Pfizer Announces Agreement with Puma Biotechnology and Lyrica Success

Pfizer LogoPfizer have announced an agreement with Puma Biotechnology for the development and commercialization of neratinib, an investigational oral, multi-targeted inhibitor of the ErbB1 (EGFR), ErbB2 (HER2) and ErbB4 (HER4) kinases.  The drug, which shows promise as a treatment for breast cancer, is being studied in the neoadjuvant, adjuvant and advanced settings in HER2/ErbB2 positive breast cancer.

Under the terms of the arrangement, Puma will undertake sole responsibility for global development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma’s achievement of certain development milestones for neratinib, as well as royalty payments for any sales.

Garry Nicholson, president and general manager of Pfizer Oncology stated that “Oncology is a priority for Pfizer. 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.”

Puma Biotechnology is a development-stage biopharmaceutical company dedicated to in-licensing and developing novel therapeutics for the treatment of cancer. The company was founded by Alan H. Auerbach, who previously served as founder, CEO and president of Cougar Biotechnology, which was acquired by Johnson & Johnson in 2009.

Lyrica Success

Pfizer also announced that a trial of its blockbuster Lyrica (pregabalin) has been ended early after interim results suggested that the drug was effective as a monotherapy for partial seizures in epilepsy patients.

Pfizer said an independent data monitoring committee has completed an interim analysis and recommended that the study be stopped “based on positive findings for the primary efficacy endpoint”. MacKay Jimeson, Pfizer’s spokesman, stated that “additional details will be made public when the double-blind code for the study has been appropriately released for general analyses to be conducted”. Updated results will be posted by April of 2012.

Lyrica, whose second-quarter sales increased 19% to $908 million, is currently approved to treat certain epileptic seizures, but only as an add-on to other anti-seizure drugs. It is also indicated for fibromyalgia and neuropathic pain.


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