CASI Pharmaceuticals Announces Launch of EVOMELA® (melphalan for injection) in China

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Aug 12, 2019, 07:00 ET

ROCKVILLE, Md., Aug. 12, 2019 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, announces the product launch of EVOMELA^® (melphalan for injection) in China which is the first commercial product for the Company.

EVOMELA^® received market approval by the China National Medical Products Administration (NMPA) for use as high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplant in patients with multiple myeloma, and as a palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It is the only approved and commercially available melphalan product in China.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer commented, "This is a proud milestone for CASI. We have an established commercial and supply chain infrastructure with hospitals and physicians ready to accommodate the anticipated demand for this vital treatment. The launch of EVOMELA^®officially marks the transition of CASI to a full-scale commercial operation. We look forward to advancing our product line and commercializing additional products from our hematology oncology portfolio, as well as other products where high unmet medical needs exist."

EVOMELA^®, now owned by Acrotech Biopharma LLC., is one of three drugs that were part of a licensing agreement with Spectrum Pharmaceuticals, Inc. which also includes ZEVALIN^® and MARQIBO^®.

About Multiple Myeloma

Multiple myeloma is a malignant hematological disorder that is characterized by abnormal proliferation of clonal plasma cells in the bone marrow and the secretion of monoclonal immunoglobulins that are detectable in the serum or urine. Multiple myeloma accounts for 10-13% of hematological malignancies^1,2 and in Western countries, the estimated incidence is 5.6 cases per 100,000 persons². The estimated incidence of multiple myeloma in China is ~2.0 cases per 100,000 persons³, for an estimated annual incidence of approximately 27,800³. The estimated number of patients in China with multiple myeloma who are candidates for auto-hematopoietic stem cell transplantation is estimated to be approximately 16,900 cases per year. The current number of patients with multiple myeloma who undergo auto-hematopoietic stem cell transplantation in China is estimated to be approximately 800 cases per year. Autologous stem cell transplantation (ASCT) has been demonstrated to improve complete response rates and prolong median overall survival in patients with multiple myeloma^1,3 and is considered standard of care for transplant-eligible patients. The preferred conditioning regimen for ASCT is high dose melphalan 200mg/m², it is the golden standard conditioning treatment.

1.	S. Rajkumar, Mayo Clin Proc. 2016 January; 91(1): 101–119
2.	A. Palumbo, N Engl J Med, 2011; 364: 1046-60
3.	J. Lu, Blood Cancer Journal (2014) 4, e239; doi:10.1038/bcj.2014.55

About CASI Pharmaceuticals

CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world. CASI's product pipeline features (i) an autologous anti-CD19 T-cell therapy investigative product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of hematological malignancies; (iii) three U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs in-licensed from Acrotech Biopharma L.L.C. and its affiliates for which CASI has exclusive rights to the greater China market, consisting of EVOMELA^®(Melphalan for Injection), ZEVALIN^®(Ibritumomab Tiuxetan) and MARQIBO^® (Vincristine Sulfate Liposome Injection); and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs), including entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus. CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China through which our China operations are conducted. 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 difficulty of executing our business strategy in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, NMPA, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks 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; and our dependence on third parties. 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^®, Zevalin^® and Marqibo^®are proprietary to Acrotech Biopharma LLC and its affiliates.