WOODCLIFF LAKE, N.J. and
SAN DIEGO, July 14, 2016 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the
Federal Commission for the Protection Against Sanitary Risk
(COFEPRIS) has granted regulatory approval of the chronic weight
management agent VENESPRI® (lorcaserin HCl: U.S.
brand name: BELVIQ®) for commercialization by Eisai
Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico.
VENESPRI is now approved in Mexico as an adjunct to a reduced-calorie diet
and increased physical activity for chronic weight management in
adult patients with a body mass index (BMI) of 30 kg/m2
or greater (obese). Patients with a BMI of 27 kg/m2 or
greater (overweight) with at least one weight-related medical
condition such as high blood pressure, high cholesterol, or type 2
diabetes, are also eligible to be treated with VENESPRI. The
product is expected to become available later this year. In
connection with the approval Arena will receive a $1 million milestone payment.
"Currently more than 70 percent of the Mexican population is
either overweight or obese," said Shaji
Procida, President and Chief Operating Officer, Eisai Inc.
"Without intervention, these numbers are projected to increase.
Eisai remains committed to help address the health care needs of
this patient population."
In addition to Mexico,
lorcaserin HCl is also approved for weight management in
the United States and in
South Korea, where it is marketed
under the name BELVIQ®. Eisai and Ildong Pharmaceutical
Co., Ltd., market and distribute BELVIQ in the United States and South Korea, respectively. Arena manufactures
and supplies the finished commercial product from its facility in
Switzerland.
"We are pleased that the Mexican health authority has approved
VENESPRI as an option for patients who find it difficult to lose
weight through diet and exercise alone," said Craig M. Audet, Ph.D., Senior Vice President of
Operations & Head of Global Regulatory Affairs, Arena
Pharmaceuticals, Inc.
About VENESPRI (lorcaserin HCl) BELVIQ CIV (in
the United States)) for Chronic
Weight Management
VENESPRI is a serotonin 2C
receptor agonist approved as an adjunct to a reduced-calorie diet
and increased physical activity for chronic weight management in
adults who have a body mass index (BMI) of 30 kg/m2 or greater
(obese), or BMI of 27 kg/m2 or greater (overweight) with at least
one weight-related medical condition such as high blood pressure,
high cholesterol, or type 2 diabetes. It is not known if VENESPRI
is safe and effective when taken with other prescription,
over-the-counter, or herbal weight loss products, nor is it known
if VENESPRI changes the risk of heart problems or stroke, or death
due to heart problems or stroke. The safety and efficacy of
coadministration of VENESPRI with other products intended for
weight loss, including prescription drugs (e.g., phentermine),
over-the-counter drugs and herbal preparations have not been
established. The effect of VENESPRI on cardiovascular
morbidity and mortality has not been established.
For more information about VENESPRI and BELVIQ in the United States, click here for the full
Product Information or visit www.BELVIQ.com.
Important Safety Information for VENESPRI®
(marketed as BELVIQ® in U.S.)
- Pregnancy: Do not take VENESPRI if you are pregnant
or planning to become pregnant, as weight loss offers no potential
benefit during pregnancy and VENESPRI may harm your unborn
baby.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions: Before using VENESPRI, tell your
doctor about all the medicines you take, especially medicines that
treat depression, migraines, mental problems, or the common cold.
These medicines may cause serious or life-threatening side effects
if taken with VENESPRI. Call your doctor right away if you
experience agitation, hallucinations, confusion, or other changes
in mental status; coordination problems; uncontrolled muscle
spasms; muscle twitching; restlessness; racing or fast heartbeat;
high or low blood pressure; sweating; fever; nausea; vomiting;
diarrhea; or stiff muscles.
- Valvular heart disease: Some people taking
medicines like VENESPRI have had heart valve problems. Call your
doctor right away if you experience trouble breathing; swelling of
the arms, legs, ankles, or feet; dizziness, fatigue, or weakness
that will not go away; or fast or irregular heartbeat. Before
taking VENESPRI, tell your doctor if you have or have had heart
problems.
