Under the agreement, Puma will assume sole responsibility ofglobal product development and commercialization of neratinib. Pfizer will beentitled to receive payments upon Puma's achievement of certain developmentmilestones of neratinib, as well as royalty payments for any sales ofneratinib.
Financial terms of the deal were not disclosed.
Neratinib came into the Pfizer portfolio with its 2009acquisition of Wyeth. It is a potent, irreversible tyrosine kinase inhibitorthat blocks signal transduction through the epidermal growth factor receptors,ErbB1 (EGFR), ErbB2 (HER2) and ErbB4 (HER4) kinases. Neratinib is being studiedin the neoadjuvant, adjuvant and metastatic settings in patients withHER2/ErbB2 positive breast cancer.
Puma is focused on licensing in anticancer drugs fordevelopment. The firm has been set up by Alan H. Auerbach, who also founded andwas CEO at Cougar Biotechnology, which Johnson & Johnson took over in 2009.
"To date, neratinib has demonstrated strong evidence ofantitumor activity, both as a single agent and in combination with otheranticancer drugs, in patients with HER2-positive locally advanced or metastaticbreast cancer who have received prior lines of treatment that includetrastuzumab-based therapy," Auerbach says. "We look forward to the continueddevelopment of neratinib in this patient population."
Pfizer spokeswoman Gwendolyn E. Fisher says Puma proved tobe an attractive partner for the licensing agreement because "with founder AlanAuerbach's track record and passion for innovation in oncology, Pfizer hasevery confidence that Puma will provide a positive future for neratinib. With arange of compounds in the Pfizer oncology pipeline, we have the opportunity topartner with innovative companies, like Puma, and realize greater potentialfrom our oncology portfolio. This agreement is an example of our effort to setpriorities and collaborate in the interest of cancer patients worldwide. Pumabrings the requisite focus and confidence to this collaboration."
Puma intends to focus the development of neratinib on thetreatment of patients with HER2-positive locally advanced or metastatic breastcancer who have received prior trastuzumab-based therapy. Neratinib haspreviously been tested in numerous clinical trials both as single agent and incombination with other anticancer drugs in this patient population. In thesestudies, neratinib demonstrated substantial clinical activity and was welltolerated. Based on the results of these studies, Puma intends to initiateclinical trials in this patient population in the first half of 2012.
Garry Nicholson, president and general manager of Pfizer'sOncology unit, explains the agreement is part of the company's strategy oflicensing out any compounds it feels would be better served by being developedexternally.
"This strategic approach helps ensure that people living with cancer canpotentially benefit from promising drugs, regardless of where they aredeveloped," he adds. "We are actively prioritizing our oncology portfolio,which includes deciding which compounds to develop internally and whichcompounds we believe may have better opportunities for development externally.This strategic approach helps ensure that people living with cancer canpotentially benefit from promising drugs, regardless of where they aredeveloped."
Nicholson also points out that Auerbach has an excellenttrack record in advancing important oncology compounds.
"We are pleased that Puma Biotechnology will continue theevaluation of neratinib in patients living with cancer," he adds.
Prior to the licensing agreement with Puma, Pfizer had beensponsoring two clinical trials of neratinib: the NEfERTT trial, a Phase IIrandomized trial of neratinib in combination with paclitaxel versus trastuzumabin combination with paclitaxel for the treatment of patients who have notreceived previous treatment for HER2-positive metastatic breast cancer, and theExteNET trial, a Phase III study investigating the effects of neratinib afteradjuvant trastuzumab in patients with early stage breast cancer.
In keeping with Puma's strategy to refocus clinicaldevelopment of neratinib in patients with HER2-positive metastatic breastcancer who have received prior lines of trastuzumab-based therapy, Puma intendsto stop enrollment of new patients and proceed with winding down both trials.
Puma also unveiled a private placement of approximately 14.7million shares of its common stock to institutional investors that resulted ingross proceeds of approximately $55 million to the company. The shares wereissued at a purchase price of $3.75 per share. Leerink Swann LLC acted as soleplacement agent for the transaction.
"We are pleased to be able to close this private placementwith such a leading group of institutional healthcare investors," saysAuerbach. "We expect the proceeds from this financing will allow us to moveforward expeditiously with the clinical development of neratinib."
Pfizer, GlycoMimeticsin deal for sickle cell drug
GAITHERSBURG, Md.—Pfizer Inc. also announced last month thatit has entered into an exclusive worldwide licensing agreement with GlycoMimeticsInc. for the GlycoMimetics investigational compound GMI-1070.
GMI-1070 is a pan-selectin antagonist currently in Phase IIdevelopment for the treatment of vaso-occlusive crisis associated with sicklecell disease. GMI-1070 has received Orphan Drug and Fast Track status from theU.S. Food and Drug Administration (FDA).
Vaso-occlusive crisis, which can last five to six days onaverage, results in more than 75,000 hospitalizations each year in the UnitedStates. These crises cause pain and tissue damage leading to multiple organdamage, a requirement for life-long narcotic pain medications, and eventuallyto significantly shorter life spans. While the genetic and molecular cause ofsickle cell disease has been known for more than 50 years, therapy for painfulcrises has not significantly advanced. GMI-1070 is thought to inhibit selectininteractions, a key early step in the inflammatory process leading tovaso-occlusive crisis. In preclinical studies, GMI-1070 restored blood flow toaffected vessels of sickle cell animals experiencing vaso-occlusive crisis.
Under the terms of the agreement, Pfizer will receive anexclusive worldwide license to GMI-1070 for vaso-occlusive crisis associatedwith sickle cell disease and for other diseases for which the drug candidatemay be developed. GlycoMimetics will remain responsible for completion of theongoing Phase II trial under Pfizer's oversight, and Pfizer will then assumeall further development and commercialization responsibilities. The potentialvalue of the agreement for GlycoMimetics is approximately $340 million,including an upfront payment as well as development, regulatory and commercialmilestones. GlycoMimetics is also eligible for royalties on any sales.