Pfizer Discontinues Two Phase III Primary Care Projects
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer is halting development of treatments for generalized anxiety disorder and fibromyalgia.
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Pfizer is stopping work on two Phase III primary care programs, PD 332,334 for generalized anxiety and esreboxetine for fibromyalgia, to redirect resources to higher potential candidates, the company announced Feb. 24. Pfizer called the programs' termination a "business decision," noting, "We looked at existing data on '334 and esreboxetine, the current market data and our existing resources." Based on data from an initial Phase III trial of '334 and data for esreboxetine, Pfizer said neither compound is likely to provide a meaningful benefit to patients beyond the current standard of care. Approximately 900 patients were enrolled in esreboxetine trials and 760 patients were enrolled in studies for '334 when the decision was made. Pfizer is asking clinical investigators involved in those trials to advise their patients on how to proceed. The action comes after Pfizer retooled its development and commercial operations, adding three new business units in primary care, specialty care and emerging markets to three that already exist (1 (Also see "Pfizer Restructures For A More Flexible Future" - Pink Sheet, 13 Oct, 2008.)). The discontinuation of the two development programs follows a review of the primary care pipeline after the new business unit structure went into effect Jan. 1, Pfizer said. Only last October, Pfizer highlighted esreboxetine, along with several others, as part of a presentation on its extensive pain R&D portfolio to analysts at the American College of Rheumatology. Pfizer is considering out-licensing the drugs. "One thing about the restructuring of our research group is that anytime we decide not to develop something internally, there is always an opportunity to monetize it externally through business development opportunities," the firm said. The decision to halt the two drugs comes as pricing pressures, generic competition and comparative effectiveness issues increase the difficulty of marketing primary care drugs that lack clear efficacy or safety differentiation in crowded therapeutic categories. Pfizer established the drug category for fibromyalgia with Lyrica (pregabalin), the first drug approved for the indication, cleared by FDA in 2007 (2 (Also see "Pfizer’s Lyrica Is First Drug Approved For Fibromyalgia" - Pink Sheet, 21 Jun, 2007.)). Since then, two additional drugs have been approved for the indication - Lilly's antidepressant Cymbalta (duloxetine) and Forest's Savella (milnacipran) -making for an increasingly crowded market. Similar to Cymbalta and Savella, both selective serotonin and norepinephrine reuptake inhibitors, esreboxetine is a selective inhibitor of norepinephrine reuptake. Pfizer had previously said it was seeking to improve upon Lyrica with esreboxetine, not introduce a follow-on drug. In its announcement, Pfizer said it is continuing to support research and education related to fibromyalgia. In generalized anxiety disorder, Cymbalta and Wyeth's antidepressant Effexor XR (venlafaxine) are both approved for the indication, and AstraZeneca filed its atypical antipsychotic Seroquel (quetiapine) for GAD last year. Pfizer is also developing Lyrica for GAD, an indication it will continue to pursue. Pfizer has completed the Phase III program for Lyrica in GAD, but would not speculate on a filing timeline. The company will also continue to pursue the pain medication tanezumab into areas beyond osteoarthritis, the firm said. The company is currently studying the nerve growth factor inhibitor in Phase III for osteoarthritis of the knee (3 (Also see "Pfizer’s Tanezumab For Pain Turns Heads At Rheumatology Meeting" - Pink Sheet, 31 Oct, 2008.)). -Jessica Merrill ([email protected]) |