• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted Ebersberg, Germany-based MWG Biotech AG a nonexclusive license to provide research products and services in RNA interference under the Kreutzer-Limmer patent family owned by Alnylam that covers short interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells. Financial terms were not disclosed.

• Ark Therapeutics Group plc, of London, completed patient enrollment in the low-dose arm of the Phase II study of Trinam in preventing intimal hyperplasia after vascular graft access surgery in patients with kidney failure, and has received approval to move to the higher dose. Trinam uses an adenoviral vector to deliver the gene for vascular endothelial growth factor. The Phase I studies showed successful gene transfer and a significant effect in preventing intimal hyperplasia.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and RiNA GmbH, of Berlin, Germany, started a deal to develop methodologies to knock down human disease-related genes in the rat via RNA interference. Three laboratories at Artemis, the Max-Delbruck-Center for Molecular Medicine and the Institute for Virology and Immunobiology of the University of Wurzburg in Germany will participate. Artemis will receive a €1.3 million (US$1.6 million) research grant from the German government, and holds commercialization rights to products.

• Bavarian Nordic A/S, of Copenhagen, Denmark, initiated a Phase II trial to investigate the safety and immunogenicity of the smallpox vaccine Imvamune in HIV-infected patients. It involves 150 volunteers who will be treated at five U.S. sites. It is the company's second clinical study of Imvamune in HIV patients.

• BioAlliance Pharma SA, of Paris, submitted an investigational new drug application to conduct a pivotal Phase III trial of its antifungal agent, miconazole Lauriad, a once-daily 50-mg extended-release bioadhesive buccal tablet in development as a first-line local treatment for oropharyngeal candidiasis. Pending clearance by the FDA, the company plans to begin the trial in HIV patients during the fourth quarter.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the Phase III Tysabri (natalizumab) add-on trial with Avonex (interferon beta-1a) met the two-year primary endpoint of slowing the progression and disability in patients with relapsing forms of multiple sclerosis. The addition of Tysabri to Avonex resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by Avonex alone, and data also demonstrated that Tysabri plus Avonex led to a 56 percent relative reduction in the rate of clinical relapses compared to Avonex alone. Biogen Idec and Elan voluntarily suspended Tysabri from the market and ongoing trials in late February following reports of death linked to progressive multifocal leukoencephalopathy. Two of the patients with confirmed cases of PML had received Avonex and Tysabri for over two years as part of the Phase III trial. The company is conducting an ongoing safety study to determine whether there is a possible link between Tysabri and PML.

• Biosignal Ltd., of Sydney, Australia, and Q.Stat Pty. Ltd., of Melbourne, Australia, demonstrated in initial testing that Biosignal's anti-biofilm compounds are effective in preventing biofilm formation and corrosion of metals caused by sulphur-reducing bacteria and fungi.

• Cobra Biomanufacturing plc, of Keele, UK, said the UK Medicines and Healthcare products Regulatory Agency extended the license for its Oxford facility to include sterile dosage forms. That extends Cobra's rights to manufacture biopharmaceuticals, vaccines, gene therapy products and allergens for clinical use.

• Diurnal Ltd., of Sheffield, UK, received European orphan drug designation for its formulation of hydrocortisone for treating congenital adrenal hyperplasia. The formulation allows for the controlled and sustained release of the drug in a manner that mimics the normal physiological circadian rhythm. The rhythm, characterized by high levels in the morning and low levels at night, is lost in patients with adrenal insufficiency.

• Epimmune Inc., of San Diego, was notified by Syngenta AG, of Basel, Switzerland, that all conditions had been met for the assignment of certain portions of Epimmune's existing agreement with Aeres Biomedical Ltd., of London, to Syngenta. The assignment and restructuring of certain commercial terms of the agreement triggered an undisclosed payment to Epimmune by Syngenta.

• Evotec AG, of Hamburg, Germany, and Almirall Prodesfarma SA, of Barcelona, Spain, entered a two-year library synthesis agreement. Evotec will design and synthesize for Almirall several-thousand drug-like compounds across a range of chemical templates. Also, Evotec and Procter & Gamble Pharmaceuticals Inc., a subsidiary of Cincinnati-based Procter & Gamble Co., entered agreements whereby Evotec will provide pharmaceutical discovery and chemical development services. P&G will access discovery and preclinical expertise offered by Evotec, ranging from assay development, screening, medicinal and computational chemistry to scale-up and pharmaceutical manufacture. The companies started a relationship at the end of 2004 with a pilot screening program for a P&G therapeutic target.

