• Aeres Biomedical Ltd., of London agreed to co-develop one of its humanized antibodies with the biopharmaceutical arm of Syngenta AG, of Basel, Switzerland. Financial terms were not disclosed.

• Allos Therapeutics Inc., of Westminster, Colo., and Loures, Portugal-based Hovione entered a long-term manufacturing agreement for the supply of Efaproxyn bulk drug substance, efaproxiral sodium. The drug is the subject of a confirmatory Phase III trial designed to compare the effect of whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn in women with brain metastases originating from breast cancer.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., signed an amendment to its agreements with Garching Innovation GmbH, the licensing agent for the Max Planck Society in Germany. The amendment reinforces Alnylam's continued exclusivity for the "Tuschl II" patent application, and improves the operating flexibility for the company's subsidiary, Alnylam Europe AG. The patent is required for development and commercialization of RNAi therapeutics.

• Amarin Corp. plc, of London, said that the Huntington Study Group began recruitment for the U.S. Phase III trial of Miraxion in Huntington's disease. The HSG will be conducting a clinical study of ultra-pure ethyl-EPA in people 35 years of age or older who have mild to moderate Huntington's disease. The HSG is a worldwide, not-for-profit group of physicians and other clinical researchers.

• Ardana plc, of Edinburgh, UK, signed a marketing agreement giving Cytochemia AG, of Ihringen, Germany, exclusive rights to market its testosterone replacement therapy, Striant, in Germany. Financial terms were not disclosed, but Ardana will receive an up-front payment and ongoing revenues for supplying the product

• Ark Therapeutics Group plc, of London signed an agreement with BL&H Co. Ltd. giving the South Korean company marketing rights for Kerraboot, Ark's wound care product that incorporates vascular endothelial growth factors. BL&H will purchase the product from Ark, which will receive a double-digit royalty on sales.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Taconic Farms Inc., of Germantown, N.Y., formed an alliance for the generation, marketing and delivery of genetically engineered rodents. The alliance combines Artemis' technology platform in mouse genetics and genomics with Taconic's expertise in rodent breeding, quality control, global marketing and distribution.

• Avantogen Ltd., of Sydney, Australia, said Endocyte Inc., of West Lafayette, Ind., will pay its first milestone payment to the company for Avantogen's submission of a drug master file to the FDA for its vaccine adjuvant GPI-0100. Avantogen reported the submission on April 7 in Australia. Endocyte is Avantogen's partner and licensee for the use of GPI-0100 in an immunotherapy for kidney cancer.

• BioInvent International AB, of Lund, Sweden, initiated Phase I/IIa studies of BI-201 to treat HIV infection. The first patients at Chelsea & Westminster Hospital in London have received the first dose. The trial will assess safety, tolerability and pharmacokinetic properties, as well as the effect on the viral load. The study is expected to be presented in the second quarter of 2006. BI-201 is a human antibody selected from the company's n-CoDeR antibody library for its ability to bind to the TAT protein.

• BioLineRx Ltd., of Jerusalem, said it exclusively in-licensed two therapeutic candidates: BL-2030, a soluble receptor that targets multiple types of cancer, licensed from BioRap Technologies Ltd. in Israel, and BL-2040, a small molecule to treat metabolic syndromes, licensed from Yeda Research and Development Company Ltd., the technology transfer of the Weizmann Institute of Science.

• Borean Pharma A/S, of Aarhus, Denmark, raised a total of €5.5 million (US$6.7 million) in a Series A private equity financing, including the most recent €1.5 million from new investor ABN Amro. Sander van Deventer, of ABN Amro, will join the company's board. Borean develops compounds and antibody analogues that can be produced in E. coli.

• Carna Biosciences Inc., of Kobe, Japan, and CrystalGenomics Inc., of Seoul, South Korea, signed a service agreement with South San Francisco-based Rigel Pharmaceuticals Inc. in the field of structure-based design, which focuses on structural analysis of disease targets in the presence or absence of therapeutic compounds.

