Recently, Pfizer Inc. (PFE) halted studies being conducted with pipeline candidate tanezumab, which is being developed for the treatment of patients suffering from osteoarthritis. The global suspension comes in the wake of the FDA's request to the pharma major to stop the osteoarthritis clinical program.
The request was based on reports of the disease becoming more severe in a few patients who were treated with tanezumab. The increased severity led to joint replacement.
We note that Pfizer is also evaluating the candidate for treating cancer pain, interstitial cystitis, lower back pain and diabetic nerve pain. However, the adverse event witnessed in the osteoarthritis program is yet to be observed in the programs being conducted with non-osteoarthritis patients. The agency has directed the company to present its assessment of the potential implications of the adverse events witnessed in the osteoarthritis program in the studies being carried out with non-osteoarthritis patients.
The clinical hold placed by the FDA is applicable to patients in the osteoarthritis program as well as osteoarthritis patients in other clinical programs being conducted by the company with tanezumab.
Pipeline Setbacks Continue
The current pipeline setback is one of the many suffered by the company of late. 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.
The company also faced some high profile pipeline failures for its central nervous system (CNS) pipeline including insomnia drug Indiplon and antipsychotic asenapine.
Presently, we have low visibility on Pfizer’s future development plans for tanezumab.
Currently, we are Neutral on Pfizer with a Zacks Rank of #3, which indicates that the stock is expected to perform in line with the overall US equity market for the next 1-3 months. Our long-term Neutral stance on the company indicates that the stock is expected to replicate its short-term performance, but over 6-12 months. Consequently, we advise the investors to retain the stock over the time-period.