Study Shows AIDS Drug VIRAMUNE to be Highly Effective

in Preventing Mother-to-Child HIV Transmission During Labor INGELHEIM/Germany (PROTEXT) - Encouraging preliminary resultsof HIVNET 012, a trial conducted in Uganda by the HIV PreventionTrials Network (HIVNET), demonstrate that VIRAMUNE(R)(nevirapine) can be a safe and effective option in reducing HIVtransmission from mother to child. A simple, inexpensive regimenof one oral dose of VIRAMUNE given to an HIV-infected woman inlabor and another to her newborn within three days of birth wasalmost twice as effective in reducing mother-to-infant HIVtransmission as a similar short course of AZT (ZDV, zidovudine).VIRAMUNE is the first member of a new class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The trialwas sponsored by the U.S. National Institute of Allergy andInfectious Diseases (NIAID). NIAID researchers chose VIRAMUNE for the study because of itspharmacokinetic profile, potency and affordability. VIRAMUNE israpidly absorbed and transferred across the placenta to theinfant and is passed into breast milk. "This study marks a major advance in AIDS and an importantstep in helping control the worldwide epidemic," according toJohn L. Sullivan, MD, Professor of Pediatrics, University ofMassachusetts Medical School, Worcester, an early proponent ofusing VIRAMUNE for the prevention of mother-to-child transmissionof HIV. "These preliminary results suggest that VIRAMUNE may becomethe preferred therapeutic approach in preventing mother-to-infanttransmission of HIV in developing countries," said anotherproponent of this regimen, Professor Joep Lange of the NationalAIDS Therapy Evaluation Centre, Amsterdam. "This news isespecially important to those countries hit hardest by theepidemic, like sub-Saharan Africa, where up to 30 percent ofpregnant women are infected with HIV and up to 25 to 35 percentof infants will be born infected." The United Nations Program on AIDS (UNAIDS) estimates thatapproximately 1,800 HIV-infected babies are born every day indeveloping countries. As NIAID officials say, the presentlyavailable standard of care, AZT or AZT + 3TC (lamivudine), isimpractical for many developing countries because it is expensiveand requires extended prenatal treatment. "We are committed to the continued evaluation of Viramune forthis indication," said Dr. Andreas Barner, member of the Board ofManaging Directors at Boehringer Ingelheim. "We plan to workclosely with the appropriate authorities to expedite theregistration of Viramune, especially in the developingcountries." The role of VIRAMUNE in the prevention of mother-to-childtransmission during labor is also being addressed in otherongoing clinical trials. In April 1999, Boehringer Ingelheim initiated the SAINT studyin South Africa. It will compare the safety and efficacy of asimilar two-dose regimen of VIRAMUNE, versus a combinationregimen of ZDV + 3TC in preventing mother-to-child transmission.Approximately 200 mothers have been enrolled to date. In the United States and Europe, Boehringer Ingelheim isparticipating in a 1,900-patient study (ACTG 316), sponsored byNIAID, which is examining the efficacy of VIRAMUNE in preventingmother-to-child transmission when added to whatever currentantiretrovirals the pregnant women are receiving. This trial hasenrolled more than 700 mothers to date. HIVNET 012 The trial was conducted at Mulago Hospital, affiliated withMakerere University, in Kampala, Uganda by HIVNET, and wassponsored by NIAID. Enrollment was completed last April. Allwomen entered into the study were in their ninth month ofpregnancy and had not taken antiretroviral drugs while pregnant. The study compared the safety and efficacy of two differentshort-course regimens of antiviral drugs administered late inpregnancy. The VIRAMUNE regimen consisted of a single 200 mgtablet given to mothers in labor and a single 2 mg/kg dose ofVIRAMUNE oral suspension to the newborns within 72 hours afterdelivery. The AZT regimen was 600 mg at the onset of labor, 300mg every 3 hours during labor, and 4 mg/kg of AZT twice-daily tothe newborn for the first 7 days after delivery. Both drugsappeared to be safe and well-tolerated. For the interim analysis, the study team looked at data from618 mothers (308 receiving AZT and 310 receiving VIRAMUNE) andtheir infants. VIRAMUNE was markedly more effective. At 14 to 16weeks of age, 13.1 percent of infants who received VIRAMUNE wereinfected with HIV, compared with 25.1 percent of those in the AZTgroup. The mothers and their children will continue to beactively followed until the babies are 18 months old. VIRAMUNE Boehringer Ingelheim recently received approval from theEuropean Commission to market a pediatric formulation of VIRAMUNEto treat infants and children infected with HIV/AIDS. The oralsuspension is currently approved in the U.S., Europe and Mexicoand is awaiting approval in other countries. VIRAMUNE was the first member of the NNRTI class of anti-HIV/AIDS drugs to be approved. VIRAMUNE is indicated for use incombination with other antiretroviral agents for the treatment ofHIV-1 infection. This indication is based on analysis of changesin surrogate end-points, such as viral load or changes in CD4+count. When used in chronic therapy, VIRAMUNE should always beadministered with at least one additional antiretroviral agent.VIRAMUNE tablets were approved for marketing in the U.S. in June1996 and in Europe in February 1998. VIRAMUNE is currentlyapproved in 56 countries. VIRAMUNE is generally well-tolerated. Due to the one singledose regimen of VIRAMUNE in the prevention of perinataltransmission in the HIVNET 012 study, only minor side-effectswere seen. The most commonly reported adverse events associatedwith VIRAMUNE in the long-term combination treatment are rash,fever, nausea, headache and abnormal liver function tests. Severeand life-threatening skin reactions and hepatotoxicity, includingfatal cases of each, have occurred in patients treated withVIRAMUNE. VIRAMUNE is a product of original research conducted atBoehringer Ingelheim Pharmaceuticals, Inc., a member of theBoehringer Ingelheim group of companies. VIRAMUNE is marketedworld-wide by Boehringer Ingelheim and in the United States byRoxane Laboratories, also a member of the Boehringer Ingelheimgroup of companies. Boehringer Ingelheim, headquartered in Ingelheim, Germanyranks among the top 20 pharmaceutical companies in the world. Itreported revenues exceeding DM 8.75 billion in 1998. Thecorporation has some 140 affiliated entities and it conductsbusiness on every continent. Its product range is focused onhuman pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health. The company has substantial research and development,production and distribution facilities around the globe. In 1998Boehringer Ingelheim spent DM 1.6 billion on research anddevelopment, equivalent to 18% of total sales. ots OriginalText Service: Boehringer Ingelheim GmbH Internet:http://www.newsaktuell.de CONTACT: Ulrich Bock, CorporatePublic Relations Division of Boehringer Ingelheim GmbH, + 49-6132-772012, or fax, + 49-6132-776601; or Maureen Byrne, 212-886-3312 or Denise Connolly, 212-886-3117 of GCI Healthcare, orfax,212-886-3291, for Boehringer Ingelheim/

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