• 7TM Pharma A/S, of H rsholm, Denmark; TopoTarget A/S, of Copenhagen; and Danisco A/S, also of Copenhagen, formed a new consortium, called Biological Interaction Analysis, with the University of Southern Denmark at Odense and the Danish Technological Institute, Taastrup. The consortium has a budget of $6.8 million for three years and will develop advanced protein-analysis methods for application in drug development and food ingredients research. The consortium received $2.4 million from Denmark's Ministry of Science, Technology and Innovation.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., and Dr. Falk Pharma GmbH, of Freiburg, Germany, said TheraClec was granted orphan drug designation by the European Medicines Evaluation Agency. The compound was granted the designation for the treatment of malabsorption due to exocrine pancreatic insufficiency, a condition most often found in patients with cystic fibrosis, chronic pancreatitis, pancreatic cancer and other diseases related to the pancreas. TheraClec, which is in Phase II testing, received orphan drug status from the FDA in January 2002.

• Amarin Corp. plc, of London, closed the acquisition of Laxdale Ltd., of Stirling, Scotland, a private neuroscience development company. The acquisition provides Amarin with a neuroscience pipeline in clinical development for central nervous system disorders and neuroscience development capability. The most advanced candidate, Miraxion, for which Amarin originally licensed U.S. rights in November 2000, is in Phase III development for Huntington's disease.

• Arexis AB, of Gothenburg, Sweden, presented Friday the results of a Phase II trial on their human enzyme-replacement therapy for treatment of fat malabsorption in patients with cystic fibrosis. Arexis' study shows that cystic fibrosis patients with pancreatic insufficiency have a more rapid and efficient lipid uptake when supplemented with the enzyme BSSL (bil salt-stimulated lipase). The results were presented at the 18th annual North American Cystic Fibrosis Conference in St. Louis.

• Attana AB, of Stockholm, Sweden, raised €1.3 million in new investment from Carl Bennet AB and stersjöstiftelsen to fund expansion plans. The company has developed a chip-based biosensor for low-cost, online kinetic studies of molecular interactions. Its first commercial system, Attana 100, is in use in 10 companies and institutions in Sweden and the UK.

• Aureus Pharma, of Paris, completed a €3 million (US$3.7 million) private placement, which included two new investors: OTC asset Management and AXA Private Equity, as well as existing investors Bioam and CDC Enterprises-FP Gestion. The funds will be used to extend Aureus Pharma's product portfolio by developing new databases and software and to expand its marketing and sales capabilities globally.

• BankInvest Group, of Copenhagen, Denmark, raised a new $136 million fund for investing in biotechnology companies in the Nordic region. Some 70 percent of the total funding is earmarked for Danish companies. Two existing portfolio companies, Zealand Pharmaceuticals A/S, of Glostrup, Denmark, and HemeBiotech A/S, of Hiller d, Denmark, will receive $1.6 million each.

• Benitec Ltd., of Queensland, Australia, gained an exclusive license from Stanford University in Palo Alto, Calif., to use the Minicircle DNA technology developed at the school for all RNAi therapeutic uses, with sublicensing rights. Using the technology, researchers have demonstrated therapeutic levels of transgene product in animal models for up to 10 months, with no toxicity from the non-integrating vector. Financial terms were not disclosed.

• Biomax Informatics AG, of Martinsried, Germany, said a consortium of venture capital companies invested €2.25 million (US$2.8 million) in Biomax. Biomax develops customizable bioinformatics solutions.

• Crucell NV, of Leiden, the Netherlands, agreed to license its PER.C6 technology to Merial Ltd., of Duluth, Ga., for the development and commercialization of veterinary vaccines for foot-and-mouth disease. In return, Crucell will receive an up-front payment, milestone payments, annual maintenance fees and royalties on sales of vaccines. Further financial details were not disclosed.

• Dynavax Technologies Corp., of Berkeley, Calif., established a collaboration with the Riken Institute in Tokyo for the development of cedar tree allergy therapeutics using the company's immunostimulatory sequence (ISS)-based therapeutics platform. Terms of the two-year collaboration call for Dynavax to apply its know-how in the discovery and development of ISS-based allergy therapeutics and develop a cedar antigen-ISS conjugate product. The institute will further test such therapeutic candidates in animal models of cedar pollinosis. Financial terms were not disclosed.

• Eisai Co. Ltd., of Tokyo, signed a three-year use and propagation license for MultiCell hepatocytes with Nosan Corp., an exclusive sub-licensee in Japan of XenoTech LLC, the licensee for hepatocyte cell lines from MultiCell Technologies Inc., of Warwick, R.I. The contract allows Eisai to use Fa2N-4 hepatocytes for internal testing purposes at one site. Financial terms were not disclosed.

• Elan Corp. plc, of Dublin, Ireland, said it is not in merger or business combination negotiations or discussions with Biogen Idec Inc., of Cambridge, Mass. The company, which is focused on neurodegenerative diseases, autoimmune diseases and severe pain, made its statement in response to a specific Irish Stock Exchange query.

• ES Cell International Pte. Ltd., of Singapore, said the National Institutes of Health in Bethesda, Md., granted the company a resource infrastructure enhancement award for human embryonic stem cell (hESC) research. It provides funding support over the next three years and will be used to continue research activities into the growth, expansion and characterization of hESCs, as well as for testing, quality assurance and distribution of ESI's hESCs that are listed on the NIH Human Embryonic Stem Cell Registry.

• Genome Express, of Grenoble, France, launched a new service called Gextrack, a set of tools for analyzing, identifying and tracing foodstuffs and other fresh products through DNA analysis. The technology enables each component present in fresh or processed food to be identified and its origin traced. It also can detect potential allergens and genetically modified ingredients, as well as determine whether a foodstuff does not contain a particular ingredient.