- Changes in attention or memory: VENESPRI may slow
your thinking. You should not drive a car or operate heavy
equipment until you know how VENESPRI affects you.
- Mental problems: Taking too much VENESPRI may cause
hallucinations, a feeling of being high or in a very good mood, or
feelings of standing outside your body.
- Depression or thoughts of suicide: Call your doctor
right away if you notice any mental changes, especially sudden
changes in your mood, behaviors, thoughts, or feelings, or if you
have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause low blood
sugar in people taking medicines for type 2 diabetes, such as
insulin or sulfonylureas. Blood sugar levels should be checked
before and while taking VENESPRI. Changes to diabetes medication
may be needed if low blood sugar develops.
- Painful erections: If you have an erection lasting
more than 4 hours while on VENESPRI, stop taking VENESPRI and call
your doctor or go to the nearest emergency room right away.
- Slow heartbeat: VENESPRI may cause your heart to
beat slower.
- Decreases in blood cell count: VENESPRI may cause
your red and white blood cell counts to decrease.
- Increase in prolactin: VENESPRI may increase the
amount of a hormone called prolactin. Tell your doctor if your
breasts begin to make milk or a milky fluid, or if you are a male
and your breasts increase in size.
- Most common side effects in patients without
diabetes: Headache, dizziness, fatigue, nausea, dry mouth,
and constipation.
- Most common side effects in patients with
diabetes: Low blood sugar, headache, back pain, cough, and
fatigue.
- Nursing: VENESPRI should not be taken while
breastfeeding.
- Drug interactions: Before taking VENESPRI, tell
your doctor if you take medicines for depression, migraines, or
other medical conditions, such as: triptans; medicines used to
treat mood, anxiety, psychotic or thought disorders, including
tricyclics, lithium, selective serotonin reuptake inhibitors,
selective serotonin-norepinephrine reuptake inhibitors, monoamine
oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an
antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC)
common cold/cough medicine); OTC supplements such as tryptophan or
St. John's Wort; or erectile dysfunction medicines.
About Eisai Laboratorios S. de R.L. de C.V. (Eisai
Mexico)
Eisai established Eisai Laboratorios, S. de R.L. de
C.V. (Eisai Mexico) in August 2011 in
Mexico City as a direct subsidiary
of Eisai's U.S. subsidiary Eisai Inc. Mexico is ranked as the fifth largest
pharmaceutical market in the Americas behind the United States, Canada, Brazil and Venezuela and the 16th largest in the
world.
About Eisai Inc.
At Eisai Inc., human health
care is our goal. We give our first thoughts to patients and
their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force
behind our efforts to discover and develop innovative therapies to
help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that
operates in two global business groups: oncology and neurology
(dementia-related diseases and neurodegenerative diseases). Each
group functions as an end-to-end global business with discovery,
development, manufacturing and marketing capabilities. Our U.S.
headquarters, commercial and clinical development organizations are
located in New Jersey; our
discovery labs are in Massachusetts and Pennsylvania; and our global demand chain
organization resides in Maryland
and North Carolina. To learn more
about Eisai Inc., please visit us at www.eisai.com/US.
