USBN Q4 2018

US BUSINESS NEWS / Q4 2018 9 , CrystalGenomics, Inc. announced that they have signed an Export Agreement with PharmArtis International for the commercialization of Acelex ® (polmacoxib) in Russia. CrystalGenomics Signs Export Agreement with PharmArtis for Acelex in Russia 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 Turkey’s TRPharm and Brazil’s 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 Korea’s 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.