To: Bill Tomko who wrote (64 ) 3/16/1998 11:49:00 AM From: Mark Duper Read Replies (1) | Respond to of 92
Schering-Plough and Ribi ImmunoChem Announce Distribution Agreement For MELACINE(R) Melanoma Vaccine March 16, 1998 8:28 AM EST MADISON, N.J., and HAMILTON, Mont., March 16 /PRNewswire/ -- Schering- Plough Corporation (NYSE: SGP) and Ribi ImmunoChem Research, Inc. (Nasdaq: RIBI) today announced an agreement giving Schering-Plough exclusive worldwide rights, except for Canada, to distribute, market and sell Ribi's MELACINE(R), a novel therapeutic vaccine in development for the treatment of melanoma. Under terms of the agreement, Ribi could receive up to $30 million from Schering-Plough in signing fees and milestone payments. Milestone payments will be paid to Ribi upon gaining U.S. and European marketing clearances for MELACINE as therapy for Stage IV melanoma (metastatic, disseminated disease). Additional milestone payments will be paid upon gaining U.S. and European marketing clearances for MELACINE as either combination therapy with INTRON(R) A (interferon alfa-2b) for Stage IV melanoma or as monotherapy for Stage II melanoma to prevent recurrence of disease following surgical removal of primary tumors. Ribi will also receive transfer payments for supplies of MELACINE and margins on Schering-Plough sales of MELACINE. "Schering-Plough is the consummate partner for the distribution of MELACINE because of its expertise in marketing biotherapeutics to oncologists," said Robert E. Ivy, chief executive officer, president and chairman of Ribi ImmunoChem. "Schering-Plough has established a strong foundation to build on through its worldwide sales of INTRON A as adjuvant therapy for early-stage melanoma. This agreement is the linchpin in Ribi's effort to provide MELACINE to patients with Stage IV melanoma who desire a more patient-friendly therapy than is currently available," Ivy said. "We are pleased to join Ribi in this agreement, which should further strengthen Schering-Plough's position in oncology therapy," said Thomas C. Lauda, executive vice president, global marketing, Schering-Plough Pharmaceuticals. He noted that, when cleared for marketing, MELACINE would complement INTRON A in treating melanoma. Based on results of completed Phase III clinical studies, Ribi expects to submit a Marketing Authorization Application for MELACINE as monotherapy for Stage IV melanoma to the European Medicines Evaluation Agency in the first quarter of 1998 and a Biologics License Application to the U.S. Food and Drug Administration in the second half of 1998. A Phase III clinical study with MELACINE as adjuvant therapy is ongoing to determine its activity in preventing recurrence in Stage II melanoma patients who have had primary tumors surgically removed. Published data indicate that a significant percentage of these patients have persistent malignant melanoma cells, with a significant risk of developing recurrent disease within 18-24 months of surgery. MELACINE may enhance immune responsiveness among these early-stage, immunocompetent patients, with the potential to eradicate micrometastatic disease that escaped surgery. In addition, Phase III clinical testing is ongoing to determine the activity of MELACINE and INTRON A as combination therapy for Stage IV melanoma. 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. Schering-Plough Pharmaceuticals is the worldwide pharmaceutical research and marketing unit of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide. SOURCE Schering-Plough Corporation c PR Newswire. All rights reserved.