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ROCKVILLE, Md., Dec. 5, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China’s Food and Drug Administration (CFDA) has accepted for review the Company’s import drug registration application for EVOMELA® (melphalan) for Injection.
CASI’s China rights to EVOMELA (melphalan) for Injection was previously licensed from its partner Spectrum Pharmaceuticals, Inc. along with two other commercial-stage Spectrum drugs, MARQIBO® and ZEVALIN®. EVOMELA received U.S. FDA approval earlier this year for multiple myeloma patients as a high-dose conditioning treatment prior to autologous stem cell transplantation (ASCT) and as palliative treatment for patients who are not candidates for oral therapy. It was launched in the U.S. this year by Spectrum.
Ken Ren, Ph.D, CASI’s Chief Executive Officer, commented, “Multiple myeloma is the second most common malignancy in blood cancers, often occurring in elderly patients. There were more than 12,000 new cases and more than 9,000 deaths from multiple myeloma in China in 2015. With the aging of China’s population, the number of new cases is rapidly rising. Melphalan is extensively used worldwide in the treatment of multiple myeloma and is the main drug in pre-transplant conditioning therapy. Melphalan, however, is not currently commercially available in China. EVOMELA, an innovative and proprietary new formulation of melphalan, offers significant advantage in that it (i) does not contain propylene glycol which causes significant side effects; (ii) has longer stability; and (iii) is the only intravenous melphalan product approved for use in the high-dose conditioning indication. We look forward to working with the CFDA to advance EVOMELA towards market approval.”
About CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China. CASI’s product pipeline includes exclusive rights to MARQIBO® (vinCRIStine sulfate LIPOSOME injection), EVOMELA® (melphalan) for Injection and ZEVALIN® (ibritumomab tiuxetan) for the greater China market (including Taiwan, Hong Kong and Macau). CASI’s development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. 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 and in the Company’s filings with the U.S. Securities and Exchange Commission.
EVOMELA was approved by FDA based on its bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study via the 505(b)(2) regulatory pathway. EVOMELA has been granted Orphan Drug Designation by the FDA for its use as a high-dose conditioning regimen for patients with multiple myeloma undergoing autologous stem cell transplantation (ASCT). EVOMELA’s melphalan formulation does not contain propylene glycol. The use of the Captisol® technology to reformulate also contributes to the 4 hour admixture stability of EVOMELA at room temperature. This is in addition to the 1 hour stability of reconstituted EVOMELA drug product at room temperature and 24 hour stability at refrigerated temperature (5ºC).
Please see the Important Safety information available at www.evomela.com. EVOMELA is not yet available in China; more information on EVOMELA for countries outside the greater China region is available at www.sppirx.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: 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 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; 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 models are not necessarily indicative of 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.