05 Apr 2009 06:00 AM
Pfizer Development Pipeline Shows Advances In High-Priority Disease Areas
Pfizer Inc provided an update to its pipeline, highlighting the progression of clinical programs in high-priority therapeutic areas, and announced the start of Phase 3 clinical trials for two new molecular entities. In total, the company initiated seven Phase 3 programs within the past six months.
Earlier this year, Pfizer started Phase 3 studies in a first-in-class JAK inhibitor (CP-690,550), the first orally-administered, disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis in 10 years, based on promising Phase 2 efficacy and safety data. Rheumatoid arthritis impacts 1.3 million Americans and can be severe, debilitating, deforming and even shorten life. Pfizer is also conducting Phase 3 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.
"We are executing on our commitment to bring new and effective therapies to patients around the world in areas where there is a significant unmet medical need," said Ian Read, president, Worldwide Pharmaceutical Operations.
The company has initiated 12 Phase 3 clinical programs since March 2008, achieving its goal of advancing between 10 and 12 new molecular entities and new indications into late-stage development by March 2009. Pfizer reaffirmed the additional R&D objectives shared with investors in March 2008: 15-20 Phase 3 starts in 2008-2009, growing the Phase 3 pipeline to at least 24 and as many as 28 new molecular entities or new indications by December 2009 and 15-20 regulatory submissions from 2010 to 2012.
The Pfizer pipeline now reflects a therapeutic-area focus, with 100 programs in Phase 1 through Registration. In total, 21 programs advanced in the pipeline since September 2008, 12 of them in the identified high-priority disease areas of diabetes, oncology, inflammation/immunology, Alzheimer's disease, psychoses and pain.
"We are continuing to better align our pipeline candidates with the identified needs of patients and healthcare providers worldwide," said Mr. Read. "Importantly, our new business unit structure will enable us to advance our development programs with urgency and efficiency in support of achieving our regulatory submission goal and providing high value therapies…
Earlier this year, Pfizer started Phase 3 studies in a first-in-class JAK inhibitor (CP-690,550), the first orally-administered, disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis in 10 years, based on promising Phase 2 efficacy and safety data. Rheumatoid arthritis impacts 1.3 million Americans and can be severe, debilitating, deforming and even shorten life. Pfizer is also conducting Phase 3 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.
"We are executing on our commitment to bring new and effective therapies to patients around the world in areas where there is a significant unmet medical need," said Ian Read, president, Worldwide Pharmaceutical Operations.
The company has initiated 12 Phase 3 clinical programs since March 2008, achieving its goal of advancing between 10 and 12 new molecular entities and new indications into late-stage development by March 2009. Pfizer reaffirmed the additional R&D objectives shared with investors in March 2008: 15-20 Phase 3 starts in 2008-2009, growing the Phase 3 pipeline to at least 24 and as many as 28 new molecular entities or new indications by December 2009 and 15-20 regulatory submissions from 2010 to 2012.
The Pfizer pipeline now reflects a therapeutic-area focus, with 100 programs in Phase 1 through Registration. In total, 21 programs advanced in the pipeline since September 2008, 12 of them in the identified high-priority disease areas of diabetes, oncology, inflammation/immunology, Alzheimer's disease, psychoses and pain.
"We are continuing to better align our pipeline candidates with the identified needs of patients and healthcare providers worldwide," said Mr. Read. "Importantly, our new business unit structure will enable us to advance our development programs with urgency and efficiency in support of achieving our regulatory submission goal and providing high value therapies…