• German government and opposition failed to compromise on a bill regulating agricultural biotechnology. The bill had been stalled in the upper house of the country's parliament, which is controlled by the opposition. Regulations are necessary to implement a European Union directive dating from 2002, but German politicians have not been able to agree on the details. The legislation will not be taken up again before national elections, which are expected Sept. 18.

• GlycArt Biotechnology AG, of Zurich, Switzerland, said F. Hoffmann-La Roche Ltd., of Basel, Switzerland, signed an agreement to acquire GlycArt. Roche will pay about CHF235 million (US$180.7 million) in cash in exchange for all outstanding capital stock of the privately held company. GlycArt was founded in 2000 to develop a new generation of antibody products using its GlycoMAb technology, designed to increase the biological activity of therapeutic antibodies for the treatment of cancer and autoimmune diseases.

• Igeneon AG, of Vienna, Austria, and Celltrion Inc., of Incheon, South Korea, signed a licensing and commercialization agreement and a deal related to the manufacturing, marketing and distribution of Igeneon's clinical product candidate IGN311. Igeneon is a wholly owned subsidiary of Aphton Corp., of Philadelphia, and IGN311 is a humanized monoclonal antibody targeting the Lewis Y antigen that is being developed as a potential new therapy for the treatment of certain epithelial tumors. Igeneon granted Celltrion a license to commercialize IGN311 in certain Asian countries, including Japan. In return, Igeneon gets from Celltrion milestone payments totaling $6 million. Celltrion will provide development and manufacturing services related to the optimization and up-scaling of the compound and will produce material for further clinical development. Celltrion will manage clinical development activities in Asia. Igeneon gets royalties on sales as part of the transaction, expected to close on Oct. 1.

• KuDOS Pharmaceuticals Ltd., of Cambridge, UK, said the first patient was treated in a Phase I study of its oral polyADP ribose polymerase inhibitor. The study will investigate safety and tolerability in patients with solid tumors, and establish the appropriate dose using a new technique to measure inhibition of the enzyme the drug targets.

• Mesoblast Ltd., of Melbourne, Australia, said it entered an agreement with Colorado State University to perform preclinical dose-escalation trials of its universal donor adult stem cell technology for the treatment of long bone fractures, and for intervertebral spinal fusion. The trials are expected to begin before the end of August, with the first results to be available within five months of initiation.

• Mologen AG, of Berlin, appointed Dirk Simon to the company's board of management, with responsibility for finance. Simon joins Mologen from Merckle Group, where he was responsible for financial oversight of business development, as well as research and development. The company also appointed Matthias Schroff to the board, with the title of chief operating officer, a new position. Schroff is one of the inventors behind Mologen's key patents and served as managing director before the company went public.

• MorphoSys AG, of Munich, Germany, appointed Robert Friesen director of preclinical development, and Bernhard Erning as director of treasury and corporate development. Friesen joins from the Dutch biopharmaceutical company AM-Pharma BV, where he had been vice president of research and preclinical development. Erning previously was head of equity capital markets for WestLB, of Duesseldorf, Germany, and executive director of corporate finance for UBS in London and Frankfurt, Germany.

• Newron Pharmaceuticals SpA, of Milan, Italy, completed patient enrollment in its Phase III trial with safinamide to treat Parkinson's disease. A total of 260 patients in 26 centers worldwide have been randomized in the study, which aims to show safety and efficacy of safinamide used as adjunctive treatment to a dopamine agonist in early stage Parkinson's disease patients. Data should be available in the first half of 2006.

• NicOx SA, of Sophia-Antipolis, France, said several compounds have been selected for further development from the company's agreement with New York-based Pfizer Inc. to develop nitric oxide-donating compounds for ophthalmology. Those compounds, submitted by NicOx, will be tested by Pfizer to identify a possible candidate for clinical development. The companies signed the agreement in August 2004, with Pfizer receiving the option to obtain an exclusive worldwide license to the compounds. NicOx has received €2 million (U.S. $2.4 million) so far, and stands to receive a further €35 million, plus royalties if the collaboration results in a commercialized product.