• Global Life Science Ventures in Munich, Germany, added Holger Reithinger as a principal of the firm. He previously worked at 3i Group where he was the director of the company's health care practice in Germany.

• GNI Ltd., of Tokyo, entered two license agreements with the University of Cambridge in the UK. The agreements grant exclusive rights to intellectual property related to targets for Cambridge's angiogenesis and inflammation research, which includes new drug targets for a number of diseases.

• Inovio AS, of Oslo, Norway, received a second $1 million grant from the U.S. Army to continue its research on gene-based vaccines and therapeutics under the U.S. biodefense program. The funding will support further development of Inovio's Elgen gene delivery system, which relies on an electroporation method to introduce naked plasmid DNA to muscle cells. Inovio also entered a product development agreement with engineering consultants HotSwap AB, of Stockholm, Sweden, to develop a device incorporating the Elgen technology.

• Karo Bio AB, of Huddinge, Sweden, issued about 2.8 million shares at SEK8.50 apiece for gross proceeds of SEK24 million (US$3.3 million). The stock sale follows a rights issue that generated SEK96 million before costs. The company said it would use the funds to take internal projects into clinical trials. ABG Sundal Collier was Karo Bio's financial adviser.

• Kos Pharmaceuticals Inc., of Miami, reported that the company, through its marketing partner Merck KgaA, of Darmstadt, Germany, received marketing authorization for Niaspan (niacin extended-release tablets) in France. Niaspan, developed and manufactured by Kos, is indicated in France for the treatment of dyslipidemia, particularly in patients with combined mixed hyperlipidemia.

• The National Genotyping Center in Evry, France, discovered a new gene associated with ichthyosis, a genetic disease characterized by dry skin that can cause skin lesions in newborn babies, potentially leading to infections. They found that mutations in ichthyin, a hitherto unknown gene located on chromosome 5q33, play a role in a new form of autosomal recessive congenital ichthyosis. Four genes associated with the disease already have been identified, and all five appear to be involved in the same cellular mechanism that controls the hydration of the skin. Researchers said that more genes likely are to be discovered, since in some patients none of the five known genes are mutated.

• Newron SpA, of Milan, Italy, granted Dynogen Pharmaceuticals Inc., of Boston, exclusive worldwide rights to certain compounds in order to explore their potential for genitourinary and gastrointestinal disorders. Newron granted Dynogen a license to a number of ion channel modulators, including preclinical data packages and related intellectual property. Dynogen will apply its predictive pharmacology platform to identify those with the greatest potential for clinical efficacy. Financial terms were not disclosed.

• PowderMed Ltd., of Oxford, UK, began a Phase I trial of a therapeutic DNA vaccine for herpes simplex Type 2. The vaccine uses PowderMed's Particle Mediated Epidermal Delivery technology to deliver a DNA plasmid coding for four herpes simplex Type 2 antigens. The trial is being conducted in 36 otherwise healthy individuals with recurrent genital herpes caused by herpes simplex Type 2. In addition to assessing the vaccine's safety and tolerability, the study also will assess the patients' immune response.

• Prana Biotechnology Ltd., of Melbourne, Australia, released results of the open-label, 84-week extension of its Phase II trial of PBT-1 (clioquinol). All patients in the 36-week blinded and placebo-controlled portion of the trial continued PBT-1 treatment. Nine patients completed the study, which demonstrated that PBT-1 appears to slow the expected progression in Alzheimer's disease by about half, the company said. The data were published in the December 2003 issue of Archives of Neurology. Also, Prana said it plans to begin a Phase II/III study to examine the effect of PBT-1 in moderate to severe Alzheimer's disease patients in the late first quarter or the second quarter of next year. The study, to be called PLACQUE (Progression Limiting in Alzheimer's: Clioquinol's Efficacy), will include 435 patients in the UK, Australia and South Africa. Patients will be treated for 52 weeks after being randomized into placebo and two treatment arms (125 mg and 250 mg BID). The company expects results to be available no sooner than late 2006, but expects to provide updates as the trial progresses. In related news, Prana said findings published in the Sept. 30, 2004, edition of the Journal of Biological Chemistry support its theory that PBT-1 slows the progression of Alzheimer's disease.

• Renovis Inc., of South San Francisco, said that AstraZeneca plc, of London, would continue as planned with Phase III trials to determine the effect of Cerovive (NXY-059) on disability and neurological recovery in acute ischemic stroke patients. The decision is based upon a recommendation from an independent Data and Safety Monitoring Board and the trial's steering committee, and follows a recent interim analysis of the trials (SAINT I and II). Cerovive, a neuroprotectant with free-radical-trapping properties, is being developed by AstraZeneca under a license from Renovis.

• Serono SA, of Geneva, said the FDA approved Luveris (lutropin alfa for injection) for concomitant use with Gonal-f for the stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound LH deficiency. Women with HH are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support early pregnancy. Luveris is the first and only approved recombinant human form of luteinizing hormone, a naturally occurring fertility hormone.

• Tripep AB, of Huddinge, Sweden, shelved plans to seek a secondary listing on London's Alternative Investment Market, as it will net about SEK21.25 million (US$2.9 million) from a private placing, comprising the issue of 1.4 million new shares and 1.1 million treasury shares, priced at SEK8.50 per share. Company Chairman Rolf Nordström will guarantee the transaction. The company also said it will move its anti-HIV drug candidate, alpha-HGA, into a Phase I/II trial in Thailand early next year.