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Puma Biotechnology enters licensing deal for cancer drug in Greater China

Puma Biotechnology Inc. entered into an exclusive licensing agreement with CANbridge Life Sciences Ltd. to develop and commercialize the breast cancer drug Nerlynx in mainland China, Taiwan, Hong Kong and Macau, also called the Greater China region.

Nerlynx, or neratinib, is approved by the U.S. Food and Drug Administration for post-surgery treatment for adults with early-stage HER2-positive breast cancer, after they have first been treated with Roche Holding AG's Herceptin. The drug is currently not available outside the U.S.

CANbridge Life Sciences will be responsible for seeking the required regulatory approvals and for commercializing the drug. Under the agreement, Puma will receive an up-front payment of $30 million and potential payments totaling up to $40 million upon achieving certain regulatory milestones.

Puma will also receive significant double-digit royalties on Nerlynx sales in Greater China and potential payments upon achieving certain sales-based milestones.

The drug is expected to be commercially available in parts of Greater China by mid-2019, said James Xue, CEO and president of CANbridge Life Sciences.

CANbridge develops partnerships with Western biopharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China or northern Asia or that address medical needs that are underserved in the region.