Remimazolam strategy

PAION selectively seeks to enter into development and commercialization collaborations with partners with local expertise or with a specific therapeutic focus with respect to remimazolam. Such collaborations are an effective way of funding and advancing remimazolam’s late-stage development and of assisting PAION with its commercialization in international markets where PAION does not intend to directly conduct sales and marketing activities. PAION expects that the existing collaboration partners will continue the development of remimazolam on the basis of data generated from our U.S., Japanese and European clinical development programs, and subsequently PAION may receive additional data and payments under the existing agreements in the medium to long term. PAION’s ultimate goal is to participate in the worldwide commercialization of remimazolam. In order to exploit remimazolam’s full potential, it is PAION’s defined target to commercialize remimazolam on its own in the EU or certain markets in the EU immediately after a potential market approval. PAION is also well positioned to find further collaboration partners. Pharmaceutical companies have a growing need to add drugs to their pipeline that have already demonstrated proof of concept in advanced stages of clinical trials and also provide a commercially viable alternative in a global healthcare environment characterized by increasing cost consciousness.

Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, South Korea and Japan with Cosmo, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm, and Mundipharma, respectively. For all other markets outside the EU, remimazolam is available for licensing.

All license partners have activities ongoing to support future filings in their respective territories with a focus on clinical studies and regulatory interactions.

In May 2017, PAION’s remimazolam license partner for Canada, Pendopharm, a division of Pharmascience Inc., together with PAION delegates, had a pre-NDS meeting with Health Canada for remimazolam for the indication conscious sedation. Health Canada is the agency responsible for approving drugs in Canada. During the meeting, the main questions raised for discussion following the preliminary assessment of remimazolam by Health Canada were clarified. Health Canada stated in the meeting that the non-clinical and the clinical data package, including the human abuse liability data available at the time, were regarded as adequate for filing. Currently, PAION expects filing for market approval in Canada after the market approval dossier in the U.S. has been filed.

PAION’s Russian remimazolam license partner R-Pharm announced the start of a Phase III study with remimazolam in general anesthesia in Russia in August 2017. Completion of the study is expected still in the first half of 2018. Subsequently, R-Pharm plans filing for market approval which is currently planned end of 2018.

In December 2017, PAION entered into a remimazolam license agreement with Mundipharma in course of which PAION has granted Mundipharma an exclusive license for the development and commercialization of remimazolam in Japan.

Under the terms of the agreement, Mundipharma has the right and obligation to further develop remimazolam in all indications in Japan with PAION’s support. Mundipharma will bear all cost for market authorization and distribution. PAION receives a EUR 1 million upfront payment. PAION is also entitled to receive additional payments totaling up to EUR 25 million depending on the achievement of certain regulatory and commercial milestones in the three indications procedural sedation, general anesthesia and Intensive Care Unit (ICU) sedation. PAION is also entitled to receive tiered royalties starting in the low double-digits to over 20% of net sales, depending on sales levels and sales price (National Health Insurance (NHI) price), which will be determined by the Japanese government.

Based on the positive pre-NDA meeting with the Japanese authority, PAION had started preparations for a market approval dossier for remimazolam. Mundipharma has now taken over these tasks with PAION’s support. Mundipharma currently plans filing for market approval in Japan in 2018.

PAION’s South Korean remimazolam license partner Hana Pharm is going to conduct a Phase III study with remimazolam in general anesthesia in South Korea. Completion of the study is expected in 2018.

PAION’s Chinese remimazolam license partner Yichang Humanwell is going to conduct a Phase II study with remimazolam in general anesthesia and a Phase III study with remimazolam in procedural sedation in China.