Pfizer Provides Pipeline Update

Pfizer provided an update on the progression of clinical programs in its high-priority therapeutic areas, and announced the start of Phase III trials for two new molecular entities.

Earlier this year, Pfizer started Phase III studies in JAK inhibitor (CP-690,550), an orally-administered, disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis. The company is also conducting Phase III trials with tanezumab, a fully-humanized monoclonal antibody targeting nerve growth factor. Tanezumab significantly reduced pain in patients with osteoarthritis of the knee in clinical studies to date.

The company has initiated 12 Phase III programs since March 2008, meeting its goal of advancing between 10 and 12 new molecular entities and new indications into late-stage development within a year. Additional R&D objectives shared with investors in March 2008 included 15-20 regulatory submissions from 2010 to 2012.

The pipeline now includes a therapeutic-area focus, with 100 programs in Phase I through registration. In total, 21 programs advanced since September 2008, 12 of them in the identified high-priority disease areas of diabetes, oncology, inflammation/immunology, Alzheimer’s disease, psychoses and pain.

Pfizer added two late-stage candidates to the pipeline through external business development opportunities and partnerships. Together with Medivation, Pfizer is developing Dimebon, currently in Phase III for the treatment of Alzheimer’s disease (AD). Dimebon’s mechanism is thought to be distinct from currently available AD medications. It has successfully completed Phase II studies for Huntington’s disease. The company also entered into a strategic alliance with Auxilium Pharmaceuticals to develop XIAFLEX, a new drug being studied for Dupuytren’s contracture in Phase III and Peyronie’s Disease in Phase II.

“Last year, we refined our approach to research by refocusing our pipeline to allow us to better select targets and molecules for development and move high-priority projects forward with improved cycle times,” said Martin Mackay, Ph.D., president of Pfizer Global R&D. “We will continue to drive our strategies and make the operational improvements necessary to maximize our investments, accelerate development, and advance medical science.”

Through the company’s portfolio prioritization, 26 programs were discontinued in the last six months, 15 as a result of strategic decisions made last year and 11 due to clinical attrition. According to the company, it will seek to monetize some of the compounds that have been discontinued through business development transactions, such as out-licensing or partnering.