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| | | ![]() Norvir Granted Final Marketing Authorization in Europe For HIV Infection ABBOTT PARK, Ill., Aug. 27, 1996-- The European Commission, in Brussels, has granted final marketing authorization for Abbott Laboratories' protease inhibitor Norvir (ritonavir) for treatment of human immunodeficiency virus (HIV) infection and AIDS. In May, the Committee for Proprietary Medicinal Products (CPMP) delivered a positive scientific opinion on the granting of a European marketing authorization for Norvir for use in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adult patients with advanced or progressive immunodeficiency. Norvir was the first HIV protease inhibitor to receive scientific approval from the CPMP. "The data we have seen to date with Norvir offer new hope to AIDS patients," said Romeo T. Bachand, M.D., Ph.D., divisional vice president of medical and scientific affairs for Abbott's international division. "Norvir is an important new tool which will help change the way this disease is treated." Clinical trials of Norvir showed the drug to decrease the risk of disease progression and mortality in patients with HIV infection and AIDS. Clinical trials have also demonstrated that the drug has substantial antiviral activity, decreasing the amount of HIV virus measurable in the blood as well as increasing CD4 cells, a type of white blood cell important in protecting against infections, in patients with both advanced and earlier stages of HIV infection. Protease inhibitors are a new class of drug with a mechanism of action that is different from previously available antiretroviral treatments for HIV infection and AIDS. Protease inhibitors, such as Norvir, block the action of HIV protease, an enzyme involved in the final development of the virus. By blocking protease activity, protease inhibitors prevent production of infectious viral particles, therefore slowing HIV progression. Norvir is approved in the U.S., Canada, Switzerland, Brazil, Puerto Rico, Argentina, Colombia, Guatemala and Peru. Submissions in other countries around the world are pending. Additional submissions will be filed as individual country regulatory requirements are completed. Abbott has a long-standing scientific commitment to the creation of health care technologies that aid in the fight against HIV and related conditions. In addition to Norvir, Abbott offers a comprehensive line of HIV screening and diagnostic tests; clarithromycin, an anti-infective which has proven effective in both the prevention and treatment of MAC (mycobacterium avium complex), an infection that is a major cause of death in people with HIV; and Advera, a nutritional product formulated specifically to meet the unique dietary needs brought on by AIDS and HIV. Abbott committed more than $1 billion (U.S.) to research and development in 1995, with a significant portion dedicated to HIV/AIDS research. Abbott Laboratories is a global, diversified 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 employs 50,000 people and markets its products in more than 130 countries. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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