Boehringer Ingelheim Offers VIRAMUNE® (nevirapine) Free of Charge to Developing Economies for the Prevention of HIV-1 Mother-to-child Transmission

07  July 2000

Ingelheim, 7 July 2000 – Boehringer Ingelheim announced today that VIRAMUNE® will be offered free of charge for a period of five years for the prevention of mother-to-child transmission (MTCT) of HIV-1 in developing economies.

This initiative is part of Boehringer Ingelheim’s commitment to the collaborative effort with five companies (Boehringer Ingelheim, Bristol-Myers Squibb, F. Hoffman-La Roche, Glaxo Wellcome and Merck & Co., Inc.), United Nations agencies (World Health Organisation (WHO), World Bank, UNICEF, UNFPA and UNAIDS) and committed governments to explore practical ways of working together to make HIV/AIDS care available and affordable to a significantly greater number of people in developing countries.

“VIRAMUNE® can fill a critical need in the developing world,” said Prof Rolf Krebs, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim. “We hope that our initiative for the prevention of mother-to-child transmission will help make an impact on the HIV/AIDS epidemic.”

A recent publication in the June 17 issue of The Lancet presents hope for reducing newborn HIV infections in the developing world.1 Findings indicated that antiviral intervention can have a significant impact on the prevention of MTCT. Researchers projected that if all pregnant women in South Africa took a short course of antiretroviral medication during labor, as many as 110,000 infant HIV infections could be prevented over the next five years.

Authors of The Lancet article cited that a single dose of VIRAMUNE® to mother-baby pairs is likely the most cost effective, efficacious and most easily administered antiretroviral agent for the prevention of MTCT to date. Researchers have been investigating the drug since 1997 for this important use. The outcome of these investigations encouraged the WHO to place VIRAMUNE® on its Model List of Essential Drugs for MTCT in December 1999.

“Viramune®, which has been studied in women in Uganda and South Africa, holds great promise for reducing mother-to-child HIV transmissions in the developing world because it represents a short and simple regimen, which can be easily administered in a resource-poor environment,” said Dr. Brooks Jackson, principal investigator, HIVNET 012, Johns Hopkins University, Baltimore.

Boehringer Ingelheim will adhere to the WHO guidelines for drug donations to ensure that VIRAMUNE® is donated to the developing countries with the greatest need. The WHO guidelines require that donations be based on an expressed need by the country in question. Further, donations must be relevant to the needs of the recipient country. Boehringer Ingelheim will rely on interested local governments that approve the use of VIRAMUNE® in MTCT and global organisations, such as UNAIDS, UNICEF and the WHO to optimise existing infrastructures so that safe and proper administration of VIRAMUNE® is possible.

Boehringer Ingelheim will make every effort to see that VIRAMUNE® is available in every country around the world. VIRAMUNE® has now been registered in more than 75 countries and registration packages have been submitted in almost every country worldwide.

“Providing Viramune® is only one component of making prevention of HIV-1 mother-to-child transmission possible in the developing world,” said Prof. Krebs. “However, a successful program to reduce MTCT of HIV entails additionally education of mothers and health service personnel, testing for infection, and counseling of infected mothers-to-be.”

VIRAMUNE® was shown to be a well-tolerated and effective option for the prevention of MTCT in the Ugandan HIVNET 012 trial.2 The study was published in the September 4, 1999 issue of The Lancet and demonstrated that a simple regimen of one oral dose of VIRAMUNE® given to an HIV-infected mother in labour and another dose to her newborn within three days of birth was almost twice as effective in reducing MTCT as a short course of zidovudine (AZT).

To date about 1700 mothers and babies have been treated with the simple one-dose treatment regimen of nevirapine in MTCT and no safety concerns have been raised. While there are still scientific questions to be answered, the overwhelming opinion of experts is strongly in favour of treatment.

The company acknowledges the importance of continued research into the role of VIRAMUNE® in preventing MTCT. Boehringer Ingelheim is sponsoring the SAINT study, a large, multicenter trial designed to further evaluate the safety and efficacy of two doses of VIRAMUNE® compared to a weeklong regimen of two drugs, ZDV+3TC, in reducing MTCT. Preliminary results of this study, as well as twelve-month HIVNET 012 data, will be presented at the 13th International AIDS Conference in Durban, South Africa (9 – 14 July).

A critical area of research into the prevention of MTCT is the extent to which HIV is transmitted during breastfeeding. Healthy babies born to HIV-infected mothers may contract HIV through breastmilk. This risk appears to be highest in the early months of breastfeeding.3

Another critical area of research is the development of drug resistance after treatment. An abstract presented at the 7th Conference on Retroviruses and Opportunistic Infections (HINVET 006) suggests that a minority of patients may develop resistance to VIRAMUNE® after a single dose.4 At least in some patients this resistance is transient.5 Further studies are evaluating the clinical relevance of these findings.

VIRAMUNE® has been investigated for the MTCT indication because of its potency, pharmacokinetic profile and affordability. VIRAMUNE® is rapidly absorbed and transferred across the placenta to the infant and is passed into breast milk. VIRAMUNE® can be stored at room temperature, an important consideration in developing countries.

VIRAMUNE® is registered for the chronic treatment of HIV-1 infection in combination with other antiretroviral agents. Major adverse events associated with VIRAMUNE® in the treatment of chronic HIV infections are rash and increases in liver function enzymes. Hypersensitivity reactions have also been observed. Severe and life-threatening skin reactions and hepatotoxicity, with fatal outcome, have occurred in chronically infected HIV patients treated with VIRAMUNE®.

VIRAMUNE® was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs to be approved for combination HIV therapy. VIRAMUNE®’s approval is based on analysis of changes in surrogate end-points, such as reduction in viral load or increases in CD4+ cell count. VIRAMUNE® should always be administered in combination with other antiretroviral agents.

VIRAMUNE® is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., a member of the Boehringer Ingelheim group of companies. VIRAMUNE® is marketed world-wide by Boehringer Ingelheim and in the United States by Roxane Laboratories, also a member of the Boehringer Ingelheim group of companies. Boehringer Ingelheim recently acquired world-wide marketing rights to an additional anti-HIV drug, an investigational protease inhibitor, tipranavir.

Boehringer Ingelheim has focused a number of years on HIV drug research to prevent new infections and to treat HIV-infected people around the world. In addition to high investments in research and development and sponsoring initiatives (such as to the Elizabeth Glaser Pediatric AIDS Foundation), Boehringer Ingelheim supports training initiatives for the developing world as a partner of the IAS-SHARE Treating Program for Physicians.

For more information on Boehringer Ingelheim or VIRAMUNE®, please see www.boehringer-ingelheim.com.