To: Webhead who wrote (2646 ) 9/2/1999 9:10:00 AM From: Webhead Read Replies (1) | Respond to of 4676
More of same but nice positive spin, Ed ------ Isis in Late Stage Negotiations to Commercialize Isis 2302 Jump to first matched term CARLSBAD, Calif., Sept. 2 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP) announced today that it is in late stage negotiations with several major pharmaceutical companies to commercialize ISIS 2302 which is completing a pivotal quality trial for Crohn's disease. This potential transaction will provide Isis a marketing partner expert in the gastrointestinal (GI) market. The proposed relationships will thus optimize the commercial potential of ISIS 2302. The transactions being considered will substantially enhance Isis' short and long-term financial position. Isis believes it will complete a transaction in the near term. "Our primary objective is to find the best marketing partner for ISIS 2302. We are extremely pleased at the level of interest shown in ISIS 2302 by several major pharmaceutical companies," said Stanley T. Crooke, M.D., Ph.D. Chairman and CEO of Isis. "We are confident that ISIS 2302 will be marketed by an experienced and dedicated sales force with long standing relationships with GI specialists, thus enhancing the commercial potential of the drug." ISIS 2302 is an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), a molecule that plays a role in a wide range of inflammatory diseases, including Crohn's which affects more than 800,000 patients worldwide. Enrollment in a 300 patient pivotal trial for ISIS 2302 in Crohn's disease was recently completed, with final results of the trial expected by the end of the year. Based on an interim analysis of the pivotal trial data, Isis has begun preparation of a new drug application (NDA). Should the data from the pivotal trial be positive, Isis will file an NDA early in 2000. Results from an earlier Phase II study demonstrated that ISIS 2302 was well tolerated. In addition, patients treated with ISIS 2302 experienced prolonged disease remission and many were able to discontinue or reduce their steroid usage. Isis announced today that it has reacquired from Boehringer Ingelheim (BI) ISIS 2302, the most advanced compound coming from a research collaboration between the two companies. Additional details regarding the ISIS -- BI collaboration are contained in a separate company release issued today. This press release contains forward-looking statements pertaining to the commercialization of ISIS 2302. 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 corporate 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