WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck’s investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
“The positive recommendation brings us one step closer to bringing VICTRELIS to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C”
The committee’s recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.
“The positive recommendation brings us one step closer to bringing VICTRELIS to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories. “We’re pleased with the panel’s decision and look forward to working with the FDA as it continues to evaluate the application for VICTRELIS.”
The FDA granted priority review status for VICTRELIS, a designation for investigational medicines that address unmet medical needs. Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for VICTRELIS for accelerated assessment.
The panel reviewed the results from the Phase III clinical study program for VICTRELIS; the clinical trials HCV SPRINT-2 and HCV RESPOND-2 included approximately 1,500 patients with chronic HCV genotype 1 infection, the most common form of the virus in the United States and most difficult to treat. Data that were discussed involved 1,097 treatment-naïve patients (HCV SPRINT-2) and 403 patients who failed previous therapy (HCV RESPOND-2). HCV SPRINT-2 included a separate analysis of results in African-American patients, a patient population that typically does not respond well to standard therapy. Results from HCV SPRINT-2 and HCV RESPOND-2 were published in the March 31 issue of the New England Journal of Medicine.
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. Extensive research efforts are underway to develop oral therapies that bring innovation to 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.
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 2010 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: Pamela Eisele, 908-423-5042 Robert Consalvo, 908-295-0928 or Investors: Joe Romanelli, 908-423-5088 Carol Ferguson, 908-423-4465
