Tuesday May 5, 5:45 am Eastern Time
Company Press Release
SOURCE: Isis Pharmaceuticals, Inc.
Isis and CIBA Vision Announce European Regulatory Filing For CMV Retinitis Drug
ATLANTA and CARLSBAD, Calif., May 5 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG, announced today the filing of a Marketing Authorization Application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for its compound, fomivirsen, for the treatment of cytomegalovirus (CMV) retinitis. The application contains the same safety and efficacy information and indication included in the New Drug Application (NDA) for fomivirsen. The NDA was filed with the United States Food and Drug Administration (FDA) on April 8, 1998. This represents the first antisense compound to be filed for marketing rights in the United States and Europe.
Results from the Phase III trials of fomivirsen demonstrated that in both newly-diagnosed patients with CMV retinitis and in patients with advanced refractory disease, fomivirsen produced prolonged delay in disease progression.
''This filing reaffirms our confidence that fomivirsen will be a valued addition to the CMV patient population in Europe,'' said Daniel L. Kisner, M.D. President & Chief Operating Officer, Isis Pharmaceuticals. ''It also represents a successful effort by Isis and CIBA Vision to complete a filing with regulatory authorities in both the United States and Europe within weeks of each other.''
''Fomivirsen represents a new, potentially more effective treatment option for AIDS patients with CMV retinitis,'' said Luzi von Bidder, President, Ophthalmics Business Unit, CIBA Vision Worldwide. ''We are eager to add this novel antisense drug to our expanding ophthalmics product portfolio, and expect it will bring us a significant competitive advantage in the global retinal market.''
This press release contains forward-looking statements concerning the regulatory status and therapeutic and commercial potential of fomivirsen, an antisense drug in development. 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 and commercial potential of fomivirsen 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: fomivirsen, to treat CMV-induced retinitis in AIDS patients, has completed Phase III clinical trials and an NDA has been submitted to the FDA; 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/CGP64128A 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.
With worldwide headquarters in Atlanta, Georgia, USA, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. For more information, you are invited to visit the CIBA Vision website at www.cibavision.com.
CIBA Vision is a sector of Novartis AG, a world leader in Life Sciences with its core businesses in Healthcare, Agribusiness and Nutrition. In 1997, Novartis achieved Group sales of 31.2 billion Swiss francs and invested more than 3 billion Swiss francs in research and development. Headquartered in Basel, Switzerland, Novartis employs 87,000 people in more than 100 countries around the world.
SOURCE: Isis Pharmaceuticals, Inc.
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