Pfizer (New York) outlined the progress of its late-stage pipeline last week and announced this week plans to separate its research activities into two organizations, one focused on small molecules and the other on biologics, pending the closure of its pending acquisition with Wyeth.
Pfizer began Phase III clinical programs for two new molecular entities (NMEs) this year and started seven Phase III programs within the past six months. As a result of positive Phase II efficacy and safety data, the company initiated Phase III studies of a JAK inhibitor (CP-690,550) that it claims is the first orally-administered, disease-modifying antirheumatic drug for rheumatoid arthritis in 10 years. The other NME in Phase III trials is tanezumab, a fully humanized monoclonal antibody against nerve growth factor. The drug reduced pain in patients suffering osteoarthritis of the knee in clinical studies, according to a company press release.
Pfizer has initiated 12 Phase III clinical programs since March 2008, thus meeting its goal of advancing between 10 and 12 NMEs and new indications into late-stage development by March 2009. The company plans to begin 15–20 Phase III trials in 2008–2009, thus expanding its Phase III pipeline to 24–28 NMEs or new indications by December 2009. Pfizer also intends to file 15–20 regulatory submissions between 2010 and 2012.
In addition, Pfizer added two late-stage candidates to its pipeline through business-development opportunities and partnerships. Together with Medivation (San Francisco), the company is developing Dimebon for the treatment of Alzheimer’s disease (AD). Dimebon is in Phase III trials. The drug’s mechanism of action is thought to differ from that of currently available AD medications, and the drug successfully completed Phase II studies for Huntington’s disease. Pfizer’s Specialty Care Business Unit entered into a strategic alliance with Auxilium Pharmaceuticals (Malvern, PA) to develop Xiaflex. The drug's ability to treat Dupuytren’s contracture is being studied in Phase III trials, and its ability to combat Peyronie’s Disease is the subject of Phase II trials.
During the past six months, Pfizer discontinued 26 programs that did not fit its therapeutic-area focus or that demonstrate a sufficient clinical utility and customer value. The company will try to monetize some of the compounds through business-development transactions such as outlicensing and partnering.
In a related story, Pfizer received a US Federal Trade Commission (FTC) request for additional information about its proposed acquisition of Wyeth (Madison, NJ). The request had been expected as part of the regulatory process under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 (HSR Act).
In a press release, Pfizer said it would respond quickly to the request and fully cooperate with the FTC during its review. The merger’s completion is subject to the expiration of the waiting period under the HSR Act, governmental and regulatory approvals, the approval of Wyeth’s stockholders, the satisfaction of conditions related to the debt financing for the transaction, and other customary closing conditions. The two companies expect the transaction to close by the end of the third quarter of 2009.
Pfizer also announced this week its plan to form two separate research organizations, one focused on small molecules and related modalities (the PharmaTherapeutics Research Group) and one on larger molecules and vaccines (the BioTherapeutics Research Group), upon the closing of its pending acquisition of Wyeth. The PharmaTherapeutics Research Group will be headed by Martin Mackay, who now leads Pfizer Global Research and Development. Mikael Dolsten, who currently is president of research for Wyeth, will head the BioTherapeutics Research Group.