• Cellectis SA, of Romainville, France, which has had a patent dispute with Johns Hopkins University and Richmond, Calif.-based Sangamo Biosciences Inc. involving targeted recombination and gene correction, said it has won the latest decision by the European Patent Office. The EPO revoked Sangamo's patent, titled "Functional Domains in Flavobacterium okeanokoites Restriction Endonuclease," due to the lack of an inventive step, Cellectis said.

• Compugen Ltd., of Tel Aviv, Israel, is collaborating with Biosite Inc., of San Diego, for the development and commercialization of diagnostic products. Biosite got a license to immunoassay-based diagnostic products using biomarkers discovered by Compugen. Compugen is expected to provide Biosite with data on several gene targets to be nominated by Biosite.

• Cortex Biochem Inc., of Raleigh, N.C., established an exclusive distribution and limited license agreement with Bouty SpA, of Milan, Italy. The agreement allows Bouty and its subsidiary biotechnology division, Technogenetics SrI, to promote, market and sell Cortex Biochem's MagaZorb nucleic acid isolation kits and associated reagents in Italy.

• CyGenics Ltd., of Melbourne, Australia, said it formed a new subsidiary, CytoVations, headquartered in New Jersey, to address needs of the U.S. cell therapy market. CytoVations will assess intellectual property and assist with the development of products, and is designed to complement the work of two CyGenics' divisions, specifically Boston-based Cytomatrix, which focuses on cell therapeutics, and Singapore-based Cell Sciences, which develops consumable cell culture products.

• Diabetica Ltd., of Coleraine, Northern Ireland, raised an undisclosed amount of funding from UUTech Ltd., the technology transfer arm of the University of Ulster, and Seroba BioVentures, of Dublin, Ireland. The company, a spin-out from the University of Ulster, has a lead program in diabetes based on glucose-dependent insulinotropic polypeptide molecules. The company, which was established in 2004, is commercializing the work of scientific founders Peter Flatt, Finbarr O'Harte and Neville McClenaghan from the university.

• DiaGenic ASA, of Oslo, Norway, said results of a study into the expression of 37 genes that can pinpoint whether a woman has breast cancer showed that the cancer was accurately diagnosed in at least 82 percent of patients. DiaGenic said the genes are not specifically cancer genes or involved in the tumor, and the discovery could lead to a blood test designed to detect breast cancer earlier than mammograms. The results were published in the June 14, 2005, issue of Breast Cancer Research.

• Endotis Pharma, of Paris, received €4 million (US$4.9 million) in a Series A financing round from investor Sofinnova Partners, also of Paris. Founded in February 2003, Endotis specializes in glycoscience, which includes the exploitation of protein-sugar interactions, in discovering and developing therapeutics for cancer and inflammatory diseases. The funding will be used to build up the company's team and facilities, as well as accelerate the development of antibodies against Endocan, a proteoglycan believed to be involved in tumor progression.

• Flamel Technologies SA, of Lyon, France, filed a patent application in the U.S. covering the combination of its proprietary formulation of aspirin, Asacard, and a COX-2 inhibitor comprising both conventional and selective COX-2 inhibitors.

• Galapagos NV, of Mechelen, Belgium, entered a services agreement with Celera Genomics Group, of Rockville, Md. Galapagos' services division, Galadeno, will provide technology and adenoviral reagents enabling Celera to analyze gene function in human cells and validate potential drug targets. Galadeno will receive payments related to its services and technology. Galadeno will construct recombinant adenoviruses harboring genes selected by Celera. The viruses will be used to introduce the genes to evaluate their function.

• Gene Bridges, of Dresden, Germany, and Covalys Biosciences AG, of Witterswil, Switzerland, formed a collaboration to develop "Copy & Paste" DNA engineering kits to generate SNAP-tag fusion proteins based on Gene Bridges' Red/ET recombination technology.

• Gentium SpA, of Villa Guardia, Como, Italy, priced its initial public offer of 2.4 million American depository shares at $9 each, raising $21.6 million. The shares represent 2.4 million of Gentium's ordinary shares. Its lead product, defibrotide, is set to enter Phase III testing in the U.S. and Europe to treat veno-occlusive disease. Underwriters have an overallotment option for up to 360,000 additional ADSs, which will be listed on the American Stock Exchange under the symbol "GNT."

