Puma roars with Pfizer licensing deal
November 2011
by David Hutton  |  Email the author


NEW YORK—Pfizer Inc. recently announced a licensing agreement with Puma Biotechnology Inc. for the development and marketing of neratinib, an experimental drug that has shown promise in treating a subset of breast cancer patients.  
Under 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.   Financial terms of the deal were not disclosed.
Neratinib came into the Pfizer portfolio with its 2009 acquisition of Wyeth. It is 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.   Puma is focused on licensing in anticancer drugs for development. The firm has been set up by Alan H. Auerbach, who also founded and was CEO at Cougar Biotechnology, which Johnson & Johnson took over in 2009.  
"To date, neratinib has demonstrated strong evidence of antitumor activity, both as a single agent and in combination with other anticancer drugs, in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior lines of treatment that include trastuzumab-based therapy," Auerbach says. "We look forward to the continued development of neratinib in this patient population."  
Pfizer spokeswoman Gwendolyn E. Fisher says Puma proved to be an attractive partner for the licensing agreement because "with founder Alan Auerbach's track record and passion for innovation in oncology, Pfizer has every confidence that Puma will provide a positive future for neratinib. With a range of compounds in the Pfizer oncology pipeline, we have the opportunity to partner with innovative companies, like Puma, and realize greater potential from our oncology portfolio. This agreement is an example of our effort to set priorities and collaborate in the interest of cancer patients worldwide. Puma brings the requisite focus and confidence to this collaboration."
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.  
Garry Nicholson, president and general manager of Pfizer's Oncology unit, explains the agreement is part of the company's strategy of licensing out any compounds it feels would be better served by being developed externally.

"This strategic approach helps ensure that people living with cancer can potentially benefit from promising drugs, regardless of where they are developed," he adds. "We are actively prioritizing our oncology portfolio, which includes deciding which compounds to develop internally and which compounds we believe may have better opportunities for development externally. This strategic approach helps ensure that people living with cancer can potentially benefit from promising drugs, regardless of where they are developed."  
Nicholson also points out that Auerbach has an excellent track record in advancing important oncology compounds.  
"We are pleased that Puma Biotechnology will continue the evaluation of neratinib in patients living with cancer," he adds.   Prior to the licensing agreement with Puma, Pfizer had been sponsoring two clinical trials of neratinib: 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 the ExteNET trial, a Phase III study investigating the effects of neratinib after adjuvant trastuzumab in patients with early stage breast cancer.
In keeping 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.  
Puma also unveiled a private placement of approximately 14.7 million shares of its common stock to institutional investors that resulted in gross proceeds of approximately $55 million to the company. The shares were issued at a purchase price of $3.75 per share. Leerink Swann LLC acted as sole placement agent for the transaction.  
"We are pleased to be able to close this private placement with such a leading group of institutional healthcare investors," says Auerbach. "We expect the proceeds from this financing will allow us to move forward expeditiously with the clinical development of neratinib."  

Pfizer, GlycoMimetics in deal for sickle cell drug  
GAITHERSBURG, Md.—Pfizer Inc. also announced last month that it has entered into an exclusive worldwide licensing agreement with GlycoMimetics Inc. for the GlycoMimetics investigational compound GMI-1070.  
GMI-1070 is a pan-selectin antagonist currently in Phase II development for the treatment of vaso-occlusive crisis associated with sickle cell disease. GMI-1070 has received Orphan Drug and Fast Track status from the U.S. Food and Drug Administration (FDA).  
Vaso-occlusive crisis, which can last five to six days on average, results in more than 75,000 hospitalizations each year in the United States. These crises cause pain and tissue damage leading to multiple organ damage, a requirement for life-long narcotic pain medications, and eventually to significantly shorter life spans. While the genetic and molecular cause of sickle cell disease has been known for more than 50 years, therapy for painful crises has not significantly advanced. GMI-1070 is thought to inhibit selectin interactions, a key early step in the inflammatory process leading to vaso-occlusive crisis. In preclinical studies, GMI-1070 restored blood flow to affected vessels of sickle cell animals experiencing vaso-occlusive crisis.  
Under the terms of the agreement, Pfizer will receive an exclusive worldwide license to GMI-1070 for vaso-occlusive crisis associated with sickle cell disease and for other diseases for which the drug candidate may be developed. GlycoMimetics will remain responsible for completion of the ongoing Phase II trial under Pfizer's oversight, and Pfizer will then assume all further development and commercialization responsibilities. The potential value of the agreement for GlycoMimetics is approximately $340 million, including an upfront payment as well as development, regulatory and commercial milestones. GlycoMimetics is also eligible for royalties on any sales.  

Code: E111122

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