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Boehringer Ingelheim and GlaxoSmithKline to develop co-package of Viramune® and Combivir® for the developing world

Pressmeddelande   •   Jul 12, 2004 12:39 CEST

Ingelheim/Germany, London/UK and Philadelphia/US, 12 July 2004 - Boehringer Ingelheim and GlaxoSmithKline plc (GSK) announced today that the companies have signed a letter of intent for an accelerated development programme for a co-package for Viramune® (nevirapine) and Combivir® (lamivudine/zidovudine) for chronic treatment of HIV infection in the developing world. Given the complexities of providing HIV care and treatment in the developing world, Boehringer Ingelheim and GSK support efforts to simplify treatment regimens and improve access to antiretrovirals (ARV) to people living with HIV.

Boehringer Ingelheim and GSK have initiated contacts with the US Food & Drug Administration (FDA) on development of the co-package under the new draft FDA guidance1 designed ultimately to increase treatment options for HIV in the developing world. The availability of the Viramune-Combivir co-package is contingent upon approval by appropriate regulatory authorities and execution of a definitive agreement.

"The co-package of Viramune and Combivir is the most expeditious strategy for facilitating access to HIV treatment in the developing world. In practice, the Viramune- Combivir co-package will facilitate distribution and delivery of a recognised triple therapy to patients in need." said Dr. Alessandro Banchi, Chairman of the Board of Managing Directors at Boehringer Ingelheim.

"We have made substantial progress with our strategy to co-package Combivir and Viramune," said Lynn Marks, MD, Senior Vice President of Infectious Diseases, GlaxoSmithKline. "We continue our commitment to address the HIV/AIDS challenges in the developing world. Both companies believe that patients can benefit from a co-package that simplifies treatment.”

The Viramune and Combivir combination regimen is a well-established, safe and effective treatment for HIV. This combination is recommended by the World Health Organization as a first-line regimen in its treatment guidelines for developing countries published in December 2003.

About Viramune
Viramune (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on a principle clinical trial that demonstrated prolonged suppression of HIV-RNA and on two smaller supportive studies. The most clinically important adverse events associated with Viramune are rash and hepatic events, which have included fatal cases. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.

About Combivir
Combivir is a combination tablet containing Epivir® (lamivudine, 3TC) and Retrovir® (zidovudine, AZT). Combivir is indicated in combination with other antiretroviral agents for the treatment of HIV infection. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, especially in advanced HIV disease, and with symptomatic myopathy after prolonged use. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine, which is one component of Combivir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Combivir and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted. Redistribution/accumulation of body fat has been observed in patients receiving anti-retroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown. The most frequent adverse events are headache (35%), nausea (33%), malaise/fatigue (27%), and nasal signs and symptoms (20%).

HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

About Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Viramune® (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Boehringer Ingelheim is committed to the rapid development of the investigational non-peptidic protease inhibitor (NPPI) tipranavir in phase III clinical trials. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.

About GlaxoSmithKline
GlaxoSmithKline is one of the world`s leading pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK is a leader in bringing HIV/AIDS treatments to patients, and provides its anti-retrovirals to 63 of the least developed countries and Sub-Saharan Africa at not-for-profit prices.

Related links:
HIV/Aids Website Boehringer Ingelheim
Global website of GlaxoSmithKline

Boehringer Ingelheim GmbH
Corporate Division Communications
Julia Meyer-Kleinmann
55216 Ingelheim am Rhein
Phone: +49/6132/77 82 71
Fax: +49/6132/77 66 01