Abbott Laboratories

European Committee for Proprietary Medicinal Products Adopts Positive Option For Kaletra(TM) for the Treatment of HIV

    Abbott Park, Ill. (ots-PRNewswire) - Abbott Laboratories today announced that the Committee for Proprietary Medicinal Products (CPMP) in the European Union has adopted a positive opinion on Kaletra(TM) (lopinavir/ritonavir), previously known as ABT-378/r. Kaletra is an advanced-generation protease inhibitor (PI) indicated for the treatment of HIV infection in adults and children above the age of 2 years. The CPMP opinion will be considered by the European Commission, which will make the final decision regarding marketing authorization, a process that takes approximately 90 days.

    "The positive opinion is a major step forward in bringing Kaletra to patients in Europe," said David Goffredo, vice president, European operations, Abbott Laboratories. "Clinical data demonstrates that Kaletra provides effective, durable and tolerable therapy, and we look forward to the opportunity to make Kaletra available to people with HIV."

    The CPMP positive opinion of Kaletra, which was granted under exceptional circumstances, was based on results from a 24-week controlled Phase III clinical trial and additional smaller Phase II trials. For serious illnesses where patients need access to new medications, the CPMP will adopt a positive opinion under exceptional circumstances based on data from ongoing studies. Longer-term data from these studies were presented at the recent Fifth International Congress on Drug Therapy in HIV Infection in Glasgow, UK, on Oct. 22-25, 2000.

    Kaletra's Long-Term Effectiveness as a First-Line PI

    In a Phase III, double-blind, ongoing international clinical study comparing two protease inhibitors, Kaletra was shown to be more effective than nelfinavir, the most widely prescribed PI, at reducing HIV viral levels after 48 weeks of treatment in patients new to HIV therapy. A separate ongoing Phase II study of Kaletra in patients new to HIV therapy showed that Kaletra provides durable, tolerable therapy after more than two years (108 weeks) of treatment.

    Lack of Resistance Development to Kaletra in Clinical Trials

    An analysis of resistance data from three studies of Kaletra shows that no genotypic resistance has been observed to date in more than 450 patients new to HIV therapy in clinical trials. This analysis includes data from two 48-week studies and one study of more than two years duration. Genotypic testing examines a viral sample for specific mutations, or changes, in the virus that are known to cause resistance to certain drugs. Viral resistance is one of the main causes of viral rebound and subsequent treatment failure for people with HIV.

    Kaletra's Effectiveness in a Broad Spectrum of Patients

    In addition to its demonstrated efficacy in patients new to HIV therapy, Kaletra has provided effective viral suppression in a broad spectrum of patients with HIV, including treatment-naive and treatment-experienced adults and children. In an ongoing Phase II pediatric trial in 100 children, Kaletra continued to provide effective, tolerable treatment after nearly one year (48 weeks) of therapy, with only two patient discontinuations. In addition, two separate Phase II studies of Kaletra combined with non-nucleoside reverse transcriptase inhibitors (NNRTIs) show good viral suppression in patients who had previously been treated with one or more PIs.

    The most commonly reported, Kaletra-related adverse events were abdominal pain, abnormal stools, diarrhea, feeling weak or tired, headache, nausea and vomiting.

    Based on the urgent need for new treatment options, Abbott initiated its Early Access Program prior to regulatory submission and market authorization to provide Kaletra to HIV-positive patients who do not have other viable treatment options.  The program was designed by working closely with key regulatory agencies and representatives of several HIV treatment organizations and currently is available to more than 13,000 patients in more than 30 countries worldwide, including 19 countries in Europe. Abbott will continue to provide Kaletra to patients in the countries participating in the program until Kaletra is available with a prescription to ensure patients will have continued, uninterrupted access to Kaletra.

    Abbott Laboratories has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood, and remains the leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With Kaletra, Abbott has developed two protease inhibitors, and also offers nutritional products that meet the unique dietary needs of people living with HIV.

    Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 60,000 people and markets its products in more than 130 countries. In 1999, the company's sales and net earnings were $13.2 billion and $2.4 billion, respectively, with diluted earnings per share of $1.57.

    Abbott 's news releases and other information are available on the company's Web site at .

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