To: John McCarthy who wrote (471 ) 6/12/1999 11:41:00 PM From: gao seng Read Replies (1) | Respond to of 550
Wild guess here - check out ISIP Isis and CIBA Vision Announce European CPMP Recommends Approval of Vitravene for Patients with Both Newly Diagnosed and Advanced CMV Retinitis CARLSBAD, Calif., April 28 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG, have been informed that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) have issued a positive opinion to approve the Marketing Authorization Application (MAA) of Vitravene(TM) (fomivirsen) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The MAA was filed by CIBA Vision in April, 1998. The Committee recommended that until further experience is gained, Vitravene(TM) be approved for use in the local treatment of CMV retinitis in newly diagnosed or advanced CMV retinitis when other therapies are considered unsuitable or have been ineffective. Vitravene(TM) is an antisense inhibitor of CMV replication, the virus that causes retinitis. CMV retinitis is a degenerative opportunistic infection that affects people with AIDS and results in blindness. Vitravene(TM) is the first antisense drug to be filed for commercial marketing review. Vitravene(TM) received approval for marketing in the United States in August, 1998. ''We are pleased that the committee recognizes the benefits of Vitravene(TM) in providing patients with an additional treatment option for CMV retinitis and especially pleased that the committee recommended Vitravene(TM) for both newly diagnosed and advanced patients,'' said Stanley T. Crooke, Chairman and CEO of Isis Pharmaceuticals. ''Assuming that the European Commission follows the CPMP recommendation, it will provide European patients and physicians with a new therapy with proven effectiveness against this disease.'' CIBA Vision holds exclusive worldwide distribution rights to Vitravene(TM). This press release contains forward-looking statements pertaining to the therapeutic potential of Vitravene(TM), an antisense drug in development as a treatment for CMV retinitis in AIDS patients. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. These and other risks concerning the therapeutic potential of Vitravene(TM) are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1997 which is on file with the U.S. Securities Exchange Commission, copies of which are available from the company. Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has six compounds in human clinical trials: Vitravene(TM) (fomivirsen), to treat CMV-induced retinitis in AIDS patients, has been approved for marketing by the FDA and has recently received a positive recommendation by the EMEA for European marketing; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's disease, Phase II clinical trials for renal transplant rejection and is being explored as an enema formulation for ulcerative colitis, a topical administration for psoriasis and an aerosol administration for asthma; ISIS 3521 is in Phase II trials as a treatment for cancer; ISIS 5132 is in Phase II clinical trials as a treatment for cancer: ISIS 2503 has entered Phase II trials as a treatment for cancer and ISIS 13312 is in Phase I/II clinical trials for the treatment of CMV retinitis in AIDS patients. The company also has several additional compounds in preclinical development. ISIS' broad medical chemistry and biology research