To: scaram(o)uche who wrote (3492 ) 11/6/2002 2:18:04 AM From: scaram(o)uche Read Replies (1) | Respond to of 10345 Isis Pharmaceuticals and Elan Corporation Conclude Collaboration In HepaSense Joint Venture and Restructure OraSense Collaboration Wednesday November 6, 1:54 am ET Isis Regains Rights to ISIS 14803 for HCV CARLSBAD, Calif., Nov. 6 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS - News) announced today that it has regained rights to ISIS 14803, in connection with the termination of its collaboration with Elan Corporation, plc. (NYSE: ELN - News) related to the HepaSense(TM) Ltd. joint venture. Additionally, Isis and Elan have agreed to amend the terms and extend their collaboration in the Orasense(TM) Ltd., joint venture through the end of 2002. ADVERTISEMENT "We are pleased to have negotiated favorable outcomes to both of the joint ventures with Elan. Our partnerships with Elan have been highly productive, as we have leveraged the technology contributions and resources from both companies," said B. Lynne Parshall, Isis' Executive Vice President and CFO. "We are enthusiastic about the potential of ISIS 14803 for patients with hepatitis C virus, and very happy to regain complete ownership of this drug. We will continue to aggressively pursue the clinical development of ISIS 14803. Our agreement to continue the Orasense joint venture is a validation of our exciting work to develop oral formulations of antisense drugs, with ISIS 104838 leading the way." HepaSense HepaSense is focused on the clinical development of the antisense drug ISIS 14803 for patients with Hepatitis C. The conclusion of Elan's participation in the collaboration results from Elan's continuing restructuring efforts. As part of the termination, all rights to ISIS 14803 have been returned to Isis, with a potential royalty due to HepaSense. ISIS 14803 is an antisense inhibitor of the hepatitis C virus (HVC). Earlier this week, data presented from two Phase II studies demonstrated that ISIS 14803 is active in drug resistant, genotype 1 HCV patients, the most difficult-to-treat patient population. In the first trial, in which patients were dosed for one month, ISIS 14803 resulted in significant viral titer reductions. In a second ongoing trial, in which patients were dosed for three months, even more profound viral titer reductions were observed in six of 17 patients. The safety and efficacy of ISIS 14803 are being further evaluated in this ongoing 40 patient Phase II trial. Data from each of these trials were presented in November at the 53rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) Monday. Orasense Orasense is a joint venture to develop an oral delivery platform for antisense drugs, and to develop an oral formulation of ISIS 104838, an antisense inhibitor of TNF-alpha, for the treatment of rheumatoid arthritis. The collaboration will continue through the remainder of this year, with Isis and Elan contributing funding according to their ownership, 80.1 percent and 19.9 percent, respectively. In 2003, Elan will have the option to extend or conclude its participation in the Orasense collaboration. In Orasense, multiple oral solid formulations of a second-generation antisense drug are being evaluated in Phase I clinical trials. Data from these trials will be presented at the 2002 annual meeting of the American Association of Pharmaceutical Scientists (AAPS) in November. "Through our Orasense collaboration we have shown it is feasible to achieve oral systemic delivery of antisense oligonucleotides," stated Seamus Mulligan, Elan's Executive Vice President for Corporate Business Development. "This represents a major breakthrough in oral delivery of macromolecules. In addition, the agreements with Isis are important steps in Elan's restructuring efforts." Isis will conduct a live webcast conference call to discuss this release and the Company's third quarter financial results today, Wednesday, November 6 at 8:30 a.m. Eastern time. To participate over the Internet go to www.isispharm.com or to firstcallevents.com . A replay of the webcast will be available at this address for up to 30 days. (snip)