European Committee for Proprietary Medicinal Products Adopts Positive Opinion For Reformulated Norvir(R) (Ritonavir)

Abbott Park, Ill. (PROTEXT) - Abbott Laboratories (NYSE: ABT) today announced that the European Union's Committee for Proprietary Medicinal Products (CPMP) has adopted a positive opinion on Norvir(R) (ritonavir) soft capsules. Norvir is a protease inhibitor indicated in combination with other anti- retroviral medications for the treatment of HIV infection. The CPMP opinion will be considered by the European Commission, which will make a final decision regarding the issue of the marketing authorization, a process that takes approximately 90 days. The positive opinion on Norvir soft capsules follows intense reformulation work at Abbott after an announcement in July 1998 that a new crystalline structure of ritonavir, which affected how the hard capsule dissolved, would interrupt the production of Norvir hard capsules. An application for the reformulated Norvir soft capsules was submitted this past January to the European Agency for the Evaluation of Medicinal Products (EMEA). "The positive opinion is a major step forward in bringing Norvir capsules back to patients in Europe," said David Goffredo, vice president, European operations, Abbott Laboratories. "We appreciate the efforts that European and other regulatory agencies worldwide have made in working closely with us on this formulation throughout the past year." Norvir is a highly potent inhibitor of HIV protease and has been shown to improve survival in patients with HIV when combined with other anti-retroviral agents. More recently, Norvir has been shown to reduce viral load below the limit of detection when used in combination with other protease inhibitors and administered twice daily. The soft capsules have undergone a number of tests to ensure stability. Norvir oral solution has allowed patients to continue therapy during the period of time when hard capsules were not available. Norvir soft capsules are approved in several countries, including Switzerland and the United States. Norvir is not a cure for HIV infection. People treated with Norvir may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Norvir may not be right for everyone, including people with liver disease, hepatitis or hemophilia. Common adverse reactions include fatigue, vomiting, diarrhea, loss of appetite, abdominal pain, taste disturbance, tingling sensation or numbness in the hands, feet, or around the lips, headache and dizziness. Abbott Laboratories has been a leader in AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV in the blood. Since then Abbott has developed the HIV protease inhibitor Norvir, and developed Advera, a nutritional supplement to meet the unique dietary needs of people living with HIV. Abbott continues to conduct aggressive research on new treatments to fight HIV and AIDS. 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 56,000 people and markets its products in more than 130 countries. ots Original Text Service: Abbott Laboratories Internet: http://www.newsaktuell.de Contact: Laureen Cassidy of Abbott Laboratories (USA) 847-938-7743 Company News On-Call: http://www.prnewswire.com/comp/110328.html or Fax, (USA) 800-758-5804, ext. 110328 Web site: http://www.abbott.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT