On February 25, 2021 CANbridge Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing drug candidates in China and North Asia, and Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that they have agreed to terminate their 2018 license agreement, in which Puma granted CANbridge exclusive rights to develop and commercialize NERLYNX (neratinib) in Greater China, and to settle their arbitration related to the license agreement (Press release, CANbridge Life Sciences, FEB 25, 2021, View Source [SID1234575693]).
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Simultaneous to the termination of the 2018 license agreement between CANbridge and Puma, Puma has agreed with Pierre Fabre, a global pharmaceutical and healthcare products company, to amend the terms of their 2019 license agreement, which grants Pierre Fabre exclusive rights to develop and commercialize NERLYNX within Europe, Turkey, Middle East and Africa, to also include Greater China, which includes mainland China, Taiwan, Hong Kong and Macau. CANbridge and Pierre Fabre have also simultaneously entered into agreements pursuant to which CANbridge will provide Pierre Fabre certain transition services in Greater China and distribute and market NERLYNX for Pierre Fabre in Hong Kong, Macau, and Taiwan until year end 2022, with an option to renew.
Under the terms of the various agreements implementing this transaction among the three companies, Puma will receive an upfront payment of $50 million from Pierre Fabre in consideration for the amendment to their 2019 license agreement, and CANbridge will receive a one-time $20 million termination fee from Puma to return all rights to neratinib in Greater China back to Puma. Finally, Puma has agreed to dismiss the arbitration demand it filed on July 28, 2020 against CANbridge related to the parties’ 2018 license agreement, and as part of the settlement, CANbridge has agreed to dismiss its counterclaims against Puma.
James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc., said, "We are pleased to have reached a mutually beneficial agreement that also serves patients, as CANbridge shifts its focus to rare disease and rare oncology. We look forward to working closely with Pierre Fabre to continue to bring this important medicine to patients in Hong Kong, Taiwan and Macau."
Neratinib is approved in the United States for both the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and HER2-positive metastatic breast cancer and is marketed in the United States as NERLYNX (neratinib) tablets.
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.