• Acambis plc,of Cambridge, UK, said it started a Phase I clinical trial of its universal influenza vaccine ACAM-FLU-A targeting all A strains of the flu virus. The randomized, double-blind, placebo-controlled, multicenter trial in the U.S. will investigate safety, tolerability and ability to generate an immune response in up to 80 healthy subjects and assess two alternative adjuvants. The vaccines uses a hepatitis B core protein to deliver M2e, the extracellular domain of the ion channel protein M2, which is highly conserved in all A strains of the flu virus.

• Ark Therapeutics plc, of London, withdrew its application for early marketing approval of Cerepro, its treatment for malignant glioma, under the exceptional circumstances route, following confirmation from the European Medicines Agency that data from the ongoing Phase III trial are required for approval. The company now expects to file in 2008.

• Arpida Ltd., of Basel, Switzerland, entered an agreement to acquire privately held TLT Medical Ltd., of Reinach, Switzerland. TLT is developing a therapy to treat onychomycosis, or fungal infections of the nails of the fingers and toes. It is a novel formulation of terbinafine (the active ingredient of Lamisil) that is expected to enter a pivotal Phase III trial in Europe in the near term. The deal would entail an up-front payment to TLT as well as potential milestone payments that together could total up to CHF57 million (US$47.5 million). Up to CHF5 million of that would be paid in Arpida shares, with the remainder in cash. The deal is expected to close by mid-August. Earlier this week Arpida reported positive Phase III data on intravenous iclaprim, a broad-spectrum antibiotic for treating complicated skin and skin structure infections. A new drug application filing is expected later this year.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said U.S. and European regulatory authorities accepted its new drug application and marketing authorization application for ceftobiprole (BAL5788) in the treatment of complicated skin and skin structure infections. The applications were submitted by Basilea's partners Johnson & Johnson Pharmaceutical Research and Development LLC, of New Brunswick, N.J., in the U.S. and Janssen-Cilag International NV, of Beerse, Belgium, in Europe. Both applications will be subject to a standard review. Ceftobiprole is an anti-MRSA, broad-spectrum, cephalosporin antibiotic designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity toward MRSA and penicillin-resistant Streptococcus pneumoniae.

• BioLineRx Ltd., of Jerusalem, and the University of Illinois at Champaign-Urbana have entered into an exclusive worldwide licensing agreement to research, develop and commercialize BL-4030, a small molecule for treating cancer. Financial terms were not disclosed. BL-4030 is designed to induce apoptosis by activating a specific protein called procaspase 3. The compound takes advantage of the fact that procaspase 3 levels are highly elevated in certain cancers, and activation of procaspase 3 may kill only malignant cells and spare normal cells that have low levels of the apoptotic protein. Cancers with elevated levels of procaspase 3 include lung and breast cancer, certain lymphomas, melanoma and certain liver and nervous system cancers.

• Biotica Technology Ltd., of Cambridge, UK, said its appeal against a modular polyketide synthase engineering patent had been successful, and the European Patent Office (EPO) Board of Appeal had revoked the patent in its entirety. "This final decision by the EPO clears the way for our polyketide engineering technology in Europe, for which we have our own strong IP portfolio, and will allow us to further broaden its scope," said Peter Leadlay, co-founder and director of Biotica.

• Cancer Research Technology Ltd., of London, the commercialization arm of the charity Cancer Research UK, announced a research collaboration with AstraZeneca plc, also of London, to develop optical imaging techniques for use in cancer research. The three-year collaboration, funded by AstraZeneca, also of London, will focus on the development of real-time fluorescence and confocal imaging techniques. The aim is to develop non-invasive imaging technologies for studying tumor progression, including the investigation of tumor development, invasion and metastasis. The collaboration initially will involve the development and validation of fluorescent probes and reporters for deep tissue imaging of specific biological targets. They will be further developed for the detection of tumor cells, identification of apoptosis or assessment of blood flow. Ultimately, the studies aim to investigate the mechanisms of tumor invasion and assess the effects. In addition, methods and software for quantifying image data will be developed.

• Crucell NV, of Leiden, the Netherlands, has created two business units, for vaccines and proteins. Björn Sjöstrand was named to head the vaccines unit. He was CEO of SBL Vaccines, which was acquired by Crucell in November 2006. Arthur Lahr will head the protein unit. He was Crucell's chief strategy officer and executive vice president of sales and business development.

• DeCode Genetics Inc., of Reykjavik, Iceland, with researchers at Emory University in Atlanta, have identified the first gene associated with restless leg syndrome. The researchers report a population-attributable risk for RLS of at least 50 percent, and said the variant is common, with almost 65 percent of the population carrying at least one copy. A report was published July 18 in the online edition of the New England Journal of Medicine and will appear in an upcoming printed edition.

