Home > Boards > Other Markets > Foreign Stock Markets >

PAION AG Aachen (PA8)

PA8 RSS Feed
Add PA8 Price Alert      Hide Sticky   Hide Intro
Moderator: Leff0815
Search This Board: 
Last Post: 10/26/2020 6:42:46 PM - Followers: 1 - Board type: Free - Posts Today: 0

Remimazolam. The new standard in sedation / anesthesia in future?



https://www.paion.com/fileadmin/user_upload/JA2019.pdf



About PAION

PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation,
anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic.
Remimazolam is partnered in multiple territories outside of Europe.

In Japan, remimazolam was approved for general anesthesia in January 2020. In the U.S., a New Drug Application (NDA) for procedural sedation is under review, with a PDUFA date of 5 July 2020.
In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm
filed for market approval for remimazolam in general anesthesia in December 2019.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA)
for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.

 

PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia & critical care by bringing novel products to market to benefit patients, doctors & stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
PAION AG is listed on the Frankfurt Stock Exchange (Prime Standard Regulated Market, ticker symbol PA8, ISIN DE000A0B65S3).

https://www.paion.com/

Licensing details:

Cosmo Pharmaceuticals
In June 2016, PAION and Cosmo Pharmaceuticals announced a license agreement for Remimazolam.
Cosmo was granted the exclusive development, production, and marketing rights to Remimazolam for the U.S. market
in return for making an upfront payment to PAION and undertaking to pay PAION milestone payments and possible future royalties.
-

2 July 2020: 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

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

15 July 2020 U.S. LICENSE AGREEMENT FOR BYFAVOTM (REMIMAZOLAM) BETWEEN PAION AND COSMO ASSIGNED FROM COSMO TO ACACIA
Aachen (Germany), 15 July 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that
PAION, U.S. remimazolam licensee Cosmo Pharmaceuticals NV ("Cosmo") and Acacia Pharma ("Acacia") have agreed to assign the BYFAVOTM (remimazolam) license
agreement signed in 2016 between Cosmo and PAION to Acacia. The terms of the license agreement remain unchanged but will now be between PAION and Acacia,
with Cosmo no longer being a party to the agreement.

Acacia Pharma:
https://acaciapharma.com/about-us


06 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®). Scheduling by DEA represented the final requirement for BYFAVO to be marketed in the US.
“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
.

https://acaciapharma.com/news/2020/10/acacia-pharma-announces-byfavo-remimazolam-its-newly-approved-product-for-procedural-sedation-clears-final-hurdle-on-path-to-commercial-launch-in-the-us




Mundipharma
In December 2017, PAION and Mundipharma announced a license agreement for Remimazolam. Mundipharma was granted the
exclusive development, production, and marketing rights to Remimazolam for the japanese market in return for making an upfront
payment to PAION and undertaking to pay PAION milestone payments and possible future royalties.
-

23 January 2020: Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application (NDA)
for remimazolam (Japan
trademark: Anerem®) in general anesthesia.
https://www.paion.com/fileadmin/user_upload/PAIONA200123EN.pdf

07 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that Mundipharma,
remimazolam licensee for Japan, informed PAION about the successful launch with first commercial product sales of
Anerem(R) (remimazolam) for the use in general anesthesia in Japan.






Hana Pharm
In October 2013, PAION and Hana Pharm announced a license agreement for Remimazolam.
Hana Pharm was granted the exclusive development, production, and marketing rights to Remimazolam for South Korea in return for making an
upfront payment to PAION and undertaking to pay PAION milestone payments and possible future royalties. In January 2020, PAION and Hana Pharm
announce that they have extended their license agreement for remimazolam to include Southeast Asia (Indonesia, Malaysia, Philippines, Singapore,
Thailand, Vietnam), and Hana Pharm will manage the development and marketing approval process.
Hana Pharm entered into an exclusive remimazolam license agreement for South Korea in 2013.




Pendopharm
In July 2014, PAION and Pendopharm announced a license agreement for Remimazolam. Pendopharm was granted the exclusive development and
marketing rights to Remimazolam for Canada in return for undertaking to pay PAION milestone payments and possible future royalties.




R Pharm
In October  and November 2013, PAION and R Pharm announced a license agreement for Remimazolam. R Pharm was granted the exclusive development,
production, and marketing rights to Remimazolam for Russia (CIS) (october)  Turkey and the MENA region (Middle East and North Africa) (november) in return for
making an upfront payment to PAION and undertaking to pay PAION milestone payments and royalties.




Yichang Humanwell Pharmaceutical Co.
In July 2012, PAION and Yichang Humanwell announced a license agreement for Remimazolam. Yichang Humanwell was granted the exclusive development,
production, and marketing rights to Remimazolam for the Chinese market in return for making an upfront payment to PAION and
undertaking to pay PAION milestone payments and possible future royalties.
-

20 July 2020: YICHANG HUMANWELL RECEIVES MARKET APPROVAL FOR REMIMAZOLAM IN PROCEDURAL SEDATION IN CHINA
https://www.paion.com/fileadmin/user_upload/PAIONA200720EN.pdf

11 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces
that its Chinese remimazolam licensee Yichang Humanwell has recently launched Ruima(R) (remimazolam) in procedural sedation in China.


