Pfizer Inc. (PFE) recently announced the suspension of studies of tanezumab for chronic low back pain and diabetic nerve pain. The decision was taken following a request by the US Food and Drug Administration (FDA). For the time being, these studies will not recruit new patients and patient-dosing will be suspended.Earlier, in June, the regulatory body had asked Pfizer to stop testing tanezumab in patients with osteoarthritis based on reports of the disease becoming more severe in a few patients who were treated with tanezumab, so much so that patients needed to undergo joint replacement. The current suspension is the result of further evaluation of these adverse events leading to concern on the part of the FDA about the possibility of the recurrence of such side effects in other patient populations taking tanezumab.
Pfizer plans to continue working with the FDA in order to determine the future of the drug. Tanezumab is also being evaluated for the treatment of cancer pain, for which a trial is currently ongoing.
Earlier Pipeline Setbacks
The suspension of tanezumab studies is the latest in a series of pipeline setbacks suffered by the company. Pfizer’s other recent high-profile pipeline failures include torcetrapib for high cholesterol; dalbavancin (Zeven), an antibiotic for the treatment of skin infections; inhaled insulin drug, Exubera; Sutent (liver cancer); and melanoma candidate tremelimumab. Pfizer is currently exploring strategic alternatives (like out-licensing or sale) for Fablyn, which failed to receive FDA approval for the treatment of osteoporosis in post-menopausal women.
| Overall Summary: |  70%, Bullish 30%, Bearish | Trade Quality: | Upside 80%, V. Good Downside 80%, V. Good |
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| Oppenheimer & Co. Inc. | $18 | ||||||||||||||||||||||||||||||||||
| Buy | |||||||||||||||||||||||||||||||||||
Friday, May 21, 2010
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