Merck Provides Update on Phase III Clinical Program for Preladenant, the Company’s Investigational Parkinson’s Disease Medicine
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today provided an update on the clinical program for preladenant, Merck’s investigational adenosine A2A receptor antagonist for the treatment of Parkinson’s disease (PD). An initial review of data from three separate Phase III trials did not provide evidence of efficacy for preladenant compared with placebo.
Based on these results, Merck is taking steps to discontinue the extension phases of these studies and no longer plans to pursue regulatory filings for preladenant. The decision to discontinue these studies is not based on any safety finding. The results of these studies will be presented at an upcoming scientific meeting and will be submitted for publication in a peer-reviewed journal.
“While these results are disappointing, this program is an important example of Merck’s continued commitment to pursue promising science with the goal of bringing forward medicines that address important unmet medical needs,” said David Michelson, M.D., vice president, clinical research, Neuroscience and Ophthalmology at Merck Research Laboratories. “Parkinson’s disease is very complex, making it difficult to treat patients and develop novel therapeutic approaches. We are committed to neuroscience research and will be conducting further analyses of the data to inform the scientific community’s efforts in finding new approaches to treat this debilitating disease. We thank the investigators and importantly the Parkinson’s patients who participated in the preladenant clinical program.”
The Phase III clinical program for preladenant included three randomized, controlled clinical trials to evaluate safety and efficacy. Two of these studies assessed preladenant when added to levodopa therapy in patients with moderate-to-severe PD, and one assessed preladenant as monotherapy in early PD. More information about the preladenant Phase III clinical trials is available on www.clinicaltrials.gov.
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Merck 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent 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 2012 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).
Pam Eisele, 908-423-5042
Claire Mulhearn, 908-423-7425
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Posted: May 2013