• GNI Ltd., of Tokyo, and Shanghai Genomics Inc., of Shanghai, China, have merged their drug development technologies to streamline GNI's discovery, preclinical and clinical programs. Christopher Savoie will serve as CEO of GNI, while Ying Luo will be the company's president and Jun Wu will be appointed chief scientific officer. Along with the merger, GNI completed a private equity financing round of more than $13 million, led by U.S. and Japanese equity firms.

• Insilico GmbH, of Vienna, Austria, and the German Resource Center for Genome Research (RZPD) in Berlin are working on a joint project to link Insilico's SQL-based MASI database with RZPD's material index. The cooperative effort will allow researchers the ability to cross-reference sources, and to identify research material suitable for solving biological problems. MASI integrates information on RNA, DNA and proteins, as well as their native tissues and cells.

• Ipsat Therapies, of Helsinki, Finland, said Tekes, the Finnish National Technology Agency, will provide €3 million (US$3.6 million) in funding to support Ipsat's development, focusing on its lead product, P1A, through Phase IIb studies. P1A is a recombinant enzyme for the prevention of microflora gut disturbance and antibiotic-associated diarrhea and preservation of colonization resistance.

• Kalypsys Inc., of San Diego, and NovImmune SA, of Geneva, formed a collaboration to accelerate the discovery and development of new drugs for autoimmune and inflammatory diseases. The companies will work to find small-molecule modulators of the major histocompatibility complex II in patients with the diseases. Financial terms were not disclosed.

• Kara Bio AB, of Huddinge, Sweden, initiated Phase I studies of KB2115, which is being developed for obesity and dyslipidemia. The trial will be a randomized, double-blind, placebo-controlled study in healthy but overweight males and females with elevated blood lipids.

• Life Science Partners, of Amsterdam, the Netherlands, announced the first closing of its third fund, LSPIII, at €65 million (US$78.9 million). The fund, which focuses primarily on biotechnology investments in the Benelux region, Germany and other parts of Europe, already has completed four transactions: Octoplus NV, of Leiden, the Netherlands; Jerini AG, of Berlin; Idea AG, of Munich, Germany; and Zealand Pharma A/S, of Glostrup, Denmark. All have a near-term exit horizon, Life Science Partners said. It will invest in 15 to 20 companies in total.

• MNLpharma Ltd., of Reading, UK, said preclinical studies evaluating several antifungal compounds showed that terbinafine-resistant strains of S. cerevisiae were highly susceptible to MNL's compounds. Data demonstrated an activity profile and a mechanism that potentially is different than existing products. The results were presented at the BIO 2005 meeting in Philadelphia.

• Napo Pharmaceuticals Inc., of South San Francisco, said it has granted AsiaPharm Group Ltd., of Singapore, an exclusive license to develop and commercialize products derived from crofelemer in China. Crofelemer targets gastrointestinal indications and is in advanced development in the U.S. to treat AIDS-related diarrhea and diarrhea-predominant irritable bowel syndrome. Under the agreement, AsiaPharm will contribute process development, manufacturing and pediatric formulation expertise, and has made an equity investment in Napo. AsiaPharm also will make royalty payments from sales of crofelemer-derived products in China.

• NicOx SA, of Sophia-Antipolis, France, appointed Ali Raza head of research and development. He will be responsible for the research, drug development and clinical development departments and thus drive the company's product development strategy. Raza previously was head of clinical development and regulatory affairs at Renovo Ltd., of Manchester, UK, and before that spent 14 years with London-based AstraZeneca.

• Nonlinear Dynamics Ltd., of Newcastle upon Tyne, UK, said the Australian Proteome Analysis Facility Ltd. has purchased two full licenses of Progenesis Discovery v2005, Nonlinear's flagship product. The product is a 2D gel image analysis platform that uses statistically driven proteomics and tools for data analysis.

