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Biotech / Medical : Ribi Immunochem (ribi) -- Ignore unavailable to you. Want to Upgrade?

To: needawin who wrote (78)	6/24/1998 1:59:00 PM
From: mike head	Read Replies (1) \| Respond to of 92

Here's some interesting news... Schering-Plough Acquires Marketing Rights to Ribi's Melacine in Canada HAMILTON, Mont. and EDMONTON, Alberta, June 24 /PRNewswire/ -- Ribi ImmunoChem Research, Inc. (Nasdaq: RIBI) announced today that Schering-Plough Corporation (NYSE: SGP) of Madison, New Jersey, has acquired exclusive rights in Canada to distribute, market and sell Melacine melanoma theraccine, Ribi's novel therapeutic melanoma vaccine currently under regulatory review. This amends the distribution agreement for Melacine announced in March of 1998 and gives Schering-Plough exclusive marketing rights to Melacine on a worldwide basis, once approved. Canadian marketing rights to Melacine were previously held by Biomira Inc. (Nasdaq: BIOMF) of Edmonton, Alberta. "We are very pleased to expand our agreement with Schering-Plough to include Canada," said Robert E. Ivy, CEO, President and Chairman of Ribi ImmunoChem Research, Inc. "Their knowledge of the worldwide oncology market and biotherapeutic experience selling Intron A (interferon alfa-2b, recombinant) as adjuvant therapy for early-stage melanoma makes Schering-Plough Ribi's ideal partner to market Melacine as a patient-friendly therapy for the treatment of melanoma." Alex McPherson, MD, PhD, Biomira's President and CEO, said "Relinquishing the Canadian marketing rights for Melacine is in line with our announced focus on our own vaccine product candidates. From a business perspective, it would not be prudent for Biomira to build the infrastructure necessary for Canadian marketing at this time. We have, however, been pleased to play a role in working with Ribi toward this pending Canadian approval and any financial obligations on Biomira's part have been recovered in this transfer agreement." Ribi filed a New Drug Submission (NDS) for Melacine in Canada in 1997 based on results of a completed Phase 3 clinical study in patients with Stage IV melanoma. An answer is expected in the near future. In addition to the Canadian NDS, a Marketing Authorization Application for Melacine as monotherapy for Stage IV (disseminated) melanoma was filed with the European Medicines Evaluation Agency in March of 1998, with a decision expected by the end of this year. Ribi also plans to file a Biologic License Application for Melacine with the U.S. Food and Drug Administration in the second half of 1998. If approved, Melacine potentially would be the first tumor-specific therapeutic cancer vaccine to be commercialized. When all patient data included in the completed Phase 3 trial were analyzed, no statistically significant difference in median survival was found between the Melacine arm and the commonly used four-drug chemotherapy arm. However, when data on only those patients who experienced complete and partial objective clinical responses were analyzed, there was a trend favoring Melacine, with a median survival of 34 months compared to 15 months for patients treated with chemotherapy. Further, patients receiving Melacine enjoyed superior quality of life during therapy as compared to the four-drug chemotherapy control arm. Melacine is also being studied in two additional Phase 3 trials. The Southwest Oncology Group is conducting a trial of Melacine in patients with Stage II melanoma, as adjuvant therapy after surgical removal of primary disease. In cooperation with Schering-Plough, Ribi is conducting a trial using combination therapy of Melacine and Intron A in Stage IV melanoma. Results from these two trials are expected in 1999. "Ribi is very enthusiastic regarding the potential approval of Melacine from the Canadian, European and U.S. regulatory agencies, and the support of Schering-Plough as our marketing partner. We are working together closely to take advantage of their expertise in the regulatory review process and to coordinate Ribi's plans for producing commercial quantities of Melacine," explained Mr. Ivy. "If approved for use in all stages of melanoma, worldwide sales of Melacine could approach between $300-400 million annually." Ribi ImmunoChem Research, Inc., a biopharmaceutical company founded in 1981, is engaged in the development of immunomodulators for use in preventing and treating human disease. Forward Looking Information Statements in this news release are based on current expectations. Actual results may differ materially based upon various risk factors. Additional information regarding risk factors is contained in the Company's Form 10-K for the year ended 1997, as filed with the U.S. Securities and Exchange Commission. /CONTACT: Robert E. Ivy, Chief Executive Officer, President and Chairman, or Kris Dyszynski, Director, Licensing Activities of Ribi ImmunoChem Research, Inc., 406-363-6214/