Based on the terms of the agreement, CrystalGenomics will supply finished product of Acelex to PharmArtis and PharmArtis will be responsible for registration study required for Russian approval, marketing and distribution in Russia. The term of the agreement will be for 10 years following launch.
The total value of the agreement is worth up to USD 105,740,000 (approximately KRW 119,500,000,000). In addition to profit from transfer of finished product, CrystalGenomics will be eligible to receive USD 67.4 million in milestone payments based on the sales volume of Acelex in Russia.
CrystalGenomics spokesperson stated, This export agreement is our third Acelex export agreement following agreements with Turkeys TRPharm and Brazils Apsen, and also, Acelex will start to serve as a real cash cow for CrystalGenomics as we anticipate revenues coming in from sales of Acelex overseas, beginning next year.
Acelex is next generation osteoarthritis therapeutic that selectively inhibits COX-2 enzyme which causes pain and inflammation. It is a tissue selective COX-2 inhibitor. Even with only 2mg per day, Acelex can deliver superb efficacy with a good safety profile and, it is Koreas 22nd (1st by a biotech venture) novel drug that was approved in 2015 and commercialized in Korea through Dong-A ST and Daewoong Pharma.
PharmArtis is a Russian Pharmaceutical company that specializes in innovative drugs and a subsidiary of BIONIKA Group, a well-known group within the Russian Pharmaceutical industry.
The population of Russia is approximately 145 million people and the Russian pharmaceutical market in 2017 exceeded USD 20 billion where 63% of this came from imported drugs. There are more than 65,000 pharmacies throughout Russia and they operate in 7 federal districts of the country. Russia annually consumes more than 365 million units of NSAIDs drugs worth about 50 billion rubles (USD 762 million). The highest growth within the NSAIDs market came from the segment of M 01 AH Coxibs with CAGR of more than 30% [Data source: AlphaRM (www.alpharm.ru)]. Since the focus of PharmArtis is in the NSAID segment, it is anticipated that there will be a fast market uptake following the launch of Acelex in Russia.
Dr. Joong Myung Cho, the CEO of CrystalGenomics, stated, This export agreement was made possible due to the recognition of excellent efficacy and competitiveness of Acelex, and we plan to closely collaborate with PharmArtis in order to spread sales of Acelex throughout entire Russia. The CEO also said, We plan to negotiate with other potential partners more actively so that Acelex can enter the global market more quickly.
Meanwhile, CrystalGenomics had signed an export agreement with TRPharm in 2016 for 19 countries covering Turkey and MENA region, with Apsen for the Brazilian market in September of this year, and currently in the process of registering the product in each country.
About Acelex® (polmacoxib)
Acelex is a novel once-a-day osteoarthritis drug approved and available in South Korea. The commercialization rights of Acelex for Turkey and the MENA region was licensed to TR-Pharm and is pending approval in several key markets such as Turkey, Saudi Arabia, and the UAE, and additional regulatory filings are expected to be made in other countries over the course of the next few years.
About CrystalGenomics
CrystalGenomics, is a commercial stage biopharmaceutical company focused in structure-based drug discovery, development, and commercialization of novel therapeutics in unmet medical need areas of inflammation, oncology, and infectious disease. The Company has recently added manufacturing and commercialization capabilities through multiple acquisitions. For more information, please visit: www.crystalgenomics.com. CrystalGenomics is listed on KOSDAQ (083790).
About PharmArtis International
PharmArtis International is a Russian pharmaceutical company that applies best practices and innovations, as well as scientific, production and financial resources to expand opportunities, to maintain and improve health and quality of life. PharmArtis Int. creates and manages a portfolio of innovative medicines. PharmArtis Int. is affiliated with the well-known in Russia BIONIKA Group of companies, which has unique competencies in the medical and pharmaceutical industries. For more information, please visit: www.bionika.ru
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