• Affitech AS, of Oslo, Norway, signed an agreement with Munich, Germany-basedMicromet AGfor a nonexclusive, worldwide sublicensable research license to the joint patent estate of Micromet and Bridgewater, N.J.-basedEnzon Pharmaceuticals Inc.in the field of single-chain antibodies (SCA). Affitech will have rights to conduct research involving SCA technology and will have sublicense rights to third parties to conduct research, develop or use an SCA product generated by Affitech. Terms were not disclosed. Also, Affitech gained a worldwide exclusive license fromPharmexa A/S, of Horsholm, Denmark, under which it gains certain intellectual property rights to recombinant antibody-like proteins called diabodies. Affitech will be entitlted to conduct further pre-IND research on the technology and to sublicense it to third parties. The two companies will share the proceeds from such agreements. Pharmexa gained the diabody technology from Marburg, Germany-basedVectron Therapeutics AGin December 2004.

• Allergy Therapeutics plc, of Worthing, UK, said it began dosing for its short course hay fever vaccine Pollinex Quattro in the pivotal U.S. Phase III ragweed allergy trial. The primary objective of the double-blind, randomized trial is to compare the efficacy and safety of Pollinex Quattro Ragweed vs. placebo. The single pivotal trial, if successful, is suitable for registration, with a Biologics License Application planned for the second half of 2008. The phase III trial follows a similar study with Pollinex Quattro Grass, which commenced earlier this year.

• Anavex Life Sciences Corp., of Geneva, entered a research agreement with the Department of Pharmacology and Biological Sciences at Paris 5 University-Rene Descartes in Paris to investigate the neuroprotective action of the company's tetrahydrofuranic compound ANAVEX 19-144 in transient focal cerebral ischemia animal models. The research program involves a preliminary study of the effects of the drug on mean arterial blood pressure and a main study on cerebral ischemia. Terms were not disclosed.

• Arpida Ltd., of Basel, Switzerland, said radiolabeled microdoses of AR-709 achieved good distribution within the lungs in a first-in-man study. The drug also showed a long half-life but low oral bioavailability, although Arpida will continue to consider oral, intravenous and inhaled delivery. AR-709 is a novel DHFR inhibitor with microbiological activity against streptococci and multidrug-resistant Streptococcus pneumoniae. Earlier this month, Arpida completed enrollment in its second Phase III trial of intravenous iclaprim in the treatment of complicated skin and skin structure infections.

• BioBase GmbH, of Wolfenbuttel, Germany, said it received a three-year, €3 million (US$4 million) European Union research contract to develop technology to analyze complex disease mechanisms. The project, called Net2Drug, will be coordinated by BioBase and developed as a collaboration with several institutions and universities in Europe. The project's goal is to create a toolbox integrating cutting-edge bioinformatics, chemoinformatics and experimental methods to identify potential therapeutic targets.

• Biota Holdings Ltd., of Melbourne, Australia, has filed documents in Australian courts, which it said provides details of its allegation that GlaxoSmithKline plc, of London, mismanaged its legal obligation to develop and market the antiviral drug Relenza (zanamivir). Biota claims that after Relenza's worldwide launch in 2000, GSK withdrew its support for the product, and the result is that Relenza now holds only a small portion of the estimated $2 billion annual global market for antiviral flu drugs. Biota said it is entitled to receive a 7 percent royalty on GSK's sales of Relenza.

• CeNeS Pharmaceuticals plc, of Cambridge UK, said it filed an investigational new drug application with the FDA for its morphine metabolite, morphine-6-glucuronide (M6G), in the treatment of postoperative pain. That follows the completion of European Phase III studies, which demonstrated advantages of using M6G compared to standard morphine, with M6G providing equivalent pain relief but causing fewer side effects than morphine. The opening U.S. trial will be a Phase I pharmacokinetic study in volunteers requested by the FDA, along with an additional pre-clinical toxicology analysis. In parallel to conducting those two small studies, CeNeS will complete the protocol design of the first U.S. Phase III trial. CeNeS is looking for a partner to collaborate and fund the Phase III U.S. trials and has appointed Rodman & Renshaw, the U.S.-based health care specialist investment bank, to assist in the process.

