the cake and eating it too.
http://www.uspharmacist.com/content/d/pharmacy_law/c/32890/

The manufacturer of bexarotene, Eisai Co., based in Japan, is being a bit vague in its public statements about this potential off-label use of its product. Instead of coming right out and saying that the drug should not be used in humans until further research is performed, its spokesperson was quoted as saying, “It is our policy to not comment on off-label uses of our products. Physicians are able to prescribe products as they see medically necessary.” The company also disavowed any knowledge of the research study published in Science.17

That is a great way for a company to have its cake and eat it too. Companies can say that they do not have any control of how their products are used once they leave their factories, but they will be happy to take the profits from off-label uses if such an occurrence happens. While this may well be an accurate point of view at some time down the road when human-use evidence is collected, from an ethical perspective, the company should be saying this drug has been approved in the U.S. for a very narrow and specific use and should not be used for other purposes at this time. Perhaps that time could come in a relatively short period if clinical trials were opened under the auspices of an FDA Investigational New Drug Application (INDA) with the approval of the Institutional Research Board (IRB) where the research might be conducted.
👍️0
flemsnopes flemsnopes 12 years ago
Interesting perspective on the prospect for quick clinical trials testing bexarotene in the treatment of Alzheimer's.

What does Alzheimer’s breakthrough mean for you
http://www.clevelandjewishnews.com/special_sections/health_beat/article_4cc68368-692d-11e1-9bb5-001871e3ce6c.html
👍️0

Your Recent History

Delayed Upgrade Clock