Merck says it nailed the positive Phase III data it needs to gain an approval on the late-stage osteoporosis drug odanacatib, allowing investigators to start wrapping up the big global study and accelerating the timeline on the potential blockbuster.
The "robust efficacy and a favorable benefit-risk profile" of the treatment convinced the advisory group for the trial to call it a success for women with post-menopausal osteoporosis. The study was launched five years ago and recruited 16,000 patients at 387 sites around the world. The news sets up probable regulatory filings in the U.S., Europe and Japan in the first half of next year.
That's particularly good news for Merck ($MRK), a pharma giant that has counted the treatment as one of its top late-stage prospects. Credit Suisse's Catherine Arnold has put potential peak sales at a bit more than a billion dollars a year. Thomson Pharma, though, put the average sales forecast at $402 million, reports Reuters. As a prime candidate to compete with Amgen's ($AMGN) Prolia, some analysts have been lukewarm at best about its prospects.
"Most people have viewed 'odana' as likely to work, but not likely to sell well given generic competition," ISI's Mark Schoenebaum wrote a few days ago, according to a report from Bloomberg. "However, if the Phase III is stopped early for efficacy, it could begin to change Street opinion."
Initial indications are that the rehab process may have begun. Merck shares jumped 3% on the news. But Merck--which has failed to generate much excitement for its full list of late-stage programs--did sound a note of caution, adding that an extension trial is being pursued to fully sound out some safety issues that arose in the study.
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