18/07/2011 — WHITEHOUSE STATION, N.J. — (BUSINESS WIRE)

MSD (NYSE: MRK), known as Merck in the United States and Canada, today announced that the European Commission (EC) has approved VICTRELIS® (boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated 4 million people in Europe.

The European Commission’s Decision grants a single marketing authorisation that is valid in the 27 countries that are members of the European Union (EU), as well as unified labeling applicable to the European Economic Area members, Iceland, Liechtenstein and Norway.

“The EU approval of VICTRELIS for chronic hepatitis C genotype 1 is very exciting, because we now have a new option for patients with the hardest to treat form of the disease. With VICTRELIS, patients who have failed previous therapy or are new to treatment can significantly improve their chances of achieving a virological cure compared to current standard therapy,” said Rafael Esteban, M.D., head of the internal medicine and liver unit of the Hospital Universitario Val d’Hebron, Barcelona, Spain. “For some patients new to treatment, VICTRELIS also may allow for a shorter total duration of therapy.”

VICTRELIS is the first in a new class of medicines known as HCV protease inhibitors. It is a Direct Acting Antiviral (DAA) agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease). Current standard therapy for HCV works to strengthen the body’s natural immune response to the virus, but a majority of patients with chronic hepatitis C genotype 1 are not able to achieve a sustained virological response (SVR).1

“VICTRELIS is the first major advancement for the treatment of chronic hepatitis C approved in the EU in a decade, and represents an important step forward for people living with this serious disease and the physicians who treat them,” said Bruno Strigini, president, Europe/Canada, Merck. “Recognizing the high unmet need in this area, MSD will work closely with local authorities across the EU to make VICTRELIS available to patients as quickly as possible.”

The marketing authorisation for VICTRELIS in combination with current standard therapy is based on the efficacy and safety results from two large pivotal Phase III clinical studies conducted at European and North American sites that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection who were previously untreated or who had failed prior therapy. Both studies included two treatment arms with VICTRELIS: a response-guided therapy (RGT) arm, in which patients with undetectable virus (HCV-RNA) at treatment week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm. All patients receiving VICTRELIS in these studies were first treated with peginterferon alfa-2b and ribavirin (P/R) in a 4-week lead-in phase, followed by the addition of VICTRELIS after week 4. The studies also included a control arm in which patients received 48 weeks of treatment with P/R alone. Final results of the HCV SPRINT-2 (treatment-naïve) study and the HCV RESPOND-2 (treatment-failure) study were published in the New England Journal of Medicine on March 31, 2011.

The safety profile of VICTRELIS was based on pooled safety data from the two pivotal Phase III clinical studies. The most common adverse events seen in patients treated with VICTRELIS were fatigue, anaemia, nausea, headache and dysgeusia (taste disturbance). The most common reason for dose reduction was anaemia, which occurred more frequently in patients receiving the combination of VICTRELIS with P/R than in patients receiving P/R alone. Anaemia was observed in 49 percent of patients treated with VICTRELIS in combination with P/R, compared with 29 percent of patients treated with P/R alone. VICTRELIS was associated with an additional decrease of approximately 1 g/dl in haemoglobin concentration.

For complete prescribing information, please visit www.emea.europa.eu.

MSD’s global commitment to advancing hepatitis therapy

MSD 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 with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.

About MSD

Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. 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.msd.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).

1SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient’s 12-week post-treatment assessment was utilized.

VICTRELIS® is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.

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