• DeltaDOT Ltd., of London, said it is joining a U.S./UK-based consortium that has been awarded a grant from DARPA to develop technology and processes to accelerate the production of vaccines and protein therapeutics, reducing long term storage issues and enhancing the response to a wide variety of biological threats. The DARPA program, the Accelerated Manufacture of Pharmaceuticals, intends shorten the time taken to manufacture vaccines and monoclonal antibodies. The consortium, led by Xcellerex Inc., of Marlborough, Mass., has been awarded $7.9 million for the first phase of the program to demonstrate small-scale production and analytical systems capabilities. DeltaDOT's protein stability technology platforms will provide the analytical capabilities required to track product quality throughout the process. The company's Peregrine system is able to monitor unlabeled proteins directly in real time, while its Osprey analyzer characterizes their properties.

• Elan Corp. plc, of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., said they were informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use adopted a negative opinion on the marketing application for the use of Tysabri (natalizumab) in patients with Crohn's disease. The companies plan to appeal the opinion, with a decision on that appeal expected by the first quarter of 2008. The companies filed for approval in Crohn's disease in the U.S. in December. The FDA is holding an advisory committee to discuss the application on July 31. The product is approved for treating multiple sclerosis.

• Evotec AG, of Hamburg, Germany, said it expanded its sterile pharmaceutical manufacturing facility in Glasgow, Scotland. The company has doubled its capacity for the aseptic GMP manufacture of pharmaceuticals to be used in clinical trials. The expansion is in response to demands from clients for clinical supplies of liquid and lyophilized drug product, Evotec said.

• Galapagos NV, of Mechelen, Belgium, said its BioFocus DPI service division received an undisclosed milestone payment in the autoimmune discovery research collaboration with Ingelheim, Germany-based Boehringer Ingelheim GmbH. The three-year collaboration, signed in January 2006, involves an expansion of BioFocus DPI's SilenceSelect sh-RNA-based gene collection with an additional gene set, the development of a dedicated cellular assay in the field of autoimmune diseases and its application in a target discovery screen for BI's autoimmune discovery research. Galapagos obtained up-front fees and will continue to get research and development funding, plus additional milestone fees when certain drug discovery criteria are met. Should all criteria be achieved, payments to Galapagos could exceed €2 million (US$2.8 million).

• Glenmark Pharmaceuticals SA, of Mumbai, India, has completed the purchase of two new biological entities, CHR-1103 and CHR-1201, from Chromos Molecular Systems Inc., of Burnaby, British Columbia. The two entities are humanized monoclonal therapeutic antibodies. Glenmark has purchased all rights to the two products as well as rights to use Chromos' proprietary ACE System technology for cell line development with CHR-1103 and CHR-1201. Glenmark holds the worldwide rights for further development, registration and commercialization of those products. Financial terms were not disclosed. The two compounds are part of a class of drugs known as selective adhesion molecule inhibitors. Glenmark plans to initiate Phase I trials in 2008 and complete Phase I on CHR-1103 by March 2009. CHR-1201 is an anti-thrombolytic humanized monoclonal antibody, which Glenmark plans to develop initially to treat acute stroke, starting with a Phase I trial by March 2009.

• Grifols SA, of Barcelona, Spain, and Cerus Corp., of Concord, Calif., have entered into an agreement to commercialize Cerus' Intercept Blood System in Spain and Portugal. The system is designed to provide increased protection from a broad range of transfusion-transmitted pathogens. Under terms of the agreement, Grifols and Cerus will sell, deploy and support the system in Spanish and Portuguese blood centers. In addition, Grifols will be responsible for servicing the Intercept system illuminators and will manage the supply chain through its distribution sites in Spain and Portugal. Financial details were not disclosed.

• Dr. Hadwen Trust, a UK medical charity that works to reduce the use of animals in research, is teaming up with the universities of Manchester and York, and Kings College London, to develop methods to knock out genes in human tissues grown from mesenchymal stem cells in the laboratory, which could replace transgenic knockout mice. The trust said creation of transgenics is increasing the use of animals in research and has been criticized as having questionable relevance to human physiology. Researchers increasingly are encountering cases where human genes and mouse genes have unexpected different functions. The trust's projects will develop targeted gene silencing in human cells and tissues in the test tube, using RNA interference and other approaches.

• Haptogen Ltd., of Aberdeen, UK, and Pepscan NV, of Lelystad, the Netherlands, agreed to a research collaboration aimed at identifying monoclonal antibodies against membrane bound-protein targets. Membrane proteins, such as GPCRs, are an important class of drug targets. However, they are difficult to raise antibodies against, and to date there is no systematic way of developing functional monoclonals against membrane proteins. The collaboration will combine both companies' expertise in epitope presentation and antibody generation with the aim of creating antibodies against a variety of targets linked with GPCRs, for both in-house and third-party licensing.

