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Boceprevir (Victrelis) Approved in Europe

Hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis) received approval from the European Commission, Merck announced this week.

Boceprevir is one of the first direct-acting agents approved for the treatment of chronic hepatitis. It and another protease inhibitor, telaprevir (Incivek) were approved in the U.S. in May.

Below is an edited excerpt from a Merck press release describing the European approval.

Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus Protease Inhibitor, Approved in the European Union for Treatment of Chronic Hepatitis C

Whitehouse Station, N.J. -- July 18, 2011 -- Merck (NYSE: MRK), known as MSD outside 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 authorization 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 clearing the virus from their bodies compared to current standard therapy," said Rafael Esteban, MD, 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 virologic response (SVR).

“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, Merck will work closely with local authorities across the EU to make Victrelis available to patients as quickly as possible.”

The marketing authorization 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 Medicineon March 31, 2011.

Victrelis in the United States

Victrelis was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.

Victrelis is indicated in the U.S. for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating Victrelis for treatment of chronic hepatitis C infection:

Victrelis must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.

Victrelis efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.

Victrelis in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 logHCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 logHCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.

Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.

The full press release, including important safety information, is available online.

Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.

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 with VICTRELIS, 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.

7/20/11

Sources

Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus Protease Inhibitor, Approved in the European Union for Treatment of Chronic Hepatitis C. Press release. July 18, 2011.