Agreement marks significant milestone for two of the 29 ANDAs acquired by CASI from Sandoz in January 2018
| ROCKVILLE, Md., June 21, 2018 /PRNewswire/ -- CASI Pharmaceuticals Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces a strategic and long-term manufacturing agreement with Yiling Wanzhou International Pharmaceutical Co., Ltd. for the manufacturing of entecavir and cilostazol. Yiling Wanzhou International Pharmaceutical Co., Ltd. is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd. The contracted manufacturing facilities have been inspected by both the U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and operate to strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Manufacturing Practice (GMP) standards, which will enable CASI to eventually sell both entecavir and cilostazol in the U.S., China and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that CASI acquired from Sandoz in January 2018. Ken K. Ren, Ph.D., CASI’s Chief Executive Officer stated, “We are very pleased to partner with Yiling Wanzhou International as our manufacturing site for entecavir and cilostazol. Through this partnership, we will leverage Yiling’s manufacturing knowledge and capabilities in order to provide high quality, cost-effective medicines that are critically needed for patients both in China and the U.S.” Dr. Ren continued, “This partnership further supports the overarching vision of CASI to bring much needed medicines from the U.S. into China as well as cost-effective drugs from China to the U.S. This would also be the first step for CASI to execute on our overall development plan for the acquired ANDAs with additional development activities and partnering discussions underway.” The FDA approved entecavir in 2005 for the treatment of chronic hepatitis B viral (HBV) infection.1 Entecavir is an HBV nucleoside analog reverse transcription inhibitor that interferes with HBV replication. There are over 100 million HBV carriers in China with approximately 20 million people with chronic HBV infection. The 2016 estimated sales in China for entecavir were approximately $1.5 billion USD, which accounted for approximately 20-percent of the patients with chronic HBV receiving entecavir treatment. The FDA approved cilostazol in 2006 for the reduction of symptoms of intermittent claudication.2 Cilostazol is a PDE-III inhibitor. Cilostazol inhibits platelet aggregation, improves endothelial cell function, and acts as a vasodilator enabling blood to move more easily through peripheral blood vessels. The 2016 estimated sales in China for cilostazol were approximately $65 million USD. About CASI Pharmaceuticals, Inc. CASI Pharmaceuticals (NASDAQ: CASI) is a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world. CASI’s product pipeline features three U.S. Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights. These are currently in various stages in the regulatory process for market approval in China. The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that are pending FDA approval. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com. Forward Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of ANDAs; our inability to predict when or if our product candidates will be approved for marketing by CFDA authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. EVOMELA®, MARQIBO®, and ZEVALIN® are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates. 1. See https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206672 for the full U.S. Entecavir prescribing information 2. See https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077310 and https:// www.accessdata.fda.gov/Scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077021 for the full U.S. Cilostazol prescribing information
COMPANY CONTACT: INVESTOR CONTACT: MEDIA CONTACT: CASI Pharmaceuticals, Inc. Solebury Trout PressComm PR, LLC 240.864.2643 Jennifer Porcelli Juliette Bogus ir@casipharmaceuticals.com 646.378.2962 410.980-5687 jporcelli@troutgroup.com juliettebogus@presscommpr.com Brennan Doyle 617.221.9005 BDoyle@troutgroup.com --- ---------------------
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Company Codes: NASDAQ-SMALL:CASI |
