PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION

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PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS


link

PAION ANNOUNCES EXCLUSIVE LICENSING AGREEMENT WITH LA JOLLA PHARMACEUTICAL FOR GIAPREZA(TM) (ANGIOTENSIN II) AND XERAVA(TM) (ERAVACYCLINE) IN EUROPE

link

PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO) IN GENERAL ANESTHESIA IN SOUTH KOREA

Read more

link

These advantages make remazolam very likely to replace propofol in painless gastroscopic anesthesia.

clinicaltrials.gov

US Sales starting!

link

Stock still low.

Remimazolam: Is the Sedative of the Future Here?


link


Dr. Sorooshian: We believe BYFAVO will become a key component in sedation and anesthesia practice. The encouraging safety profile of BYFAVO, even in patients with ASA Physical Status scores of III and IV, should make it appropriate in a wide variety of settings and patient populations.

BYFAVO (Remimazolam) can help to compensate shortages
of PROPOFOL and MIDAZOLAM !
Check shortages yourself.
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

We anticipate the product being available for sale in the US prior to the end of the year.
(Mike Bolinder, Acacia Pharma’s CEO. )

Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Product for Procedural Sedation, Clears Final Hurdle on Path to Commercial Launch in the US

·BYFAVO expected to be commercially available in the US before the end of the year

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

Cambridge, UK and Indianapolis, US – 6 October 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, today announced that the US Drug Enforcement Administration (DEA) has designated its procedural sedative BYFAVO™ (remimazolam injection) as a Schedule IV medicine. This designation is the schedule for drugs with a low potential for abuse and low risk of dependence and is consistent with that granted to many other benzodiazepine drugs, including midazolam and diazepam (Valium®).

BYFAVO received approval from the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Scheduling by DEA represents the final requirement for BYFAVO to be marketed in the US, with launch expected by the end of 2020.

“We are grateful to DEA for its timely determination of the scheduling of BYFAVO and are excited to bring this novel product to the US market,” commented Mike Bolinder, Acacia Pharma’s CEO. “We will start the process of labeling and packaging our stock of commercial product immediately so that we can make BYFAVO available to patients as soon as possible. We anticipate the product being available for sale in the US prior to the end of the year. Our first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales. We are delighted to be able to provide these two medicines to physicians and their patients in the United States.”

Contacts
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
IR@acaciapharma.com

International Media
Mark Swallow, Frazer Hall, David Dible
Citigate Dewe Rogerson
+44 20 7638 9571
acaciapharma@citigatedewerogerson.com
US Investors
LifeSci Advisors
Irina Koffler
+1 917-734-7387
ikoffler@lifesciadvisors.com Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31
chrisvanraemdonck@telenet.be

About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.

Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) is available in the US for the management of postoperative nausea & vomiting (PONV).

BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion UK Limited for the US market.

APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.

Acacia Pharma has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

www.acaciapharma.com

About BYFAVO™

BYFAVO (remimazolam) for injection is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less, such as during colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the US, of which around 90% use moderate sedation.

Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to registration. BYFAVO is now approved in the US and is indicated for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less.

Yichang Humanwell has recently launched Ruima(R) (remimazolam)
in procedural sedation in China.

SUCCESSFUL PRODUCT LAUNCH OF ANEREM(R) (REMIMAZOLAM) IN JAPAN!

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are very pleased to hear that after the recent launch in Japan our partner has now made their first commercial sales, and product listing in multiple University & General Hospitals. PAION is eligible to royalties between 16-18% in Japan. This news is the first demonstration of a positive market response to the launch of remimazolam, and we look forward to sharing further commercial news when we receive it regarding the Japanese market."

link

APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM!

"PAION was contacted by the Belgian regulatory authority as to whether remimazolam could be delivered nationwide because of the current shortages of propofol and midazolam due to the coronavirus pandemic. "


link

YICHANG HUMANWELL RECEIVES MARKET APPROVAL FOR REMIMAZOLAM IN PROCEDURAL SEDATION IN CHINA


The third marketing approval of remimazolam and the second in procedural sedation is a major milestone on the path to bringing this novel anesthetic to patients around the world, and we both congratulate Yichang Humanwell on this achievement, and await their confirmation of the marketing approval”, Dr. Jim Phillips, CEO of PAION AG, commented. “We anticipate the roll-out of remimazolam in China still in the second half of 2020.”

reference

U.S. LICENSE AGREEMENT FOR BYFAVO (REMIMAZOLAM) BETWEEN PAION AND COSMO ASSIGNED FROM COSMO TO ACACIA

So Acacia is direct license partner to Paion. Which keeps costs down, and reaction to market developments much faster.

link to PDF

Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved BYFAVO TM (remimazolam injection) for the induction and maintenance of procedural sedation.

link

Yes !!! FDA Approval !!!

https://www.cosmopharma.com/news-and-media/press-releases-and-company-news/2020/200702


first major step is done...

to be continued...

only one more week..

