CASI Pharmaceuticals and Spectrum Pharmaceuticals (SPPI) announced the signing of a license agreement that gives CASI exclusive rights to develop three cancer drugs from Spectrum and market them in China, including Macau, Hong Kong, and Taiwan.
The agreement concerns the two approved cancer drugs Zevalin (ibritumomab tiuxetan) Injection non-Hodgkin's lymphoma (NHL) and Marqibo (vinCRIStine sulfate LIPOSOME injection) for acute lymphoblastic leukemia (ALL) as well as the investigational Phase 3 drug Captisol-Enabled Melphalan (CE melphalan) being studied as a conditioning treatment before autologous stem cell transplant in patients with multiple myeloma. Spectrum recently reported that Melphalan met its primary endpoint in its pivotal safety and efficacy trial. In view of the results, Spectrum said it intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the drug in the second half of 2014.
Under the terms of the agreement, CASI will take the lead in the development and marketing of all three drugs from Spectrum. This includes regulatory activities such as import drug registration applications and any confirmatory clinical studies in China that may be required in the future. As a stakeholder in CASI, the agreement also gives Spectrum the rights to keep its post-transaction ownership position and to appoint a member to CASI’s board of directors. No financial terms of the agreement were disclosed by either company.
Rajesh C. Shrotriya, Chairman and CEO of Spectrum Pharmaceuticals, said, “We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI… The greater China drug market for anticancer drugs is projected to become the world's largest in the next decade and CASI has the opportunity to take a leading position to address these significant unmet medical needs. We… look forward to sharing in the success of our drugs in this important market.”
Dr. Ken K. Ren, CEO of CASI, said, “The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China… We look forward to a productive relationship with Spectrum.” Dr. Ren added that CASI is preparing to submit drug registration applications for Zevalin and Marqibo in greater China while Melphalan’s will follow after its anticipated FDA approval.
A recent report forecasts the pharmaceutical market in China to hit $158 billion in 2016, almost double its $88 billion performance in 2012.