Merck Signs Two Deals for Novel HIV Drug Candidates and Initiates Phase II Clinical Trial of MK-1439 for HIV

Merck remains committed to advancing treatment for people with HIV

WHITEHOUSE STATION, N.J.--()--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has signed two licensing agreements for investigational HIV drug candidates. Additionally, the company announced plans to initiate a Phase II study for a proprietary investigational next generation non-nucleoside reverse transcriptase inhibitor, MK-1439.

"Despite the tremendous advances made over the past 20 years, there remains considerable unmet need in the treatment of HIV infection," said Robin D. Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. "Merck remains committed to improving on the standard of care for HIV therapy."

Merck signed a deal with Chimerix Inc. based in Research Triangle Park, NC, for CMX157, an investigational oral nucleoside reverse transcriptase inhibitor currently in Phase I clinical development. Under the agreement, Merck will receive an exclusive worldwide license and will be responsible for development and commercialization of CMX157.

Separately, the company signed an agreement with Yamasa Corporation based in Choshi, Japan, to develop EFdA (4’-ethynyl-2-fluoro-2’-deoxyadenosine), a novel nucleoside reverse transcriptase inhibitor candidate that is in preclinical studies and has shown antiviral activity toward highly resistant HIV strains. As part of the agreement, Merck will pay an up-front fee and future milestone payments in return for exclusive worldwide license rights. This candidate was discovered in collaboration with a group led by the world renowned HIV research scientist Dr. Hiroaki Mitsuya of Kumamoto University’s Center for AIDS Research in Japan.

In addition, Merck announced plans to advance into Phase IIb clinical trial an internally developed candidate, MK-1439, a next-generation non-nucleoside reverse transcriptase inhibitor. Merck is initiating a dose-ranging clinical trial to evaluate the safety and tolerability and efficacy of MK-1439 in HIV positive, treatment-naive patients compared to efavirenz, both in combination with Truvada. The trial is expected to commence in September. More information is available at http://clinicaltrials.gov/ using Identifier: NCT01632345.

Merck's history in HIV research and access

Merck has been engaged in the fight against HIV/AIDS for more than two decades. In 1988, Merck researchers were the first to demonstrate that inhibiting the protease enzyme would prevent replication of HIV; the following year, Merck scientists published the first crystal structure for HIV protease. Years later, Merck scientists were the first to demonstrate inhibition of HIV integrase in vitro and in vivo. Currently Merck scientists are actively pursuing HIV research against at least five distinct targets and have several HIV compounds in development. Since our first HIV medicines became available, Merck has worked to expand access to these medicines, including through partnerships with others.

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 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 U.S. 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 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).

Contacts

Merck
Media:
Ian McConnell, 908-423-3046
Investors:
Carol Ferguson, 908-423-4465

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Contacts

Merck
Media:
Ian McConnell, 908-423-3046
Investors:
Carol Ferguson, 908-423-4465