Abbott Laboratories

Abbott Laboratories Raises Awareness of Expansion of Kaletra(TM) (Lopinavir/Ritonavir) Early Access Program
Abbott Lifts Criteria for Patients to Enroll in Program

    Abbott Park, Ill. (ots-PRNewswire) - Abbott Laboratories' (NYSE: ABT) Kaletra, formerly ABT-378/r, Early Access Program now has availability for more patients. Kaletra is Abbott's investigational HIV protease inhibitor currently in Phase III clinical trials. In January, Abbott expanded its Early Access program criteria to allow additional access to Kaletra to any HIV+ patient for whom Kaletra is necessary to construct a viable regimen, without CD4 cell count or viral load restrictions. Previously, the Early Access program was limited to those patients who met select entry criteria to best manage a limited drug supply.

    "We are committed to providing access to Kaletra to as many patients as possible who need it to construct a viable regimen," said Eugene Sun, M.D., head of antiviral drug development at Abbott Laboratories.

    In order to best meet the needs of people with advanced HIV, Abbott Laboratories worked closely with key regulatory agencies and representatives of several HIV treatment advocacy organizations to design its Kaletra Early Access program. Often referred to as expanded access, early access programs are part of a collaborative effort by the pharmaceutical industry, HIV treatment advocates and government health agencies to make investigational compounds available to patients in advance of  regulatory submission or approval.

    The Kaletra Early Access program is currently under way in 21 countries, and 6,100 patients are enrolled in the program, worldwide. Individuals interested in receiving Kaletra through early access should speak with their healthcare provider or call 1-888-711-7193 in the United States and Canada. Physicians who wish to request registration materials or additional information can call the same number.

    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 in the blood. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. Abbott has developed a protease inhibitor and Ensure(R), an oral nutritional supplement to assist patients with involuntary weight loss, often a symptom of HIV.

    Abbott continues to conduct aggressive research to fight HIV and AIDS. Most recently, Abbott entered into a strategic alliance with Triangle Pharmaceuticals (Nasdaq: VIRS). This agreement provides Abbott and Triangle with the opportunity to develop promising drug therapies.

    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 57,000 people and markets its products in more than 130 countries.

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