ROCKVILLE, Md., July 20, 2015 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), 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, announces that ZEVALIN®is now available at hospitals inHong Kong to patients with indicated non-Hodgkin's lymphoma (NHL), including at Hong Kong Sanatorium & Hospital. The drug will be supplied by CASI and its local partner, Global Medical Solutions Hong Kong Limited.
ZEVALIN (ibritumomab tiuxetan) is a FDA-approved product indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). It is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy. ZEVALIN builds on the combined therapeutic effects of a targeted biologic monoclonal antibody augmented with a beta-emitting radioisotope. CASI Pharmaceuticals holds the exclusive marketing rights to ZEVALIN in greater China (including Taiwan, Hong Kong and Macau) and is launching the drug in Hong Kong as the first of its marketing territories.
Rong Chen, M.D., CASI's Chief Medical Officer, commented, "We are very pleased that we can now provide ZEVALIN in Hong Konghospitals and help address the unmet medical needs there. ZEVALIN is clinically proven to have significantly higher complete response rate (CR) and overall response rate (ORR) in relapsed or refractory, low-grade or follicular B-cell NHL patients in comparison with rituximab. It is also clinically proven to be efficacious with quite high CR and ORR in patients who are not responding or relapsed from rituximab therapy.
"We are very excited to work with Hong Kong Sanatorium & Hospital to make ZEVALIN available to patients," said Ken K. Ren, Ph.D., Chief Executive Officer of CASI Pharmaceuticals. "It is one of the leading private hospitals in Hong Kong known for its high quality of patient care based on advanced knowledge, expertise and technology in the healthcare field. Although Hong Kong is a relatively small market, it is strategically important as it will enable us to gain clinical knowledge and experience for ZEVALIN in a Chinese patient population, which we believe will have positive impact in market penetration when ZEVALIN is approved and becomes available in our greater China markets."
Dr. Ren continued, "CASI is on track to file its import drug registration application for ZEVALIN with the Chinese FDA by the third quarter of this year, followed by the filing of its marketing application and initiation of commercial activities for ZEVALIN in Taiwan. In addition to ZEVALIN, the Company has exclusive marketing rights in greater China to MARQIBO® and EVOMELA™ (CE-Melphalan HCl) for injection both also acquired from our partner Spectrum Pharmaceuticals. We are also on track to have our import drug registration application for MARQIBO filed with the Chinese FDA by the third quarter of this year, and plan to file the import drug registration application for EVOMELA once our partner receives FDA NDA approval in the U.S. We continue to pursue our goal of reaching the earliest possible launch and market penetration in China and our other markets for all our late-stage products."
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 ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and EVOMELA™ (CE-Melphalan HCl) for injection for greater China (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 atwww.casipharmaceuticals.com and in the Company's filings with the U.S. Securities and Exchange Commission.
About ZEVALIN and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen. Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.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; the difficulty of executing our business strategy inChina; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidate 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; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest stockholders that differ from our other stockholders; and the risk of substantial dilution of existing stockholders in future stock issuances. 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.