FDA decision on Remimazolam getting closer!

Approval Japan in January already..

Just edited the intro-page.
almost forgot about that one

thank you

Hi Mick,

unfortunately no direct listing in USA.
Only way would be through OTC / Others.

Should be ticker symbol PAIOF

Maybe you can check up on that, and drop information here.

I am german citizen, so i cannot check.

[-chart]ecp.yusercontent.com/mail?url=https%3A%2F%2Fwww.edisoninvestmentresearch.com%2Fresearchreports%2Fcovers%2FDE000A0B65S3Paion090620update-cover.jpg&t=1591714921&ymreqid=c6f2e490-95ab-649b-1ce5-1d0000014e00&sig=lInsHvywm7__.qWXTbHQlA--~C[/chart]

does this one trade u.s.a. ?????

Director's Dealings CEO James Phillips !

https://www.paion.com/medien-und-investoren/newsroom/directors-dealings/

Click 2020 to find newest dealings.

hi girls and boys,

we are and Paion ist still waiting for approval in the next few days from china....
and then the FDA should have contacted us by 05.07 the chances of approvals are very good ..........

The risk of total loss is zero. If you are looking for a possible ten-excavator, you will find it right here. This is my personal opinion. This could be the place where the course explodes every hour. The risk downwards is limited even if the US approval should be postponed again this time for whatever reason (which I can't imagine). In South Korea a factory was built for the production.

paion "buy" | wallstreet-online.de - Full discussion under:
https://www.wallstreet-online.de/diskussion/992863-neustebeitraege/paion-buy

Translated with www.DeepL.com/Translator (free version)

hi girls and boys,

we are waiting for approval in the next few days from china....
and then the FDA should have contacted us by 05.07 the chances of approvals are very good ..........

The risk of total loss is zero. If you are looking for a possible ten-excavator, you will find it right here. This is my personal opinion. This could be the place where the course explodes every hour. The risk downwards is limited even if the US approval should be postponed again this time for whatever reason (which I can't imagine). In South Korea a factory was built for the production.

paion "buy" | wallstreet-online.de - Full discussion under:
https://www.wallstreet-online.de/diskussion/992863-neustebeitraege/paion-buy

Translated with www.DeepL.com/Translator (free version)

***PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL***

PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred. PAION will fulfill the request from the hospital and will deliver the material free of charge.

Dr. Phillips (CEO of PAION AG) commented: “We are pleased to be able to help San Raffaele during the current Covid-19 crisis, and to be able to contribute to the global fight against the pandemic.”


link

newest analysts coverage:

link

PDF on 19 financials and some forecast/outlook for 2020.
released 03/26/2020

PDF

** Please pay attention **

FDA decision on Remimazolam getting closer!

Application for procedural sedation.
Paion and U.S. licensee Cosmo Pharmaceuticals awaiting
news from FDA shortly.

PDUFA decision date of 05 July 2020.

Stock slowly rising already...
Marketcap still low Though...

https://www.nebenwerte-magazin.com/deutsche-nebenwerte/item/6089-prime-standard-paion-ag-weltweit-im-plan,-heute-südkorea-eingereicht

The Next Days over 2,50 € !!!

REMIMAZOLAM PHASE III COLONOS
COPY DATA TO BE PRESENTED
AT THE AMERICAN COLLEGE OF GASTROENTEROLOGY 2016
MEETING
•
Phase III colonoscopy study data accepted as a late breaker
•
Primary investigator Prof. Douglas Rex will present study data
on Tuesday, 18 October 2016
Aachen, 22 September 2016 – PAION AG, a specialty pharma company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces
today that an oral presentation on the clinical results of remimazolam’s U.S.
Phase III colonoscopy trial has been accepted for the ACG meeting.
Remimazolam is an innovative, ultra-short acting anesthetic/sedative for which
positive headline data from this trial were published in June 2016.
Prof. Douglas Rex, M.D., Indiana University, Indianapolis, U.S., primary
investigator of this Phase III trial, will present the data in the Colon/Stomach
oral session that runs from 2:15 - 3:45 pm PDT (11:15 pm – 0:45 am CEST)
on 18 October 2016 at ACG in Las Vegas. The title of the abstract is:
“
Remimazolam is a safe and effective agent for sedation in outpatient
colonoscopy: Results of a phase 3, multi-center, randomized, placebo
controlled trial.
”
PAION will be available for discussions at Medical Information booth 1322 in
the exhibition hall.
Prof. Douglas Rex, M.D., commented: “ The acceptance of the study results as
a late breaker underscores the landmark status of the remimazolam Phase III
study in patients undergoing colonoscopy. I look forward to discuss these
important data with my fellow gastroenterologists .”