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

Stock information:

Stock identification number (WKN): A0B65S
ISIN: DE000A0B65S3
Ticker symbol: PA8
Number of shares:  65695942
Market cap (June 5th 2020) ~ 167.500.000 €

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

More info to be found at https://www.paion.com/

PA8
Current Price
Volume:
Bid Ask Day's Range
  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
  • 2Y
  • 3Y
  • 5Y
PostSubject
#49   Remimazolam: Is the Sedative of the Future Here? Leff0815 10/26/20 06:42:46 PM
#48   BYFAVO (Remimazolam) can help to compensate shortages Leff0815 10/06/20 06:13:44 PM
#47   We anticipate the product being available for sale Leff0815 10/06/20 05:20:59 PM
#46   Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Leff0815 10/06/20 02:43:23 PM
#45   Yichang Humanwell has recently launched Ruima(R) (remimazolam) Leff0815 08/11/20 11:20:18 AM
#44   SUCCESSFUL PRODUCT LAUNCH OF ANEREM(R) (REMIMAZOLAM) IN JAPAN! Leff0815 08/10/20 03:07:58 AM
#43   APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM! Leff0815 08/10/20 03:04:17 AM
#42   YICHANG HUMANWELL RECEIVES MARKET APPROVAL FOR REMIMAZOLAM IN Leff0815 07/23/20 05:06:48 PM
#41   U.S. LICENSE AGREEMENT FOR BYFAVO (REMIMAZOLAM) BETWEEN PAION Leff0815 07/15/20 11:54:02 AM
#40   Cosmo Pharmaceuticals announced today that the US Food Leff0815 07/03/20 02:51:01 AM
#39   Yes !!! FDA Approval !!! Leff0815 07/02/20 06:13:44 PM
#38   only one more week.. Leff0815 06/28/20 03:12:07 PM
#37   Approval Japan in January already.. Leff0815 06/14/20 09:57:09 AM
#36   thank you mick 06/09/20 05:24:39 PM
#35   Hi Mick, Leff0815 06/09/20 05:09:53 PM
#34   ecp.yusercontent.com/mail?url=https%3A%2F%2Fwww.edisoninvestmentresearch. mick 06/09/20 11:06:14 AM
#33   does this one trade u.s.a. ????? mick 06/09/20 11:05:32 AM
#32   Director's Dealings CEO James Phillips ! Leff0815 06/08/20 12:26:31 PM
#31   hi girls and boys, submersus 06/07/20 02:08:55 PM
#30   hi girls and boys, submersus 06/07/20 02:07:06 PM
#29   ***PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM Leff0815 06/06/20 11:50:11 AM
#28   newest analysts coverage: Leff0815 06/06/20 11:44:23 AM
#27   PDF on 19 financials and some forecast/outlook for 2020. Leff0815 06/06/20 11:38:28 AM
#26   ** Please pay attention ** Leff0815 06/06/20 11:12:20 AM
#25   https://www.nebenwerte-magazin.com/deutsche-nebenwerte/item/6089-prime-standard- deepdj011 12/30/19 11:45:00 PM
#24   The Next Days over 2,50 € !!! deepdj011 12/30/19 11:43:05 PM
#22   REMIMAZOLAM PHASE III COLONOS Leff0815 10/06/16 05:07:41 PM
#21   Hello gyus, loschek 01/06/15 04:17:35 AM
#20   Echt warst du dort? dann haben wir uns Raphael90 09/19/14 07:17:38 PM
#19   This will test 7€ next week ..... WaVe444 02/16/14 07:38:37 AM
#18   und wie wars ? Fortunato69 02/15/14 03:43:24 AM
#17   Heute bin ich bei Paion in der Hauptverwaltung Packardbell 02/10/14 07:04:23 PM
#16   Are you from Germany ? You will Be Fortunato69 04/19/11 08:22:38 AM
#15   Conference Call - November 22, 2010 rikic 11/22/10 03:45:43 AM
#14   PAION reports positive results of its short acting rikic 11/19/10 10:17:00 AM
#13   I have no US Stocks in my portfolio, erbse24448 11/16/10 11:29:18 AM
#12   I have not other favourite bio stocks from rikic 11/16/10 10:51:35 AM
#11   Hi rikic, erbse24448 11/16/10 10:05:51 AM
#10   Hi Erbse, rikic 11/16/10 08:37:46 AM
#9   Hi rikic, erbse24448 11/16/10 07:25:10 AM
#8   You are welcome, Erbse. rikic 11/16/10 03:33:28 AM
#7   Hallo rikic erbse24448 11/11/10 11:13:39 AM
#6   PA8 is today's Trade Alert with +500% potential! rikic 11/11/10 06:18:18 AM
#5   Get ready for results Phase IIb - Remimazolam rikic 11/10/10 11:55:32 AM
#4   RESULTS BY THE END OF THE NOVEMBER 2010. rikic 10/20/10 05:53:00 AM
#3   Paion AG Expands Desmoteplase License Agreement with its rikic 10/18/10 04:34:17 AM
#2   Analyst Presentation at German Equity Forum Fall 2010, rikic 10/13/10 07:18:37 AM
#1   PAION COMPLETES PHASE IIB STUDY WITH SHORT-ACTING rikic 10/13/10 06:33:54 AM
PostSubject
Consent Preferences