LOS ANGELES, Oct. 5, 2011 /PRNewswire/ -- Puma Biotechnology, Inc., a development stage biopharmaceutical company, today announced 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. In these studies, neratinib demonstrated substantial clinical activity and was well tolerated. Based on the results of these studies, Puma intends to initiate clinical trials in this patient population in the first half of 2012.
Prior to the licensing agreement with Puma, Pfizer had been sponsoring two clinical trials of neratinib: 1) the NEfERTT trial, a Phase II randomized trial of neratinib in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of patients who have not received previous treatment for HER2-positive metastatic breast cancer, and 2) the ExteNET trial, a Phase III study investigating the effects of neratinib after adjuvant trastuzumab in patients with early stage breast cancer. Consistent with Puma's strategy to refocus clinical development of neratinib in patients with HER2-positive metastatic breast cancer who have received prior lines of trastuzumab-based therapy, Puma intends to stop enrollment of new patients and proceed with winding down both trials.