Dr. Wolfgang Söhngen, CEO of PAION AG, commented:
“We are proud that after eight years of work on remimazolam the data of the first Phase III
performed by PAION were accepted as a late breaker. Scientific presentations
of this successful pivotal trial are important activities to prepare the market
together with our U.S. licensing partner Cosmo Pharmaceuticals (Cosmo).
”
In addition to the detailed analysis of the primary endpoint of
the Phase III trial (comparison to placebo) also data comparing remimazolam to the
open label arm with gold standard midazolam will be presented, and relevant safety, efficacy and efficiency parameters will be addressed.

Link:
http://www.paion.com/uploads/tx_news/PAIONP162209en.pdf

Hello gyus,
Anybody know Paion.
Puls Check

Echt warst du dort? dann haben wir uns vll schon gesehen

This will test 7€ next week .....

und wie wars ?

Heute bin ich bei Paion in der Hauptverwaltung da werde ich mal sehen was ich da an Info so abstauben kann

Are you from Germany ? You will Be the First Person that i can read in a international Board !

Gerald

Conference Call - November 22, 2010

PAION will hold a conference call today, Monday, 22 November 2010 at
10 a.m. CET (9 a.m. GMT, 4 a.m. ET) for media representatives and
shareholders in German. PAION will also be available for analysts and
investors in a further conference call in English at 4 p.m. CET.
PAION will host the conference calls to present details on the headline data of
the Phase IIb study with Remimazolam.
To access the call, please dial:
Germany +49 (0) 69 710445598
UK +44 (0) 20 3003 2666
US + 1 866 966 5335
(other countries: please choose from D/UK/US numbers).
The participant pass code is “PAION”.
To allow for smooth processing we suggest that you dial in ten minutes before
the beginning of the call.
The conference call will be supplemented by a webcast presentation which
can be accessed during the call under the following link:
www.meetingzone.com/presenter/
For the call at 10 a.m. CET, please use the PIN 1961272.
For the call at 4 p.m. CET, please use the PIN 4349347.
The dial-in details for the conference call and the webcast link are also
available on PAION’s website http://www.paion.com
The conference call will be recorded. Details on how to access the replay will
be posted on the same web page after the call.

PAION reports positive results of its short acting anaesthetic/sedative Remimazolam (CNS 7056) in a Phase IIb study

http://www.paion.de/images/stories/investoren/finanznachrichten/2010/en/paiona101119en.pdf

I have no US Stocks in my portfolio, because my english is not good enough.

I have selected some German biotechs for you with a time frame from 2-5 years with a big potential.

1. Paion
2. Morphosys
3. Evotec
4. 4SC AG
5. Wilex
6. VITA 34

This german biotech are highest risk with little money, some with a good potential by success. They are very risky, because they have no partner

1. Mologen
2. Cytotools
3. Biofrontera

All the others german biotechs are not so good. I have they only on the watchlist

Have a nice day
Erbse

I have not other favourite bio stocks from Germany at present.
Look at my some favourite stocks in my profile.
I can order in USA, Germany ...

Hi rikic,
yes thats my nickname at the Ariva Board.

What are your favourite stocks from the german biotechs. Can you order at FSE or XETRA.
I also look for biotechs with a time frame till 5-6 years or longer. In german there are not so many good biotechs with enough money. The most biotech stocks are very risky.

Hi Erbse,

Thank you for your info.

I am from Middle Europe. I have accumulated a PAIONs shares already. I hold and wait untill announcement of Remimazolam Phase IIb trial results. I believe they will be positive again ;)

The board with your nick "gurke24448" is also here
http://www.ariva.de/paion-aktie
Or not?

P.S. I am looking for undervalued stocks (especially biostocks with very good pipeline) with high potential within 1-3 years.

Good luck!

Hi rikic,

Paion presents at the Eigenkapitalforum in Frankfurt


PAION AG DE000A0B65S3 Dienstag, 23.11.2010 08:15-09:00 Room Madrid

I think, we get the Remimazolam results at this day or one day before, when the Conference started.
From where do you come. My home is also in Aachen, but i have nothing to do with Paion. Paion is one of mine favourite german biotech stock.
I hope you can understood my bad english. I learned my few Englisch words since about 45 years at my school time. But i never used my english and so it is very bad. I have a little Board withsome Paion facts.

German Erbses Paion Board

Have a nice day
Erbse

You are welcome, Erbse.

Sie sind herzlich wilkommen, Erbse.

Ich warte für Remimazolam ergebnisse bis ende November 2010.

Hallo rikic
Schön, dass einer die Paion Aktie hier bekannt macht. Mein Englisch ist leider viel zu schlecht. Wenn es was wichtiges in Englisch zu kopieren gibt würde ich dir gerne helfen.

Grüße
Erbse

PA8 is today's Trade Alert with +500% potential!

Get ready for results Phase IIb - Remimazolam (CNS 7056).

Headline data expected by end of November 2010.