o BioStratum Inc., of Research Triangle Park, N.C., presented preclinical results that showed that Pyridorin is effective in preventing the development of diabetes-induced kidney disease. Results will be presented at the Joslin Diabetes Center's 100th anniversary conference in Boston and at the 31st annual meeting of the American Society of Nephrology, in Philadelphia.
o Enzon Inc., of Piscataway, N.J., reached an agreement with the FDA for temporary labeling and distribution modifications for Oncaspar, an agent used in combination chemotherapy for patients with acute lymphoblastic leukemia who are hypersensitive to other treatments. During this temporary period, Enzon will distribute Oncaspar directly to patients on an as-needed basis. The action was prompted because some particulate matter was seen to have formed in some vials of Oncaspar. As a result, the company and the FDA agreed to use the drug only for intramuscular injection.
o Gensia Sicor Inc., of Irvine, Calif., and SangStat, of Menlo Park, Calif., received marketing clearance from the FDA for SangCya, its oral cyclosporine solution for the prevention of rejection of solid organ transplants.
o Glaxo Wellcome plc, of London, submitted a regulatory application for approval to market Agenerase, a new anti-HIV treatment, in Europe. Marketing applications were submitted for the U.S. and Canada on Oct. 16. Agenerase is a protease inhibitor that, in combination with two new nucleoside reverse transcriptase inhibitors, has produced significant improvements in patients with HIV infection. The drug was developed by Vertex Pharmaceuticals Inc., of Cambridge, Mass., and licensed to Glaxo Wellcome.
o Medeva plc, of London, was granted a license from the UK Medicines Control Agency to market Asmabec Clickhaler (beclomethasone dipropionate), a dry powder inhaler for the prevention of asthma attacks. The company also reported that a pan-European product license application was filed with the European Agency for the Evaluation of Medicinal Products for its hepatitis B vaccine product, Hepagene. A second application for Hepagene with the FDA should be filed by year's end.
o Neurobiological Technologies Inc., of Richmond, Calif., started a Phase IIb trial to evaluate Memantine as a treatment for painful peripheral diabetic neuropathy. The trial will evaluate the ability of Memantine to relieve chronic pain due to nerve damage, particularly as it interferes with sleep. Memantine is an orally available compound that appears to restore the function of impaired neurons by modulation activity of the NMDA receptor, which is integral to the membranes of such cells.
o Nova Factor Inc., of Memphis, Tenn., signed an agreement with Centocor Inc., of Malvern, Pa., for specialty distribution of Remicade (infliximab), a treatment for Crohn's disease. Remicade, formerly known as Avakine, was approved by the FDA in August for those with moderately to severely active Crohn's disease. (See BioWorld Today, Aug. 25, 1998, p. 1.)
o Pangea Systems Inc., of Oakland, Calif., reported that Monsanto Co., of St. Louis, has licensed its state-of-the-art sequence clustering and alignment tools. These computational tools allow more rapid and accurate clustering and alignment of Expressed Sequence Tags (ESTs) and full-length genetic sequences, as well as the ability to integrate data from public, third-party and internally generated plant and plant pathogen genomics databases.
o Pentose Pharmaceuticals Inc., of Philadelphia, reported that its Inactine technology destroys both enveloped and nonenveloped viruses in red blood cell-concentrated and plasma-derived therapeutic proteins without affecting their integrity. Inactine compounds are small molecule, electrophilic compounds that selectively bind and irreversibly modify nucleic acids, thereby preventing viral replication. The data were presented at the 51st annual meeting of the American Association of Blood Banks.
o Ribi ImmunoChem Research Inc., of Hamilton, Mont., withdrew its marketing authorization application for the use of Melacine melanoma vaccine for the treatment of Stage IV melanoma in Europe. The decision was made after discussions with the European Agency for the Evaluation of Medicinal Products, which requested that an additional Phase III study be done before reviewing the application. Ribi will continue to develop its FDA filing for the product. If approved, Melacine could be the first tumor-specific vaccine to reach market.