Merck Statement on Changes to Clinical Studies of Vorapaxar

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (known as MSD outside the United States and Canada) today provided the following statement on the changes to the clinical studies for vorapaxar, one of the Company's investigational cardiovascular medicines, following an announcement from the two academic centers leading the studies of vorapaxar.

Merck is studying vorapaxar in two major clinical endpoint trials to evaluate the investigational medicine for the prevention of cardiac events: TRACER, a study in patients with acute coronary syndrome, and TRA-2P (also known as TIMI 50), a study in patients with prior heart attack, stroke and peripheral artery disease. Both studies are event-driven trials in which patients were planned to be followed for a minimum of one year, and both had completed enrollment.

The combined Data and Safety Monitoring Board for the two studies has reviewed the available safety and efficacy data, and made recommendations for study changes to the chairpersons. The study chairpersons have agreed to implement these changes, and communicated the following information to study investigators:

  • In the TRACER study, patients will discontinue study drug and investigators are to begin now to close out the study in a timely and orderly fashion.
  • In the TRA-2P study, study drug will be continued in patients who had experienced a previous heart attack or peripheral arterial disease (approximately 75 percent of the patients enrolled in the study), and will be immediately discontinued in patients who experienced a stroke prior to entry into the study or during the course of the study.

Merck plans to update its projections for regulatory filings for vorapaxar once the Company has received the efficacy and safety data from TRACER and can determine an updated completion date for TRA-2P.

TRACER has accumulated the pre-defined number of primary and major secondary endpoints, although not all patients will continue to receive study drug through the pre-specified one-year follow up. Merck continues to expect that the efficacy and safety data from TRACER will become available later this year and will be submitted for presentation at appropriate medical meetings.

"Cardiovascular disease remains the world's leading killer, and despite all of the advances that have been made in the field, millions of patients remain at risk for major cardiovascular events," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We remain committed to conducting large clinical trials such as TRACER and TRA-2P that are so critical to understanding new cardiovascular medicines and to advancing the standard of care for patients with heart disease. We thank the investigators and the patients involved in these two studies for their continued efforts to understand the potential role of vorapaxar in the treatment of cardiovascular disease."

Additional Background

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

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.

The primary endpoint of TRACER is the first occurrence of any component of the composite of cardiovascular death, heart attack, stroke, recurrent ischemia with re-hospitalization, and urgent coronary revascularization, compared to active control. (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.)

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.

The primary endpoint of TRA-2P is the first occurrence of any component of the composite of cardiovascular death, MI, stroke, and urgent coronary revascularization compared to placebo. (Clinicaltrials.gov identifier: NCT00526474; A Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients with Atherosclerosis.)

Conference Call

Investors are invited to a live webcast of Merck’s conference call today at 10:00 a.m. EST by visiting Merck's Web site, www.merck.com/investors/events-and-presentations/home.html. Institutional investors and analysts can participate in the call by dialing (877) 381-5782 or (706) 758-9927. Journalists are invited to listen in on the call by dialing (800) 399-7917 or (706) 758-9928. A replay of the webcast will be available starting at 1 P.M. today through 5 p.m. EST on Thursday, January 20, 2011. To listen to the replay, dial (800) 642-1687 or (706) 645-9291. The conference ID no. is 37368244.

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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