First NNRTI Suspension, VIRAMUNE(R), Now Available for

Boehringer Ingelheim announced today that it has received approval from the European Commission to market a paediatric formulation of the AIDS drug VIRAMUNE(R) (nevirapine) to treat infants and children infected with HIV. VIRAMUNE is the first oral suspension belonging to the class of drugs called NNRTIs, or non-nucleoside reverse transcriptase inhibitors, to be approved in the European Union (EU) for use in combination therapy for the treatment of paediatric HIV/AIDS. "VIRAMUNE's paediatric formulation broadens the therapeutic options for HIV-positive children, particularly for those children who are in need of new treatment options due to intolerable dosing and side effects or resistance," said John L. Sullivan, MD, Professor of Pediatrics, University of Massachusetts Medical School, Worcester, and one of the lead investigators for the paediatric formulation. "Some of the currently available agents are very effective, but taste terrible; therefore getting kids to swallow such drugs is very difficult. VIRAMUNE, in comparison, is a pleasant-tasting liquid suspension administered twice daily. We have found that VIRAMUNE is easy for children to take and is generally well tolerated." According to the December 1998 United Nations Joint Programme on AIDS (UNAIDS)/World Health Organisation (WHO) report on the global AIDS epidemic, over 770,000 children in Europe and Central Asia under the age of 15 are infected with HIV/AIDS, and young people (aged 15-24) accounted for nearly half of all new HIV infections in 1998. VIRAMUNE's paediatric suspension marks the seventh agent to be approved to treat HIV in paediatric patients in the EU. There are currently 12 available agents for adults. "We're pleased that VIRAMUNE's paediatric formulation is now available in Europe," said Professor Rolf Krebs, Vice Chairman of the Board of Managing Directors responsible for the Division Pharma at Boehringer Ingelheim. "Research has shown that Viramune is a potent and safe agent for treating children and adolescents infected with HIV." "Boehringer Ingelheim is committed to the ongoing study of VIRAMUNE in children and adults, as well as to pursuing other treatments that could benefit the HIV community," commented Professor Krebs. Efficacy and Safety To date, more than 360 children as young as two months old have been treated with VIRAMUNE in clinical trials. Some have remained on therapy for as long as six years. VIRAMUNE has been shown to suppress HIV-1 in adults when used in combination with other antiretrovirals. The European Commission's approval is based on data from several clinical trials. In AIDS Clinical Trial Group (ACTG) 180 (BI 1100.882), a multicenter, open-label study, paediatric patients with six weeks or less of prior nucleoside therapy were treated with VIRAMUNE monotherapy, double therapy with VIRAMUNE/AZT (Retrovir(R), zidovudine, ZDV), or triple therapy with VIRAMUNE/AZT/ddI (Videx(R), didanosine) for 28 to 32 weeks. Patients receiving triple therapy (VIRAMUNE/AZT/ddI) maintained a median decrease of greater than two logs below baseline in HIV- RNA for eight weeks (7 of 8 achieved a nadir of at least 1.6 logs). Durable suppression of HIV-1 replication was observed over six months of therapy in the majority of infants and children studied. Complete control of HIV replication was achieved in two infants who began triple therapy at 2.5 months of age. In these subjects, HIV-1 RNA became undetectable in the plasma and the active production of antibodies was not observed. In the majority of patients in all three treatment groups, the percentage of infection-fighting CD4+ cells remained stable or increased through 32 weeks of treatment. The study findings were published in The New England Journal of Medicine in May 1997. VIRAMUNE continues to be studied in ongoing paediatric clinical trials. Preliminary results of ACTG 356, in which patients took a combination of VIRAMUNE/AZT/3TC (Epivir(R), lamivudine), were presented at the Fifth Conference on Retroviruses and Opportunistic Infections in February 1998. Also presented were results of ACTG 245, a double-blind, randomized, placebo- controlled trial of 431 children with advanced HIV disease. Overall, 40 percent of the children who were treated with a triple therapy regimen of VIRAMUNE/AZT/ddI met the protocol-defined definition of virologic responders compared to 14 percent of those just on AZT/ddI and eight percent taking only VIRAMUNE/ddI. Adverse event data for nevirapine-treated patients aged two months to 19 years indicate that VIRAMUNE is generally safe and well tolerated. Overall, in children and adults, the most commonly reported adverse events associated with VIRAMUNE are rash, fever, nausea, fatigue, headache, somnolence, vomiting, diarrhoea, abdominal pain, myalgia and abnormal liver function tests. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with VIRAMUNE. Granulocytopoenia is a paediatric specific adverse event. Dosing Recommended paediatric dosing for VIRAMUNE is 4 mg/kg once- daily suspension for two weeks, followed by 7 mg/kg twice-daily for children between two months and eight years of age, and 4 mg/kg twice-daily for children eight years and older. The total daily dose should not exceed 400 mg (200 mg twice-daily) suspension for any patient. VIRAMUNE can be taken with or without food. VIRAMUNE tablets were approved for marketing in the EU in February 1998 and have been used in more than 60,000 adult patients world-wide. VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or changes in CD4+ cell count. VIRAMUNE should always be administered in combination with at least one additional antiretroviral agent. VIRAMUNE is a product of original research conducted 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, headquartered in Ingelheim, Germany, ranks among the top 20 pharmaceutical companies in the world. It reported revenues exceeding DM 8.75 billion in 1998. The corporation has some 140 affiliated entities and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self- medication -- as well as animal health and industrial biopharmaceuticals. The company has substantial research and development, production and distribution facilities around the globe. In 1998 Boehringer Ingelheim spent over DM 1.5 billion on research and development, equivalent to 18 percent of total sales. ots Original Text Service: Boehringer Ingelheim Internet: Contact: Judith von Gordon of Boehringer Ingelheim GmbH, 49-61-32-77-35-82, or fax, 49-61-32- 77-66-01; or Maureen Byrne of GCI Healthcare, USA, 212-886-3312, or fax, 212-886-3291. For more information about ACTG 180, 245 or ACTG 356, please call 212-886-3312


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