Update on Phase III Trial for Odanacatib, Merck's Investigational Cat-K Inhibitor for Osteoporosis

Study met its primary efficacy outcomes at first planned interim analysis and is being concluded early

 

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jul 11, 2012 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today an update on the Phase III trial assessing fracture risk reduction with odanacatib, Merck's investigational cathepsin K (cat-K) inhibitor. The Data Monitoring Committee (DMC) for the study recently completed its first planned interim analysis for efficacy and recommended that the study be closed early due to robust efficacy and a favorable benefit-risk profile. As a result, Merck will begin taking steps to close the trial. The DMC noted that safety issues remain in certain selected areas and made recommendations with respect to following up on them. Merck's previously announced plan to conduct a blinded extension trial will allow further monitoring of the issues. The extension trial will also continue to measure efficacy.

Merck anticipates submitting regulatory applications for approval of odanacatib in the U.S., European Union (EU) and Japan in the first half of 2013.

"We are encouraged by the Data Monitoring Committee's recommendation to close the trial early," said Peter S. Kim, Ph.D., executive vice president, Merck and president, Merck Research Laboratories, "and look forward to reviewing the data with the scientific community to bring forward this innovation."

The Phase III randomized, placebo-controlled trial with over 16,000 patients was designed to assess the safety and efficacy of odanacatib in reducing fracture risk in post-menopausal women with osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The interim analysis was conducted by the DMC as planned when approximately 70 percent of the targeted number of hip fractures had been reported.

Merck expects the process of closing this large, multi-center trial to take a number of months. Trial investigators will schedule final assessments for trial participants at 387 sites in 40 countries. Data from these visits will be collected and reviewed to allow a full and complete analysis, and final results of the study will be submitted for presentation and publication in 2013 once the analysis is complete.

About Odanacatib

In osteoporosis, bone loss occurs because of an imbalance in bone remodeling (the rate of bone resorption exceeds that of bone formation). Osteoclasts, cells that resorb bone, secrete signaling factors to stimulate osteoblasts, cells that form bone. Odanacatib selectively inhibits cat-K, the primary enzyme in the osteoclast that digests proteins during bone resorption, while maintaining the number of osteoclasts. This novel mechanism of action of odanacatib leads to improved balance in bone remodeling and bone formation is preserved while bone resorption is reduced, resulting in progressive increases in bone mineral density over time.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

 

 

Contact: Merck
Media:
Ian McConnell, 908-423-3046
or
Investor:
Carol Ferguson, 908-423-4465
Alex Kelly, 908-423-5185

 

 

Posted: July 2012


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