• Onyvax Ltd., of London announced further data from its Phase II trial of Onyvax-P, a vaccine for treating prostate cancer, showing it may delay progression of the disease in hormone-resistant cancer. Forty-two percent of patients showed prolonged decreases in levels of increase of prostate-specific antigen.

• Prana Biotechnology Ltd., of Melbourne, Australia, said it will continue to develop PBT2 for Alzheimer's disease, and is confident it will not present impurity problems found in PTB1. The company began Phase I trials of PBT2 in March, and it continues to be focused on developing and commercializing a range of metal-protein attenuating compounds to treat neurodegenerative diseases. In other news, Jonas Alsenas has stepped down as Prana's CEO and director to pursue other opportunities. Geoffrey Kempler will re-assume the positions of executive chairman and CEO until a successor is found.

• ProImmune Ltd., of Oxford, UK, donated reagents based on its Pro5 MHC (major histocompatability complex) Pentamer technology to researchers at the MRC Human Immunology Unit in Oxford for an HIV vaccine development program. ProImmune's technology is designed to detect and separate T cells from blood samples, according to the specific disease cells they recognize, to track immune system responses.

• Prolysis Ltd., of Oxford, UK, and Essential Science Ltd., of Glasgow, UK, agreed to extend their collaboration for the commercialization of Prolysis' antibiotic development programs. In the year since the companies began working together, they said they have validated Prolysis' approach to anti-infectives through an investment from Tokyo-based Astellas Pharma Inc. The extended agreement will focus on opportunities to out-license Prolysis' research technologies and programs or in-license development candidates.

• pSivida Ltd., of Perth, Australia, entered a collaboration with the Ian Wark Research Institute at the University of South Australia to evaluate its BioSilicon platform for the delivery of protein and peptide-based therapeutics. The company said its preliminary investigations using BioSilicon have indicated its potential for the development of controlled-release formulations of existing therapeutics.

• Qiagen NV, of Venlo, the Netherlands, completed the acquisition of Beijing-based Tianwei Times, a privately held company that manufactures and supplies nucleic acid sample preparation consumables. Under the terms of the agreement, Qiagen has acquired certain assets of Tianwei for about $2 million in cash, plus potential earn-outs estimated at about $2 million over two years. Qiagen expects to incur one-time charges relating to the acquisition of $500,000 in the third quarter. The transaction is pending approval by the Chinese government.

• Revotar Biopharmaceuticals AG, of Brandenburg, Germany, said the European Medicines Agency granted orphan drug designation to bimosiamose disodium, its pan-selectin antagonist for the treatment of acute lung injury. The designation provides Revotar with 10 years of marketing exclusivity if its drug is approved in the European Union.

• SkyePharma plc, of London, said the German regulatory authority has approved Foradil Certihaler (formoterol fumarate inhalation powder) for the treatment of asthma and chronic obstructive pulmonary disease. The product was co-developed by Novartis Pharma AG, of Basel, Switzerland.

• Speedel Group, of Basel, Switzerland, developed next generation renin inhibitors for the treatment of cardiovascular and metabolic diseases, triggering a milestone payment. Working together with Locus Pharmaceuticals Inc., of Blue Bell, Pa., under a collaboration initiated in 2003, Speedel produced a series of lead compounds (SPP800 series) for which it has filed a patent application.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, said it initiated dosing in a Phase Ib trial for TG-873870, a quinolone antibiotic with the potential for treating drug-sensitive and drug-resistant bacterial infections. The multi-dose tolerance and safety study is being conducted in the U.S.

• YM BioSciences Inc., of Mississauga, Ontario, said its subsidiary, CIMYM Inc., partnered with Kuhnil Pharmaceutical Co., of Seoul, South Korea, to expand the development program for nimotuzumab (TheraCIM-hR3), its monoclonal antibody against the EGF receptor for certain patients with non-small-cell lung cancer. Kuhnil expects to file an investigational new drug application in Korea this year for a Phase II study in NSCLC patients who are unfit for chemotherapy, and CIMYM expects to file in Canada and elsewhere for additional studies of the drug.

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