Merck Says Additional Information Provided to Investigators in Clinical Study of Vorapaxar

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (known outside the United States and Canada as MSD) reported today that investigators in the TRA-2P study of vorapaxar have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of vorapaxar. Vorapaxar is one of Merck's investigational cardiovascular medicines.

This communication follows announcements issued on Thursday, January 13 by the academic centers leading TRA-2P and TRACER, the two large clinical studies of vorapaxar, and by Merck (http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_0113.html). Those communications reported on changes being made to these clinical studies following recommendations from the joint DSMB overseeing the studies. In the new communication, Dr. Eugene Braunwald, Chairman of the TRA-2P study, reported to investigators that:

"The DSMB has communicated to us that based on all of the data (safety and efficacy) available to them from both trials, they recommend that subjects with a history of stroke not receive vorapaxar. They have observed an increase in intracranial hemorrhage in patients with a history of stroke that is not outweighed by their considerations of potential benefit."

Commenting on the new communication, Dr. Braunwald said, "In contrast, on the basis of their risk/benefit assessment in patients without a history of stroke, the DSMB recommended to us that it is important that the trial continue to completion in the more than 20,000 subjects who qualified for the trial with myocardial infarction or peripheral arterial disease who have not had a stroke. On the basis of their recommendation, we and Merck remain committed to completing this important scientific investigation with a potential for a reduction in death and ischemic events in these patients."

The two major clinical endpoint trials to evaluate vorapaxar for the prevention of cardiac events are: TRA-2P (also known as TIMI 50), a study in patients with prior heart attack, stroke and peripheral artery disease, and TRACER, a study in patients with acute coronary syndrome.

Vorapaxar is a selective PAR-1 (Protease Activated Receptor 1) Thrombin Receptor Antagonist designed to diminish thrombosis (clot formation).

TRA-2P, or TIMI 50, is a chronic care, secondary prevention study of approximately 26,500 patients who have experienced a heart attack, an ischemic stroke, or have documented peripheral vascular disease. In TRA-2P, vorapaxar is administered at a 2.5 mg daily dose. The study completed enrollment in November 2009. (Clinicaltrials.gov identifier: NCT00526474; A Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients with Atherosclerosis.)

TRACER is an acute care (hospital-based) study of approximately 13,000 patients with non-ST-segment-elevation acute coronary syndrome. In TRACER, vorapaxar was administered starting with a 40 mg loading dose, followed by a 2.5 mg daily dose. The study completed enrollment in June 2010. (Clinicaltrials.gov identifier: NCT00527943; A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome.)

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.

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 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; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally 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 2009 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).



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