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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: kendall harmon who wrote (2645)	9/2/1999 8:46:00 AM
From: Webhead	Read Replies (1) \| Respond to of 4676

news, Ed ========= September 02, 1999 08:35 Isis Reacquires Full Rights to Isis 2302; Isis Plans NDA Filing in Early 2000 Pending Review of Data Jump to first matched term CARLSBAD, Calif., Sept. 2 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP) announced today that it has reacquired ISIS 2302, a compound that was codeveloped during a five-year collaboration in cell adhesion between Isis and Boehringer Ingelheim (BI). This reacquisition was mutually agreed upon by Isis and BI and will enable Isis to establish a new marketing partner with a strong presence in the gastrointestinal (GI) market. Based on an interim analysis of the data from an ongoing pivotal trial of ISIS 2302 in Crohn's disease, Isis is preparing a New Drug Application (NDA), the final step in securing approval for the marketing of a pharmaceutical product. If the final data from this trial, scheduled to complete this year, are positive Isis anticipates filing the NDA, in the first quarter of 2000. "We are extremely pleased to have reacquired ISIS 2302, as it is our most important near-term asset," said Stanley T. Crooke, M.D., Ph.D. "We can now choose a new partner to market this high value, novel drug for Crohn's disease. We believe that our financial return on this drug will be directly related to our ability to partner with a company that can optimize its commercial potential in the gastrointestinal market. Our ability to choose a new marketing partner with a strong GI focus will increase the overall value of the launch while lowering the associated costs. And we believe that the short and long term financial impact to Isis of such a relationship will be positive." Crohn's disease is a GI disease affecting more than 800,000 patients worldwide. ISIS 2302 is an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), a molecule involved in a wide range of inflammatory and autoimmune diseases. A Phase II study of ISIS 2302 in Crohn's disease demonstrated that the drug allowed patients to decrease their steroid usage in a statistically significant manner with many drug treated patients experiencing rapid and long-term disease remissions. A Phase II trial of ISIS 2302 to prevent kidney transplant rejection is near completion. In addition, Isis is continuing to expand the therapeutic potential of ISIS 2302 by initiating clinical studies over the next 9 months for a topical formulation of ISIS 2302 for psoriasis and an enema formulation of ISIS 2302 for ulcerative colitis. "This is an extremely important step for Isis," said Debby Jo Blank, M.D., Executive Vice President at Isis. "Based on the high level of interest pharmaceutical companies have shown in ISIS 2302 and the active negotiations currently in progress with several such companies, Isis is in a strong position and expects to be able to finalize a relationship with a new marketing partner shortly." Under the terms of the renegotiated agreement with BI, Isis will be solely responsible for the development and commercialization of ISIS 2302 and other antisense inhibitors of cell adhesion molecules discovered during the collaboration. BI will receive a royalty on the commercial sales of these antisense drugs. BI will become solely responsible for the development and commercialization of any small molecule inhibitors of cell adhesion molecules discovered during the collaboration with Isis receiving a royalty on the commercial sales of these small molecule drugs. The Isis-BI collaboration began in 1995. The collaboration supported the clinical development of ISIS 2302 in a number of different diseases, and the discovery of both small molecule and antisense inhibitors to various novel cell adhesion targets. Isis will continue to receive funding from BI for the research part of the collaboration for the remainder of 1999. The research collaboration will continue to allow the parties to exploit the importance of and the untapped potential for drug discovery in this area. This press release contains forward-looking statements pertaining to the collaboration in cellular adhesion between Isis and Boehringer Ingelheim. 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 partnerships and collaborations are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1998 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 approval 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 programs support efforts in both antisense and small molecule drug discovery. Vitravene(TM) is a trademark of Novartis AG. SOURCE Isis Pharmaceuticals /CONTACT: Christopher Keenan, Corporate Communications of Isis Pharmaceuticals, 760-603-2641/ /Web site: isip.com