• Cerep SA, of Paris, has renewed its scientific collaboration with Eli Lilly and Co., of Indianapolis, for 2007. The research collaboration agreement signed between the two companies in February 2003 called for them to undertake an intensive profiling program to define the chemical space that is most suitable for use in discovering lead compounds that are active against important targets of pharmaceutical interest. As part of the collaboration, Lilly was given access to selected areas of Cerep's BioPrint database. The renewal of the deal means Lilly will continue to utilize Cerep's experience in high-throughput compound profiling to enhance its understanding of the fundamental relationships between chemical structure and biological activity. The financial terms were not disclosed.

• Cytheris, of Paris, appointed Bertrand Vannier chief financial officer and Thérèse Croughs chief medical officer. Vannier was previously CFO of Unither Pharmaceuticals, a French contract manufacturer, and has experience in the organization of IPOs and LBOs. Croughs is specialized in internal medicine and was previously responsible for European medical affairs at Paris-based BioAlliance Pharma. She will oversee all clinical development activities at Cytheris, whose lead compound, Interleukin-7, is undergoing Phase I/II clinical trials.

• Galapagos NV, of Mechelen, Belgium, reached two significant milestones in its multi-year drug discovery alliance with GlaxoSmithKline plc, of London, in osteoarthritis, triggering payments of €3.2 million (US$4.27 million) from GSK. The deal is worth up to €130 million in milestones for two marketable products to Galapagos, plus up to double-digit royalties on global product sales. In January, Galapagos announced the alliance's first milestone, triggering a €400,000 payment from GSK.

• Innate Pharma SA, of Marseille, France, reported a slight reduction in its net loss, to €6.04 million in 2006 from €6.13 million in 2005, despite a 75 percent jump in research and development outlays to €12.6 million from €7.2 million. Clinical development costs in particular bounded from €1.5 million to €5.1 million from one year to the next. At the same time, the company's operating income jumped by to €8.5 million last year from €2.4 million in 2005, mainly due to the license agreement it signed with Novo Nordisk A/S, of Copenhagen, Denmark, in March 2006. As at the end of 2006, the company had cash and cash equivalents of €59.8 million, as against €18.3 million the year before.

• MediGene AG, of Martinsried, Germany, filed for approval of Polyphenon E Ointment for genital warts in Germany, Austria and Spain. Clearance in those countries is supposed to be a reference for the submission of applications in additional European countries. The product is approved in the U.S., where it's scheduled to be launched in the second half of this year by MediGene's partner, Bradley Pharmaceuticals Inc., of Fairfield, N.J.

• Mymetics Corp., of Nyon, Switzerland, said its HIV vaccine elicited IgA mucosal antibodies in vaginal and rectal tissues in a nonhuman primate model. Mucosal IgA antibodies are considered a potential defense against HIV infection. Those data were presented at the Keystone Symposium on HIV Vaccines in Whistler, British Columbia. In other news, Mymetics signed an exclusive license with Pevion Biotech, of Bern, Switzerland, for the use of Virosomes, a market-approved carrier system for the delivery of active substances, in the production of its HIV vaccine. The use of Virosomes is expected to facilitate delivery of Mymetics' HIV vaccine without the use of an adjuvant. Terms of the deal were not disclosed.

• Nautilus Biotech SA, of Evry, France, initiated a Phase I clinical trial of subcutaneous Belerofon, its long-lasting human interferon (IFN) alpha, after the FDA approved the IND application it submitted last October. Belerofon has therapeutic potential in a number of disease areas, including chronic hepatitis C. The trial is being conducted in Austin, Texas, and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SC Belerofon in comparison with IntronA (marketed by Schering-Plough and Pegasys (pegylated interferon alfa-2a, of F. Hoffman-LaRoche). Nautilus submitted a second IND to the FDA in March for its oral formulation of Belerofon, which is one of several proteins the French company is developing for oral administration using its proprietary protein engineering technology.

• Neurotune AG, of Zurich, Switzerland, and Nikem Research Srl, of Milan, Italy, entered a 12-month service agreement at the start of February. Under the terms, NiKem will make its integrated platform available to Neurotune, including medicinal, parallel and analytical chemistry, exploratory ADMET profiling and in vivo pharmacokinetics. The collaboration aims to design, synthesize and optimize compounds against Neurotune proprietary target neurotrypsin. Financial terms were not disclosed.

