Active Biotech AB, of Lund, Sweden, said it selected a candidate systemic lupus erythematosus (SLE) treatment, ABR-215757, for clinical development. No new product has been registered for treatment of SLE, an autoimmune disease that primarily affects women of fertile age, for over 40 years, the company said. ABR-215757 demonstrated promising activity in preclinical models of autoimmune disease and showed a favorable toxicological profile. The company said it plans to commence clinical trials next year.
Alizyme plc, of Cambridge, UK, was granted regulatory permission for a Phase IIb trial of the lipase inhibitor ATL-962 in the treatment of obesity. It follows positive Phase Ib trials that provided proof of concept, allowing Alizyme to avoid conducting a Phase IIa trial. The Phase IIb will be a randomized, double-blind trial comparing three doses of ATL-962 to placebo. The trial will enroll up to 340 clinically obese patients, who, apart from weight loss, will be monitored for other parameters associated with obesity, including markers for diabetes and high cholesterol. The results are expected in the third quarter of 2003.
Amedis Pharmaceuticals Ltd., of Cambridge, UK, agreed to a collaboration with drug discovery services company Argenta Discovery Ltd., of Harlow, UK, under which Argenta will provide small-molecule inhibitors for members of the metallo and aspartyl protease enzyme families. The work will involve optimizing a number of Amedis' patent estate of protease inhibitors, which the company has generated with its proprietary chemistry technology.
BioVex Ltd., of Oxford, UK, said it received permission for a Phase I trial of OncoVEX GM-CSF, a cancer vaccine. The safety and biological activity of the vaccine will be evaluated in melanoma, breast cancer, gastrointestinal cancer and head and neck cancer in an 18-patient study. OncoVEX GM-CSF is a herpes simplex virus engineered to replicate in and destroy cancer cells, and carrying the gene encoding the immune stimulator granulocyte macrophage-colony stimulating factor.
Charles River Laboratories International Inc., of Wilmington, Mass., said it paid €25 million in cash to acquire drug discovery and development services company Biological Laboratories Europe Ltd., of Ballina, Co. Mayo, Ireland. BioLabs achieved a compound revenue growth rate of 25 percent over the past three years, providing scientific support services to the growing base of multinational pharmaceutical and medical device manufacturers located in Ireland. Its range of services includes the development and conduct of bioassays for testing the safety of toxins, hormones and other biologics used in medical treatments. It posted turnover of €10 million for the fiscal year ended Jan. 31.
Devgen NV, of Ghent, Belgium, said it appointed Vincenzo Facchini as head of R&D in a move to strengthen its capabilities in small-molecule drug discovery and development. Facchini has more than 20 years of international pharmaceutical research experience. His most recent post was senior director of drug metabolism and pharmacokinetics at Aventis SA, of Strasbourg, France, where he supported the company's projects in central nervous system disorders, anti-infectives and oncology. Devgen is a functional genomics and drug discovery company .
GeneScan Analytics GmbH, of Freiburg, Germany, signed a global cooperation agreement with Bureau Veritas Quality International GmbH to support agricultural and food companies in setting up and certifying control systems to keep products from genetically modified organisms separate from conventionally produced products. The deal anticipates the introduction of labeling requirements in the European Union as early as 2003 for products made from genetically modified organisms. Tightened import regulations on those products also are likely. Financial details of the marketing program were not disclosed. GeneScan specializes in devising processes that distinguish between genetically modified and conventionally produced organisms.
Protherics plc, of Macclesfield, UK, said it filed for UK patents for a series of antigens against vascular endothelial growth factor for use in a vaccine to prevent cancer metastases by inhibiting angiogenesis. Several formulations of the VEGF vaccine have been tested in a preclinical model of melanoma tumor spread and have shown extensive inhibition of tumor cell colony formation, along with high antibody levels. The company said it expects to start clinical trials in the fourth quarter of 2003.
Vernalis Group plc, of Winnersh, UK, said it received a milestone payment of more than $5 million last week, when its lead product, Frova, for the treatment of migraine, was launched on the U.S. market. The payment came from Elan Corp. plc, of Dublin, Ireland, which is marketing Frova jointly with UCB Pharma Inc. Robert Mansfield, Vernalis' CEO, said, "We can now anticipate the commencement of a continuing revenue stream from royalties on Frova sales."