PAION GRANTS REMIMAZOLAM LICENSE FOR SOUTHEAST ASIA TO HANA PHARM
DGAP-News: PAION AG
/ Key word(s): Contract
- Hana Pharm to extend remimazolam license territory by adding Southeast Asia
- EUR 1.5 million upfront payment
- Up to EUR 4.2 million in future milestone payments
- Low double-digit royalties
Aachen (Germany), 08 January 2020 - The Specialty Pharma Company PAION AG (FSE: PA8) and Hana Pharm, South Korea, today 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.
PAION will receive an upfront payment in the amount of EUR 1.5 million, potential regulatory and commercial milestone payments of up to EUR 4.2 million and low double-digit royalties on net sales in the Territory.
Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We trust the vast experience of our Hana Pharm colleagues to manage these regions to our mutual benefit. We appreciate the great confidence of Hana Pharm in remimazolam and that we will now be involved in this exciting growth region."
Dr. Younha Lee, CEO of Hana Pharm, stated: "We have gained deep knowledge and expertise around remimazolam throughout the last 6 years of clinical and regulatory development in Korea having implemented corporate legacy, "Better Medicine, Better life". This extended agreement of today reaffirms our strong and enduring partnership with PAION and also, our commitment to bring this innovative drug to the patients with high unmet medical need, as early as possible."
PAION has completed clinical development of remimazolam for procedural sedation in the U.S. The U.S. licensee Cosmo submitted a New Drug Application (NDA) in procedural sedation in the U.S. in April 2019 and is responsible for any further development activities in the U.S. In Japan, licensee Mundipharma filed for market approval in general anesthesia in December 2018. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and a Phase III trial in general anesthesia is ongoing.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation beyond 24 hours is another possible attractive indication for further development in the EU by PAION as well as by its licensees in other territories.
Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region (R-Pharm) as well as South Korea and Southeast Asia (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.
About Hana Pharm
611 people are employed in Hana Pharm as of December 2019, and this specialty company is continuously strengthening its product portfolio in the major therapeutic areas such as Pain, Anesthesia, Cardiovascular, Gastrointestinal, Respiratory, CNS and Opthalmology etc.
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. A Phase III trial in general anesthesia is ongoing.
Development for intensive care unit (ICU) sedation is part of the longer-term life-cycle plan for remimazolam.
Hana Pharm Contact:
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
08.01.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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