Norvir Granted Scientific Approval by the CPMP for HIV Infection
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Norvir Granted Scientific Approval by the CPMP for HIV Infection

ABBOTT PARK, Ill., May 24, 1996 -- The European Agency for the Evaluation of Medicinal Products (EMEA) has granted within its scientific Committee for Proprietary Medicinal Products (CPMP) a positive scientific opinion on the granting of a European marketing authorization to Abbott's HIV protease inhibitor Norvir (ritonavir) for use in combination with antiretroviral nucleoside analogues for the treatment of HIV-infected adult patients with advanced or progressive immunodeficiency. Norvir is the first HIV protease inhibitor to receive a scientific approval by the CPMP. Authorization to market Norvir is currently pending a final marketing approval by the European Commission in Brussels.

The scientific approval is in part based on the results of a study in patients with advanced HIV infection which showed a decrease in mortality, as well as illnesses frequently encountered in HIV-infected patients, in those receiving Norvir. Clinical studies have also demonstrated a decrease in the amount of the HIV virus measurable in the blood as well as an increase in CD4 cells, a type of white blood cell important in protecting against infections, in patients with both advanced and earlier stages of HIV infection who receive Norvir.

Protease inhibitors are a new class of drug with a mechanism of action that is different from previously available treatments for HIV infection and AIDS. Protease inhibitors such as Norvir block the action of HIV protease, an enzyme essential for the final development of the HIV virus. By interfering with the HIV protease enzyme, Norvir prevents the production of new, infectious viral particles.

"Based on the results of the clinical studies thus far, Norvir can have a significant positive impact on the health of people living with HIV infection," says Robert J. Schotzinger, M.D., Ph.D., of Abbott's international clinical research division. "Norvir will clearly be an important new tool for physicians in the treatment of patients with progressive HIV infection and AIDS."

Abbott Laboratories (NYSE: ABT) has a long-standing commitment to improving the health of patients with HIV infection and AIDS. In addition to Norvir, Abbott offers a comprehensive line of HIV screening and diagnostic tests; clarithromycin, an antibiotic which is effective in both the treatment and prevention of mycobacterium avium complex (MAC), an infection that is a major cause of illness and death in people with HIV infection; and nutritional products that meet the dietary needs caused by HIV infection and AIDS.

Abbott Laboratories is a global health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. Headquartered in the United States, the company employees 50,000 people and markets its products in more than 130 countries.

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