About Arena Pharmaceuticals
We are a biopharmaceutical
company focused on discovering and developing novel, small molecule
drugs. We are currently directing our activities and resources
primarily on the following activities:
- Advancing our proprietary clinical programs:
- Etrasimod (APD334) – a next generation, highly specific
modulator of Sphingosine 1-Phosphate Subtype 1 (S1P1)
receptor – in an ongoing Phase 2 clinical trial for ulcerative
colitis, and potentially exploring additional indications,
including beyond inflammatory bowel disease
- Ralinepag (APD811) – an agonist of the prostacyclin receptor –
in an ongoing Phase 2 clinical trial for pulmonary arterial
hypertension (PAH)
- APD371 – an agonist of the cannabinoid-2 (CB2)
receptor – most recently completed a Phase 1 multiple-ascending
dose clinical trial with favorable results, and is under evaluation
for pain indications
- Supporting our collaborations:
- Eisai Inc. and Eisai Co., Ltd. and others – in their
efforts with respect to the approved product BELVIQ for weight
management
- Axovant Sciences Ltd. – in Phase 2 clinical trials for
nelotanserin, an inverse agonist of the serotonin 2A receptor for
central nervous system disorders
- Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial
for temanogrel, an inverse agonist of the serotonin 2A receptor for
thrombotic diseases
- Boehringer Ingelheim International GmbH – in preclinical
development of drug candidates targeting a central nervous system
(CNS) receptor for psychiatric diseases
Our US operations are located in San
Diego, California, and our operations outside of
the United States, including our
commercial manufacturing facility, are located in Zofingen,
Switzerland. For more information,
visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
VENESPRI® and BELVIQ® are
registered trademarks of Arena Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. Such forward-looking statements include
statements about the expected commercialization of VENESPRI; the
achievement of a milestone; Eisai's commitment; Arena's focus,
plans and strategy; the advancement and potential of Arena's
clinical programs and collaborations; and activities with Eisai and
other collaborators. For such statements, Arena claims the
protection of the Private Securities Litigation Reform Act of 1995.
Actual events or results may differ materially from Arena's
expectations. Factors that could cause actual results to differ
materially from the forward-looking statements include, but are not
limited to, the following: risks related to commercializing and
developing drugs; the risk that we may need additional funds to
advance all of our programs, and you and others may not agree with
the manner we allocate our resources; cash and revenues generated
from BELVIQ, including the impact of competition; the risk that
Arena's revenues are based in part on estimates, judgment and
accounting policies, and incorrect estimates or disagreement
regarding estimates or accounting policies may result in changes to
Arena's guidance or previously reported results; the timing and
outcome of regulatory review is uncertain, and lorcaserin may not
be approved for marketing in a different formulation or in any
other territory; regulatory decisions in one territory may impact
other regulatory decisions and Arena's business prospects;
government and commercial reimbursement and pricing decisions;
risks related to relying on collaborative arrangements; the timing
and receipt of payments and fees, if any, from collaborators; the
entry into or modification or termination of collaborative
arrangements; unexpected or unfavorable new data; nonclinical and
clinical data is voluminous and detailed, and regulatory agencies
may interpret or weigh the importance of data differently and reach
different conclusions than Arena or others, request additional
information, have additional recommendations or change their
guidance or requirements before or after approval; data and other
information related to any of Arena's research and development may
not meet regulatory requirements or otherwise be sufficient for (or
Arena or a collaborator may not pursue) further research and
development, regulatory review or approval or continued marketing;
Arena's and third parties' intellectual property rights; the
timing, success and cost of Arena's research and development and
related strategy and decisions; results of clinical trials and
other studies are subject to different interpretations and may not
be predictive of future results; clinical trials and other studies
may not proceed at the time or in the manner expected or at all;
having adequate funds; and satisfactory resolution of litigation or
other disagreements with others. Additional factors that could
cause actual results to differ materially from those stated or
implied by Arena's forward-looking statements are disclosed in
Arena's filings with the Securities and Exchange Commission. These
forward-looking statements represent Arena's judgment as of the
time of this release. Arena disclaims any intent or obligation to
update these forward-looking statements, other than as may be
required under applicable law.
Contacts: Eisai
Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Ivor
Macleod
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Laurie
Landau
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Ivor_Macleod@eisai.com
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Laurie_Landau@eisai.com
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201-746-2660
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201-746-2510
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Contact: Arena
Pharmaceuticals, Inc.
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Kevin R. Lind, Chief
Financial Officer
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klind@arenapharm.com
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858-453-7200, ext.
1716
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Eisai Inc.