Pfizer reports 2Q13 earnings

Pfizer Inc. (NYSE:PFE) disclosed on a conference call to discuss its 2Q13 earnings on Tuesday that it plans to resume Phase III trials of tanezumab for chronic pain in 2014. The pharma said FDA lifted a partial clinical hold earlier this month on the anti- nerve growth factor (NGF) humanized mAb. FDA placed a partial clinical hold on NGF inhibitors including tanezumab in December 2012 based on peripheral nervous system effects in animal studies. Pfizer said the Phase III program will evaluate tanezumab for osteoarthritis pain, chronic low back pain and cancer pain.

Pfizer also said it anticipates a "several years delay" in the EU availability of rheumatoid arthritis (RA) drug Xeljanz tofacitinib following a second negative opinion earlier this month from EMA's CHMP. In the U.S., the pharma said it plans to submit by early 2015 a regulatory application for a delayed release formulation of the oral pan-Janus kinase (JAK) inhibitor (see BioCentury Extra, July 25). ...