• KeyGene NV, of Wageningen, the Netherlands, has established a joint lab for plant molecular breeding with the Shanghai Institutes for Biological Sciences (SIBS). The lab will operate within the Institute for Plant Physiology and Ecology of SIBS, a branch of the Chinese Academy of Sciences in Shanghai.

• Kreatech Biotechnology BV, of Amsterdam, the Netherlands, and NuGEN Technologies Inc., of San Carlos, Calif., signed an agreement that will enable NuGEN to market FL-Ovation cDNA Fluorescent Modules, designed to complement its family of Ovation RNA amplification products. The nonexclusive agreement calls for Kreatech to supply components for a NuGEN-validated fragmentation and labeling system for one- and two-color microarray analysis utilizing its patented Universal Linkage System technology for labeling with Cy3 and Cy5 mono-NHS esters licensed by NuGEN from UK-based GE Healthcare.

• Living Cell Technologies Ltd., of Melbourne, Australia, has established a Level 1 American Depositary Receipt Program (ADR) sponsored by the Bank of New York. The company's ADRs will trade under the ticker symbol LVCLY and was effective July 17, and each ADR will represent 10 ordinary LCT shares. The ADR program facilitates the purchase of LCT stock in the over-the-counter pink sheet market by U.S. investors, who already hold more than 10 percent of its shares.

• Proximagen Neuroscience plc, of London, was awarded a grant by the Michael J. Fox Foundation to pursue research into its gene therapy approach for treating Parkinson's disease. The grant program is supported by Elan Corporation plc, of Dublin, Ireland, which has first refusal to license the program. The grant will fund Proximagen's PRX4 program, which centers around a gene that produces a neuroprotective protein present in healthy individuals but lacking in patients with Parkinson's. The aim is to use a viral vector to deliver the gene directly into brain cells.

• Qiagen NV, of Venlo, the Netherlands, said its offer to exchange cash and stock for all outstanding shares of Digene Corp., of Gaithersburg, Md., expired as scheduled Friday. All conditions of the exchange offer have either been satisfied or waived, and Qiagen intends to accept all tendered shares. Preliminary tabulations indicated that the number of shares tendered constituted well in excess of 90 percent of the outstanding stock. Accordingly, Qiagen intends to complete its acquisition of Digene by merger without the approval of the Digene stockholders, promptly after its acceptance of the shares. Pro-ration calculations will be announced when completed, and payment for the Digene shares will be made as soon as practicable. In other news, Qiagen entered an agreement with the Joint Center for Structural Genomics to provide protein crystallographers with a new set of crystallization screens that have been assembled from analysis of hundreds of thousands of crystallization experiments. Financial terms were not disclosed.

• Rosetta Genomics Ltd., of Rehovot, Israel, expanded its Israeli research facility. The company is adding new laboratories to meet research and development needs for its microRNA-based diagnostic programs. The company said it expects to grow to about 70 employees by the end of the year.

• Solagran Ltd., of Sydney, Australia, has been notified by the Russian Ministry of Heath that the pharmaceutical registration of both Bioeffective and the associated medicine Ropren has been finalized. Ropren is a natural hepatoprotector, which will be used to treat chronic liver disease, including hepatitis and cirrhosis. The company said it next will pursue approval in the European Union.

• ValiRx plc, of London, has signed a memorandum of understanding with Brussels, Belgium-based BIO.Be for a joint venture to develop and commercialize products in the epigenomics sector. Under the terms of the agreement, ValiBIO SA, an oncology diagnostics company, is being created and located in Gosselies, Belgium. ValiRx will invest cash and equity in return for a 77 percent share of the equity of ValiBio. Also, the joint venture company will be financed by partly repayable government grants and loans. ValiRx said ValiBio will use the funds to build a team and laboratory facilities, and to develop HyperGenomics-based cancer diagnostic products. Financial details were not disclosed.

• Vastox plc, of Oxford, UK, changed its name to Summit Corp. plc to reflect the growth and development of its drug pipeline and its core technology capabilities. The name change was approved by shareholders last week.

• Xceleron plc, of York, UK, said it signed the lease on a facility in Germantown, Md., to house an accelerator mass spectrometer and associated facilities for analyzing Phase 0 clinical trials. The company's technology makes it possible to measure the absorption, distribution, metabolism and excretion of drugs administered to humans in microdose quantities, down to monitoring the fate of a single molecule. Studies have consistently shown data linearity between Phase 0 microdosing and traditional Phase I pharmacokinetic studies.