Merck (MRK) recently presented new clinical and pre-clinical data on its phase III pipeline candidate, odanacatib. Odanacatib is an investigational cathepsin K (cat-K) inhibitor which is being developed for the treatment of osteoporosis in post-menopausal women.
Results were presented from a phase IIb clinical study extending to five years. Merck said that postmenopausal women being treated with odanacatib 50 mg weekly continuously for five years experienced an increase in bone mass density (BMD) at the lumbar spine (11.9% increase from baseline), femoral neck (9.8% increase from baseline), hip trochanter (10.9% increase from baseline), and total hip (8.5% increase from baseline).
However, adverse and serious adverse experiences were higher in the odanacatib treatment group. Adverse experiences and serious adverse experiences were 89% and 22%, respectively in the odanacatib arm, compared to 81% and 20%, respectively, in the placebo arm.
These results were presented at the annual meeting of The American Society for Bone and Mineral Research (ASBMR).
Odanacatib’s safety and potential effects on hip, vertebral and non-vertebral fractures is currently being evaluated in a large-scale phase III study. Merck intends to file for approval of odanacatib in 2013. Once approved, odanacatib will compete with players like Amgen’s (AMGN) Prolia and Eli Lilly’s (LLY) Forteo among others.
Merck already has an osteoporosis treatment, Fosamax, in its product portfolio. Fosamax and Fosamax Plus D are indicated for the treatment of osteoporosis in postmenopausal women. However, Fosamax is facing generic competition.
Neutral on Merck
We currently have a Neutral recommendation on Merck, which carries a Zacks #3 Rank (short-term Hold rating). Merck is currently facing issues such as patent expirations of key drugs, EU pricing pressure, US health care reform, and pipeline setbacks.
We believe the company will continue resorting to cost-cutting initiatives to drive the bottom-line. Meanwhile, some of the company’s recent launches should start contributing significantly to the top line in the forthcoming quarters.
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