• PARI Aerosol Research Institute, of Munich, Germany, changed its name to PARI Pharma GmbH. The changes was designed to highlight the focus on new and emerging drug therapies developed in conjunction with its eFlow electronic nebulizer and formulation technologies.

• Peakdale Molecular Ltd., of Chapel-en-le-Frith, UK, entered an agreement with EnBioTec Laboratories Co. Ltd., of Tokyo, to co-develop nuclear receptor-based lead compounds for drug discovery. EnBioTec has developed the Receptor Cofactor Assay System to investigate the interactions between nuclear hormone receptors, co-factors and ligands. Peakdale will provide a targeted set of compounds for RCAS and functional assay testing and will work with EnBioTec to synthesize compounds based on the subsequent test results. Terms of the deal were not disclosed.

• Pieris AG, of Freising-Weihenstephan, Germany, said its drug candidate PRS-050, a proprietary class of human binding proteins, has demonstrated potent anti-tumor activity. The positive results with PRS-050, a VEGF-specific Anticalin with extended serum half life, were achieved in a tumor xenograft model, supporting the development of a range of cancer indications. The compound exhibited a favorable binding and functional in vitro activity profile in comparison to all currently approved VEGF antagonists, the company said. Strong reduction of VEGF-induced enhanced vascular permeability after systemic administration of PRS-050 also was demonstrated in a second preclinical model. In both in vivo models PRS-050 was at least as efficacious as Avastin (bevacizumab, Genentech Inc. and F. Hoffman-LaRoche Ltd.). The data will be presented at CHI's forthcoming Protein Engineering Summit in Boston.

• Proteo Biotech AG, of Kiel, Germany, has received orphan drug status from the European Commission for its drug candidate Elafin for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. That gives the company exclusive marketing rights within the EU for up to 10 years. In addition, the designation allows access to a centralized approval procedure that will accelerate the process of approval in all EU states. The drug is a recombinant human protein.

• Rosetta Genomics Ltd., of Rehovot, Israel, said its microRNA extraction protocol from blood serum enables the sensitive detection of microRNAs with virtually no microRNA lost in the process. Data were presented at the Cambridge Healthtech Institute's microRNA in Human Disease and Development Conference in Boston. The company also presented data from its lead therapeutic program in liver cancer, in which several potential microRNA targets have been isolated that when inhibited in vitro can lead to a decrease in cancer cell proliferation. That program is partnered with Carlsbad, Calif.-based Isis Pharmaceuticals Inc.

• SR Pharma plc, of London, is changing its name to Silence Therapeutics to reflect its move into RNAi, initiated when it took over Atugen GmbH, of Berlin, in 2005. The S and R in the current name stand for Stanford and Rook, the surnames of the founders of the company, which was established originally to develop immunotherapeutics for cancer, infectious diseases and chronic inflammatory diseases, based on using mycobacterium vaccae as an immune potentiator. The company retains rights to the M. vaccae technology and is looking for development partners. Under its new moniker, SR Pharma expects to begin a trial of a systemically administered form of RNAi later this year.

• United Therapeutics Corp., of Silver Spring, Md., and Mochida Pharmaceutical Co. Ltd., of Tokyo, have signed an agreement for the exclusive distribution in Japan of Remodulin (treprostinil sodium) Injection administered subcutaneously or intravenously for the treatment of pulmonary arterial hypertension. Mochida will be responsible for obtaining marketing authorization, with United Therapeutics' assistance, including conducting necessary bridging studies. Upon receipt of marketing authorization and pricing approval, Mochida will purchase Remodulin from United Therapeutics for distribution in Japan at a price agreed to by the companies. Financial details were not disclosed.

• Vivalis, of Nantes, France, granted Bavarian Nordic A/S, of Kvistgard, Denmark, a license to evaluate its embryonic stem cell-derived ebx cell lines as a production platform for MVA-BN vaccines. Terms of the deal were not disclosed. MVA-BN is a multivalent vaccine vector for the development of vaccines against smallpox, HIV/AIDS, breast and prostate cancer. Bavarian Nordic is conducting Phase I and Phase II trials with MVA-BN-based vaccines, which are currently produced in chicken embryonic fibroblasts.