Scott and all:
Wednesday July 22, 5:58 pm Eastern Time
Company Press Release
SOURCE: Isis Pharmaceuticals, Inc.
Isis and CIBA Vision's Drug For CMV Retinitis Receives Advisory Committee Recommendation For Approval
CARLSBAD, Calif., and ATLANTA, July 22 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG, announced that the Food and Drug Administration's (FDA) Ophthalmic Drugs Subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee has voted to recommend approval of Vitravene(TM) (fomivirsen) for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients.
Vitravene 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 is the first antisense drug to be filed for commercial marketing review. The New Drug Application (NDA) for Vitravene was filed by Isis on April 9, 1998, and is being reviewed under the agency's priority review process.
''We are very gratified by the Advisory Committee's recommendation for approval of Vitravene,'' said Stanley Crooke, M.D., Ph.D., Chairman and Chief Executive Officer, Isis Pharmaceuticals. ''This is an exciting milestone in the development of antisense technology and in Isis' history. Vitravene is the first antisense drug to have been recommended for approval by an FDA Advisory Committee. We are optimistic that many other antisense drugs will follow in its footsteps. We believe that Vitravene has the potential to become the cornerstone therapy for CMV retinitis, and that patients and physicians will welcome this important new therapeutic alternative. We look forward to working with our partner, CIBA Vision, to bring Vitravene to patients with CMV retinitis as expeditiously as possible.''
''The rising failure rate of protease inhibitor-based combination AIDS therapy due to resistance, toxicity and non-compliance signals a potential resurgence in CMV retinitis and other opportunistic infections,'' said Daniel L. Kisner, M.D., President and Chief Operating Officer, Isis. ''We are optimistic that Vitravene will meet the growing need for a safe, effective and well-tolerated treatment for people living with AIDS and CMV retinitis.''
''We are very pleased with the Advisory Committee's recommendation for approval,'' said Luzi von Bidder, President of CIBA Vision's Ophthalmics Business Unit. ''We look forward to our continued efforts with Isis to bring this new treatment to AIDS patients as quickly as possible.''
''I believe that Vitravene will offer several important benefits to patients with CMV retinitis, including convenient local delivery and lack of systemic side effects,'' said Debra A. Goldstein, M.D., Assistant Professor of Ophthalmology of the University of Illinois at Chicago. ''Because Vitravene is designed to work through a novel antisense mechanism of action, the potential for resistance is considerably reduced, making it an ideal therapy in patients resistant to other agents.''
The committee, composed of seven voting members, reviewed safety and efficacy data from the Phase III trials of Vitravene. Results from trials in both newly-diagnosed patients and patients with advanced disease showed that Vitravene produced prolonged delay in progression of CMV retinitis, with similar median times to progression.
Vitravene, administered locally into the eye by intravitreal injection, was shown to be well-tolerated. The most frequently observed ocular side effects were transient increased intraocular pressure and generally mild to moderate, reversible intraocular inflammation. The retinal detachment rate overall in the Phase III program was considerably lower than the incidence of retinal detachment commonly observed in patients with CMV retinitis. There was no evidence of any systemic toxicity from Vitravene.
In July 1997, Isis and CIBA Vision established an exclusive worldwide distribution agreement. If Vitravene is approved by the FDA, Isis and CIBA Vision are prepared to launch the drug upon approval. A Marketing Authorization Application (MAA) for Vitravene was filed with the European Agency for the Evaluation of Medicinal Products (EMEA) in May 1998 and is currently undergoing review.
This press release contains forward-looking statements concerning the therapeutic potential of Vitravene, 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 are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1997 and in the company's most recent quarterly report on Form 10-Q, which are 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, to treat CMV-induced retinitis in AIDS patients, has completed Phase III clinical trials and an NDA has been filed and has been recommended for approval by an FDA advisory committee; 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/CGP 64128A is in Phase II trials as a treatment for cancer; ISIS 5132/CGP69846A 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 combinatorial drug discovery.
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