On February 25, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Pierre Fabre, a leading French pharmaceutical company, reported that they have agreed to extend the terms of the 2019 license agreement which grants Pierre Fabre exclusive rights to develop and commercialize NERLYNX (neratinib) within Europe, Turkey, Middle East and Africa (Press release, Puma Biotechnology, FEB 25, 2021, View Source [SID1234575691]). The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to Greater China, which includes mainland China, Taiwan, Hong Kong and Macau.
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Under the terms of the amendment, Puma will receive an upfront payment of $50 million, as well as additional regulatory and sales-based milestone payments that could add up to an additional $240 million. These milestones will be based solely on regulatory and sales achievements in Greater China. In addition, Puma will receive significant double-digit tiered royalties on the sales of NERLYNX in Greater China.
Concomitantly, Puma and CANbridge Pharmaceuticals, Inc., a biopharmaceutical company focused on developing drug candidates in China and North Asia, have mutually agreed to terminate the license agreement to commercialize NERLYNX (neratinib) in Greater China. Puma has agreed to pay CANbridge a one-time termination fee of $20 million to return all rights to neratinib in Greater China back to Puma. Additionally, 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. Such settlement is limited to claims that arose in arbitration, or could have been raised in arbitration, as well as claims arising under the to be terminated license agreement.
Alan H. Auerbach, Chief Executive Officer and 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."
"We are excited about the opportunity to provide NERLYNX to Chinese patients with early stage HER2-positive breast cancer," said Jean-Luc Lowinsky, Chief Executive Officer, Pierre Fabre Pharmaceuticals. "Our oncology team based in Shanghai is fully committed to start the commercialization of NERLYNX, which perfectly complements our existing NAVELBINE chemotherapy in breast and lung cancers."
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 for adult patients with advanced or metastatic HER2-positive breast cancer in combination with capecitabine in patients who have received two or more prior anti-HER2 based regimens 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.