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ISENTRESS(R) (raltegravir) from MSD, First Integrase Inhibitor, Approved by the European Union Commission
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Friday December 21, 6:49 am ET
First-in-Class Therapy Addresses Medical Need for New Treatment Options in Treatment-Experienced Patients
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck Sharp & Dohme (MSD) announced today that ISENTRESS (raltegravir) has been granted a license from the European Union Commission (Commission) by way of a decision for use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy (ART). The Commission's decision is applicable to the 27 Member States of the European Union (EU), including France, Germany, Italy, Spain and the United Kingdom. Separate national licenses, based on the Commission's Decision, will also be issued in European Economic Area Member States Iceland and Norway. Raltegravir is the first approved integrase inhibitor, a new class of ART that works by targeting the integrase enzyme, which is essential for HIV replication.
The Commission's decision, reflecting the positive opinion of the European Medicines Agency, was based on efficacy and safety data from two double-blind, placebo-controlled trials of 24 weeks duration in treatment-experienced patients. In these studies raltegravir, in combination with optimised background therapy (OBT), significantly reduced HIV RNA viral load (p<0.001), and significantly increased CD4 cell counts (p<0.001). The efficacy and safety of raltegravir have not been established in treatment-naive adult patients or paediatric patients, although studies in these populations are underway.
"Raltegravir is an important new advancement in the treatment of HIV, because it is the first therapy in a new class of drugs that attacks the virus in a completely different way from other available medicines," said Ken Frazier, executive vice president and president, Global Human Health, Merck & Co., Inc. "This approval marks another milestone in MSD's continued commitment to combating HIV and AIDS by conducting research for breakthrough medicines, developing business models that help our products reach as many people as possible, and participating in partnerships to help build infrastructure and address health and development challenges around the world."
Despite the availability of drugs to treat HIV and AIDS, the pandemic continues. In the EU, nearly 250,000 cases of HIV have been reported since 2002, according to the European Centre for the Epidemiological Monitoring of HIV and AIDS. Additionally, resistance to current HIV therapies in treatment-experienced patients has been noted in numerous international studies, suggesting that resistance to at least one class of antiretroviral agents may be as high as 76 percent. The World Health Organisation (WHO) has called resistance an emerging public health concern and has partnered with the International AIDS Society to develop the Global HIV Drug Resistance Surveillance Network to track emerging resistance patterns in developing and developed countries.
"Treatment-experienced HIV patients have limited options for therapies that are well-tolerated and can reduce viral loads while boosting CD4 counts," said Jurgen Rockstroh, professor of medicine and head of the HIV Outpatient Clinic, University of Bonn, Germany. "The approval of raltegravir in the EU represents a significant scientific advancement, but more importantly, it addresses a much-needed evolution in the treatment of HIV and AIDS."
Reduction in viral load and increase in CD4 cell counts
Raltegravir is being studied in two ongoing Phase III multi-centre, double-blind, randomised, placebo-controlled studies (BENCHMRK-1 and BENCHMRK-2) in 699 treatment-experienced adult patients with documented resistance to at least one drug in each of three classes [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] of ARTs. Raltegravir 400 mg taken twice daily in combination with OBT was significantly (p<0.001) more effective at both reducing levels of HIV RNA and increasing CD4 cell counts in these patients, when compared to a regimen of placebo plus OBT. The efficacy responses were evaluated based upon the 699 patients from the pooled studies who had completed 24 weeks of treatment or discontinued earlier.
The studies showed that after 24 weeks of therapy, 75 percent of patients (347 out of 462) receiving raltegravir in combination with OBT achieved HIV RNA load reduction to below 400 copies/mL, compared to 40 percent of patients (95 out of 237) receiving placebo plus OBT. In addition, after 24 weeks of therapy, 63 percent of patients (289 out of 462) receiving raltegravir plus OBT achieved viral load reduction to below 50 copies/mL, compared to 34 percent of patients (80 out of 237) receiving placebo plus OBT. After 24 weeks of therapy, increases in CD4 cell counts from baseline were 84 and 37 cells/mm3 for patients receiving raltegravir plus OBT and for those receiving placebo plus OBT, respectively.
Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir. In Phase II and III clinical trials, the side effect profile was comparable with placebo. The most common side effects are diarrhoea, nausea, headache and pyrexia.
About raltegravir
Raltegravir is the first in a new class of antiretroviral agents called integrase inhibitors. Raltegravir works by inhibiting the insertion of the HIV DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit the other two enzymes critical to the HIV replication process - protease and reverse transcriptase - but raltegravir is the only drug approved that inhibits integrase.
Global filing status of raltegravir
Earlier this year, raltegravir received approval in the United States, Mexico and Canada, and MSD is also moving forward with filings in many countries around the world.
MSD history in HIV research
MSD is committed to developing innovative therapies that offer advances in the treatment of infectious diseases - including HIV. MSD's efforts to develop investigational treatments for HIV have been under way for more than 20 years and continue today. MSD began its HIV integrase inhibitor research in 1993, and MSD was the first to demonstrate inhibition of HIV integrase in vitro and in vivo.
Raltegravir is one part of MSD's history in HIV research, which includes the development of CRIXIVAN (indinavir sulfate), a PI; STOCRIN, a NNRTI; and research is currently underway on additional treatment options.
Global prevalence of HIV and AIDS
An estimated 33 million people are living with HIV and AIDS worldwide, and more than 2.5 million new infections occurred worldwide in 2007.i AIDS is one of the top causes of infectious disease-related mortality worldwide, responsible for more than two million deaths last year alone.ii
About MSD
Merck & Co., Inc., Whitehouse Station, N.J., U.S.A. which operates in many countries as MSD (Merck, Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, MSD currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programmes that not only donate MSD medicines but help deliver them to the people who need them. MSD also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. MSD undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect MSD's business, particularly those mentioned in the cautionary statements in Item 1A of MSD's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
i UNAIDS. 2007 AIDS Epidemic Update. Available at:
www.unaids.org/en/HIV_data/2007EpiUpdate/default.asp. Accessed on 28 November 2007.
ii World Health Organization. The global burden of disease: a response to the need for comprehensive, consistent and comparable global information on diseases and injuries. Available at:
www.who.int/mip/2003/other_documents/en/globalburdenofdisease.pdf . Accessed on 26 November 2007.
Contact:
Merck & Co., Inc.
Media:
Amy Rose, +1 908-423-3786
Lynn Kenney, +1 908-423-4188
or
Investors:
Graeme Bell, +1 908-423-5185
Source: Merck & Co., Inc.
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