• Oxford BioMedica plc, of Oxford, UK, said the UK Motor Neurone Disease Association has awarded the company a research grant to support preclinical evaluation of MoNuDin to treat amyotrophic lateral sclerosis. The initial grant of £350,000 will fund a preclinical efficacy study and support preparations for clinical trials. Oxford BioMedica plans to start clinical development in the 2006-2007 timeframe.

• Oxford Immunotec Ltd., of Oxford, UK, said its core T-SPOT patent was upheld by the European Patent Office following a challenge by Cellestis Inc., of Valencia, Calif., and Sanofi-Pasteur, of Lyon France. T-SPOT is a method for quantifying antigen-specific T cells, thus providing a means of monitoring the response of the immune system to disease.

• Perlegen Sciences Japan KK, of Tokyo, and RIKEN (The Institute of Physical and Chemical Research) in Japan formed a high-throughput research collaboration using technology from Santa Clara, Calif.-based Affymetrix Inc. to conduct whole-genome association studies aimed at identifying the genetic causes of up to 47 diseases. Perlegen will work with RIKEN's SNP Research Center to conduct first-pass genome scanning of patients to identify regions of the genome associated with many diseases.

• Sareum Holdings plc, of Cambridge, UK, agreed to develop novel cancer therapeutics with the Institute of Cancer Research and Cancer Research Technology Ltd. Sareum will use its high-throughput protein expression, structure determination and medicinal chemistry to identify compounds that block a pathway involved in the development of resistance to chemotherapy that occurs in more than half of solid tumor types.

• Schwarz Pharma AG, of Monheim, Germany, will use Telomics technology from KeyNeurotek AG, of Magdeburg, Germany, to characterize drug candidates for its urology program. The technology is a tissue-based screening resource for preclinical development. Financial details were not disclosed.

• Stem Cell Sciences plc, of Edinburgh, UK, said the U.S. Patent Office granted additional claims to its Stem Cell Selection technology. The new claims cover methods of enriching any type of mammalian stem cell, from any cell source, based on introduced genes such as fluorescence markers or cell-surface proteins. The extension gives the U.S. patent similar scope to its European counterpart.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, is acquiring Miami-based generics company, IVAX Corp., for about $7.4 billion. As a result of the transaction, IVAX shareholders will own about 15 percent of Teva on a fully diluted basis. The companies' boards have approved the transaction, which involves a triangular merger structure that will cause IVAX to become a subsidiary of Teva. The acquisition is expected to close in late 2005 or early 2006.

• Transgene SA, of Strasbourg, France, said Merck & Co. Inc., of Whitehouse Station, N.J., met a clinical development milestone for a vaccine candidate constructed with Transgene's homologous recombination technology. The technology enables the efficient generation of recombinant viral vectors, in particular adenovirus vectors, which can be used in recombinant vaccines and in vitro diagnostics, among other applications. The parties entered the nonexclusive license for the technology in January 2003.

• U3 Pharma AG, of Martinsried, Germany, appointed Joanna Horobin chief executive officer. She joins U3 Pharma from MPM Capital LP, of Boston, where she was "entrepreneur in residence." U3's focus is signal transduction, and the company is working on novel therapies for the treatment of cancer and other hyperproliferative disorders.

• UK government announced the formation of Enterprise Capital Funds (ECF) in which funding from business angels and venture capitalists will be matched by government money, for investment in start-ups seeking up to £2 million (US$3.5 million) in funding. Up to £200 million will be made available through ECF. The government will provide up to twice the amount of private money committed to each fund, taking a share of any profit.

• VASTox plc, of Oxford, UK, said it started a drug discovery program in treating spinal muscular atrophy, its third proprietary program alongside Duchenne's muscular dystrophy and tuberculosis. The company is developing a chemical genomic screen using Drosophila, which will be used to identify compounds from its proprietary neuromuscular chemical library.

• York Pharma plc, of Hitchin, UK, acquired patents and know-how relating to sphingosine-1-phosphate (S1P) in the treatment of hyperproliferative skin disorders such as acne, from Monika Schaefer-Korting, of the Freie Universitat Berlin in Germany. They will collaborate on the product, a lipid found in blood and skin, which is involved in the proliferation of skin cells. S1P has a dual mechanism of action, preventing overproduction of corneocytes at the entrance of sebaceous follicle ducts.

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