Spectrum out-licenses rights for China to CASI Pharmaceuticals for three of its drugs

ZEVALIN is used in the treatment of non-Hodgkin’s lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL).

CE melphalan has met the endpoints in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.

Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half of 2014.

CASI will be responsible for the development and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China, if and as required.

"We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.

"The management of CASI has a track record of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development and look forward to CASI creating value for our shareholders as they grow. China’s pharmaceutical market is growing at a rapid pace and is already approaching second place to only the United States in the world.

"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 are impressed with the management team at CASI and their expertise in China, and look forward to sharing in the success of our drugs in this important market."

Commenting on the transaction, Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, said, "We are very excited to have entered into this transaction with Spectrum, a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones normally associated with traditional licenses, thereby aligning Spectrum’s interest with our shareholders. We look forward to a productive relationship with Spectrum."

Dr. Ren added, "These drug products come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory."

In addition to its initial stake in CASI, Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals also will have the opportunity to designate a member to CASI’s board of directors. Detailed information on the transaction can be found in CASI’s Report on Form 8-K, which will be filed with the Securities and Exchange Commission.