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Merck & Co., Inc. (MRK) Moves Alzheimer's Drug Into Big Trials After Safety Review


12/10/2013 7:19:44 AM

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Merck Advances Development Program for Investigational Alzheimer's Disease Therapy, MK-8931

WHITEHOUSE STATION, N.J., Dec 10, 2013 (BUSINESS WIRE) -- --Merck also plans to initiate dosing in Phase III study of prodromal disease patients

Merck MRK +0.34% , known as MSD outside the United States and Canada, today provided an update on the development program for MK-8931, a novel investigational oral B-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase II/III "EPOCH" study in patients with mild to moderate Alzheimer's disease recently completed its planned interim safety analysis and recommended that the trial continue to recruit patients, with no changes to the protocol.

The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least 3 months. Based upon the DMC's recommendations, Merck will continue enrollment of the EPOCH study. In addition, Merck will initiate dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer's disease, also known as prodromal Alzheimer's disease.

"We are pleased to receive the DMC's recommendation and look forward to continuing the clinical development program for MK-8931," said Dr. David Michelson, vice president, Neuroscience, Merck Research Laboratories. "Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer's disease grows."

About the EPOCH Study

EPOCH is a randomized, placebo-controlled, parallel-group, double-blind Phase II/III clinical trial to evaluate the efficacy and safety of two oral doses of MK-8931 (12 and 40 mg) administered daily versus placebo in patients with mild to moderate Alzheimer's disease. The Phase II portion of the trial also included a 60 mg dose to evaluate safety. The trial is anticipated to enroll up to 1,960 patients. The primary efficacy outcomes of the study are the change from baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score following 78 weeks of treatment.

About the APECS Study

APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase III clinical trial to evaluate the efficacy and safety of MK-8931 in subjects with prodromal Alzheimer's disease. The study is designed to enroll 1500 participants. Patients will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary efficacy outcome of the study is change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score following 104 weeks of treatment.

About BACE Inhibition and MK-8931

The amyloid hypothesis asserts that the formation of amyloid peptides that lead to amyloid plaque deposits in the brain is a primary contributor to the underlying cause of Alzheimer's disease. BACE is believed to be a key enzyme in the production of amyloid B peptide. Evidence suggests that inhibiting BACE decreases the production of amyloid B peptide and may therefore reduce amyloid plaque formation and modify Alzheimer's disease progression.

Merck's Commitment to Patients Suffering from Alzheimer's Disease

Merck is committed to advancing the understanding and treatment of Alzheimer's disease. We are currently evaluating several innovative mechanisms in Alzheimer's disease, including candidates designed to modify disease progression and improve symptom control. Merck's major effort in disease modification is our lead investigational BACE inhibitor, MK-8931, that is being evaluated in late stage clinical trials for mild to moderate and prodromal Alzheimer's disease. In addition, Merck is conducting a Phase II clinical trial for MK-7622, an investigational adjunctive therapy to donepezil for the symptomatic treatment of participants with mild to moderate disease.

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.

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 healthcare legislation in the United States and internationally; global trends toward healthcare 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 ).

SOURCE: Merck

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