Spring cleaning by GENIZ

GENIZ and its SciGenics Inc. R&D spin-off discontinued testing of recombinant human M-CSF for infectious disease due to a lack of positive results in animal models. As a result, no additional AIDS patients with Mycobacterium avium intracellulare infections will be enrolled in an investigator-sponsored study. GENIZ said it has seen no definitive clinical responses in its M-CSF cancer trial, but will have sufficient data by the end of November to determine whether to continue development in the cancer indication. GENIZ plans at mid-year to begin a study of M-CSF in patients with severely high blood cholesterol levels.

On the patent front, Baxter International, GENIZ's worldwide licensee for recombinant Factor VIII, settled with Rhone-Poulenc Rorer and The Scripps Research Institute a 1987 patent dispute concerning plasma-derived and recombinant Factor VIII products to treat hemophilia A. Baxter will pay Rhone-Poulenc $105 million as well as royalties and processing fees based on sales. Rhone-Poulenc, the Scripps licensee, has signed a long-term agreement under which Baxter may supply Rhone-Poulenc with recombinant Factor VIII, giving GENIZ an opportunity to earn additional manufacturing revenue. However, GENIZ has also agreed to share in the cost of Baxter's royalty payments to Rhone-Poulenc by lowering the royalties it gets from Baxter. GENIZ spokesman Dennis Harp said the increased manufacturing revenues should more than offset the lower royalty payments. (Also last week, the European Community's Committee for Proprietary Medicinal Products recommended approval of Baxter's Recombinate Factor VIII.) ...