Puma Biotechnology, has signed an agreement with Pfizer to license the worldwide commercial rights to neratinib, a potent, irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, ErbB1 (EGFR), ErbB2 (HER2) and ErbB4 (HER4) kinases. Neratinib is being studied in the neoadjuvant, adjuvant and metastatic settings in patients with HER2/ErbB2 positive breast cancer.
Under the terms of the agreement, Puma will assume sole responsibility of global product development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma's achievement of certain development milestones of neratinib, as well as royalty payments for any sales of neratinib.
Puma intends to focus the development of neratinib on the treatment of patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. Neratinib has previously been tested in numerous clinical trials both as single agent and in combination with other anticancer drugs in this patient population.