To: Mailbu who wrote (2281 ) 9/16/1998 9:42:00 AM From: Mailbu Read Replies (1) | Respond to of 4676
Wednesday September 16, 5:45 am Eastern Time Company Press Release SOURCE: Isis Pharmaceuticals, Inc. Isis Achieves $7.5 Million Milestone for FDA Approval of Antisense CMV Retinitis Drug European Regulatory Application Undergoing Review CARLSBAD, Calif., Sept. 16 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) announced that the recent approval by the U.S. Food and Drug Administration of Vitravene(TM)(fomivirsen sodium injectable) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS, triggers a $7.5 million milestone from Isis' distribution partner, CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG. Vitravene(TM) is the first in a class of novel therapeutics based on antisense technology to be approved for marketing in the U.S. Vitravene(TM) is indicated for the local treatment of CMV retinitis in patients with AIDS who are intolerant of or have a contraindication to other treatments for CMV retinitis or who were insufficiently responsive to previous treatments for CMV retinitis. The New Drug Application for Vitravene(TM) was filed on April 9, 1998. The FDA completed its review of the application and approved Vitravene(TM) for marketing on August 26, 1998. The NDA for Vitravene(TM) was reviewed under the agency's priority review process. The priority review process is reserved for therapies that may substantially improve the standard of treatment for a certain disease or condition. In July 1997, Isis established a worldwide distribution agreement with CIBA Vision for Vitravene(TM). A Marketing Authorization Application (MAA) submitted in May is currently under review with the European Agency for the Evaluation of Medicinal Products (EMEA) for the marketing of Vitravene(TM) in Europe. 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 is currently undergoing regulatory review in Europe; 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, rheumatoid arthritis and ulcerative colitis, and is being explored as 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 is in Phase I 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 medicinal chemistry and biology research programs support efforts in both antisense and small molecule drug discovery. This press release contains forward-looking statements concerning the therapeutic and commercial potential of Vitravene(TM), an antisense drug for the treatment of CMV retinitis. 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 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. Vitravene(TM) is a trademark of Novartis AG. SOURCE: Isis Pharmaceuticals, Inc. More Quotes and News: ISIS Pharmaceuticals Inc (Nasdaq:ISIP - news) Related News Categories: biotech, government, medical/pharmaceutical