¿ Amrad Corp. Ltd., of Melbourne, Australia, entered a collaboration and license agreement with GlaxoSmithKline plc, of Brentford, UK. The multiyear deal focuses on two components of Amrad's suppressors of cytokine signaling (SCOS) platform technology, which Amrad said has potential for treatment of cancer and infectious diseases. Amrad will receive research and development funding from GlaxoSmithKline under the agreement for two years, and, contingent upon product discovery and commercialization, up to A$50 million (US$25.44 million) in milestone payments and royalties.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said it is making protocol changes to the Phase IIb trial of its lead complement inhibitor, TP10, after discussions with the FDA. Avant agreed to monitor patients for six months following treatment as well as the planned 60-day follow-up. The company said the changes will result in longer clinical trials, and now predicts completion of the Phase IIb trial in infants undergoing high-risk cardiac surgery in the first half of 2002.
¿ Boston Life Sciences Inc., of Boston, said that Atropine, a radio-imaging agent under development for diagnosis of attention deficit hyperactivity disorder, successfully identified adults with long-standing, expert-diagnosed ADHD in a Phase II study. The test identified statistically significant elevations in the number of brain dopamine transporters in diagnosed subjects compared to normal (p=0.001).
¿ Chiron Corp., of Emeryville, Calif., and Gen-Probe Inc., of San Diego, said the FDA accepted for review the biologics license application of the Chiron Procleix HIV-1/HCV assay for HIV-1 and hepatitis C virus. The nucleic acid amplification test is designed to detect the presence of HIV and HCV in whole blood and plasma in the earliest stages of infection, when the viruses appear in the blood but are undetectable though serological screening technologies.
¿ Diversys Ltd., of London, appointed Robert Connelly CEO. Connelly is the former CEO of Veritas Pharmaceuticals Inc.
¿ Genencor International Inc., of Rochester, N.Y., and DuPont Pharmaceuticals, of Wilmington, Del., signed an agreement expanding their multiyear research and development collaboration focused on metabolic pathway engineering. The companies said they will continue to develop bioprocessing technology for the manufacture of a critical monomer for synthesis of high-performance polyester from glucose. Genencor will receive research and development funding, potential milestone payments and royalties on product sales.
¿ Genentech Inc., of South San Francisco, and development partner Boehringer Ingelheim GmbH, of Ingelheim, Germany, said they will introduce Metalyse (tenecteplace, TNK-t-PA), a single-bolus thrombolytic agent, in Germany, the Netherlands, Sweden, Austria, Denmark and Finland within days. The European Commission granted marketing authorization for the heart attack therapeutic on Feb. 23, and it was launched in the U.S. after FDA approval in 2000 under the trade name TNKase.
¿ ImmuCell Corp., of Portland, Maine, entered a license and supply agreement with Novatreat Ltd., of Turku, Finland, covering certain nutritional and risk reduction rights for functional food applications of ImmuCell's DiffGAM technology outside North America. ImmuCell estimates fees totaling $100,000 this year in connection with the initial supply of clinical materials to Novatreat.
¿ Integrative Proteomics Inc., of Toronto, entered a strategic alliance with Bruker AXS Inc., Bruker Daltonics Inc., and Bruker Instruments Inc., all members of the worldwide Bruker BioSpin Group, of Billerica, Mass. The alliance of several technology development and collaboration agreements focuses on multidisciplinary proteomics technologies based on protein X-ray crystallography, biological NMR and mass spectrometry. IPI will obtain X-ray systems, high-field NMR and MALDI-TOF mass spectrometry systems as well as support from Bruker, and each of the Bruker companies agreed to make an undisclosed equity investment in IPI. In separate news, IPI appointed John Mendlein chairman and CEO. Mendlein is a former senior executive at Aurora Biosciences Corp., of San Diego.
¿ Karo Bio AB, of Stockholm, Sweden, and Bristol-Myers Squibb Co., of New York, extended their 1997 collaboration for a year for the second time, broadening the alliance centered on Karo's Molecular Braille technology. The expansion carries commitments for additional milestones for Karo. The companies expanded their original 1997 agreement, which resulted in two clinical development candidates for obesity treatment, in October 2000.
¿ Lorus Therapeutics Inc., of Toronto, said Dalton Chemical Laboratories Inc., also of Toronto, will manufacture Virulizin, Lorus' lead anticancer agent. Virulizin will enter a pivotal Phase III trial later this year, the company said, and the manufacturing agreement will both provide supply for the trial and also prepare for potential commercial sales. Virulizin is approved in Mexico for treating malignant melanoma.
¿ Mesothelioma Applied Research Foundation, of Santa Barbara, Calif., is providing two $100,000 grants for research to find a cure for mesothelioma. The foundation previously awarded two grants in November 2000.
¿ NexMed Inc., of Robbinsville, N.J., completed testing in a Phase II 140-patient efficacy and safety study of Alprox-TD, its treatment for severe erectile dysfunction. The randomized, seven-site, parallel, double-blind, placebo-controlled study was designed to evaluate the dose-response relationships of the safety and efficacy in three doses of Alprox-TD. The company expects to announce results in mid-April.
¿ OraSure Technologies Inc., of Bethlehem, Pa., said an article published in the March issue of Nature Biotechnology describes the use of its proprietary Up-Converting Phosphor Technology particles to detect DNA in microchips. The company said the particles have proven 1,000 times more effective than fluorescent technologies in this and other articles.
¿ Oxford BioMedica plc, of Oxford, UK, filed with UK regulatory authorities to move from the Alternative Investment Market to the London Stock Exchange through the placement of 172.3 million existing ordinary shares and an open offer to the public for the sale of 73.7 million new ordinary shares. Oxford expects the placement and the offer will raise #27 million (US$39.53 million) after expenses, and #10 million (US$14.64 million), respectively. The placement is being underwritten by N.M. Rothschild & Sons Ltd., and Beeson Gregory Ltd., and the open offer is self-managed.
¿ Sepracor Inc., of Marlborough, Mass., submitted a new drug application to the FDA for Soltara (norastemizole 30 mg capsules) for treatment of allergic rhinitis. The NDA contains data from seven large-scale studies, 30 smaller clinical trials and 200 preclinical studies. Sepracor also is developing a Soltara-pseudoephedrine combination product for treatment of allergic rhinitis as well as a syrup and a rapidly dissolving tablet.
¿ Targeted Genetics Corp., of Seattle, announced the formation of subsidiary CellExSys Inc.'s board of directors. Targeted Genetics CEO and President H. Stewart Parker will serve as chairman. Targeted Genetics spun off CellExSys in November. (See BioWorld Today, Nov. 9, 2000.)
¿ Trega Biosciences Inc., of San Diego, said stockholders approved its merger with LION Bioscience AG, of Heidelberg, Germany. The merger, announced in December, was valued at $35 million in LION American depositary shares. The companies expect the transaction to close this week. (See BioWorld Today Dec. 28, 2000.)
¿ Xanthon Inc., of Research Triangle Park, N.C., finalized a multiyear agreement with CMED/RELA, a division of Colorado MEDtech Inc., of Boulder, Colo., to manufacture production quantities of the Xanthon Xpression Analysis Instrument. Xanthon said it will begin receiving instruments this summer in anticipation of beta-site testing later this year and product launch in early 2002.