Puma Biotechnology (Nasdaq: PBYI) has agreed to terminate its 2018 license agreement with China-based CANbridge Pharmaceutical, in which the latter was granted exclusive rights to develop and commercialize Nerlynx (neratinib) in Greater China, and to settle their arbitration related to the license agreement.
Simultaneous, Puma – whose shares dipped 2.7% to $10.26 by mid-morning - has agreed with privately-held French drugmaker Pierre Fabre 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.
At the same time, CANbridge and Pierre Fabre have entered into agreements under 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.
Financial terms
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, founder, chairman and chief executive of CANbridge 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.”
Alan Auerbach, CEO president of Puma, said: “We are pleased to extend our collaboration with Pierre Fabre into the Greater China region. Pierre Fabre is well equipped with existing infrastructure to make Nerlynx a success in mainland China and Pierre Fabre plans to make Nerlynx available to breast cancer patients in mainland China in the second quarter of this year.”
Neratinib is approved in the USA 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.
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