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Merck & Co., Inc. (MRK) Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus


11/6/2012 2:10:29 PM

WHITEHOUSE STATION, NJ., November 2, 2012 – Today, Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced plans to initiate two new clinical trials with MK-5172, its investigational, once-daily, oral HCV NA3/4A protease inhibitor for the treatment of chronic hepatitis C (HCV) infection. The trials are designed to assess the efficacy and safety of MK-5172 in all-oral, interferon-free combination regimens in non-cirrhotic, treatment-naïve patients with chronic HCV genotype 1 infection.

“For more than 30 years, Merck has been leading innovation in viral hepatitis. The science is advancing rapidly, and we recognize that future HCV treatment regimens will not include interferon," said Roger Pomerantz, MD, FACP, senior vice president and Global Franchise Head for Infectious Diseases, Merck Research Laboratories. "The start of these new studies is the next step in our efforts to develop novel therapeutic regimens for the treatment of chronic hepatitis C. We look forward to evaluating the potential role of MK-5172 and our other earlier pipeline candidates for chronic HCV as part of our continuing commitment to improving patient care.”

The first clinical trial will evaluate a 12-week regimen containing MK-5172, MK-8742, an oral NS5A inhibitor in Phase I development, and ribavirin in non-cirrhotic treatment-naïve patients with HCV genotype 1 infection. The second clinical trial will evaluate 12- and 24-week regimens of MK-5172 in combination with ribavirin in non-cirrhotic treatment-naïve patients with HCV genotype 1 infection with an IL-28 CC genotype. More information is available at http://clinicaltrials.gov using identifiers, NCT01717326 and NCT01716156, respectively.

About MK-5172

MK-5172 is an investigational, once-daily, oral HCV NS3/4A protease inhibitor currently in Phase II development that has demonstrated potent in vitro antiviral activity. Early data on MK-5172 has shown a broad HCV genotypic activity spectrum and in vitro activity against genotype 1a and 1b viral variants that have been associated with resistance to other HCV protease inhibitors, including those in development. Given the clinical experience of MK-5172 to date, including its potentially high barrier to resistance and antiviral activity across HCV genotypes, Merck will evaluate MK-5172 in treatment regimens in a broad spectrum of patients with chronic HCV infection.

Merck's Global Commitment to Advancing Hepatitis Therapy

Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.

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).



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