Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Merck & Co. Inc. (MRK) announced encouraging data from a pivotal phase III fracture outcomes study evaluating the use of odanacatib in postmenopausal women suffering from osteoporosis. The data from the study was presented at the American Society for Bone and Mineral Research Annual Meeting.
The randomized, double-blind, placebo-controlled, event-driven Long-term Odanacatib Fracture Trial (LOFT) compared odanacatib to placebo in 16,713 women above 65 years suffering from osteoporosis, who have been postmenopausal for five years or more.
The study met the primary endpoint. Odanacatib significantly reduced the risk of new and worsening morphometric vertebral fractures (54%), clinical hip fractures (47%), clinical non-vertebral fracture (23%) and clinical vertebral fractures (72%) compared with placebo.
However in LOFT, it was found that side effects including morphea-like skin lesions and atypical femoral fractures occurred more frequently in the odanacatib arm than the placebo arm. Additionally, higher number of adjudicated stroke events occurred in the odanacatib arm.
Based on the currently available data, the company believes that benefits associated with the use of odanacatib the risks and plans to submit a regulatory application in the U.S. next year. We note that the company was earlier planning to submit marketing application in the second half of 2014. The company also plans to seek approval in the EU and Japan.
Merck carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD), Biogen Idec Inc. (BIIB) and Amgen Inc. (AMGN). While Gilead is a Zacks Rank #1 (Strong Buy) stock, Amgen and Biogen carry a Zacks Rank #2 (Buy).
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