• AnalytiCon Discovery GmbH, of Potsdam, Germany, and Merck KGaA, of Darmstadt, Germany, entered an agreement whereby AnalytiCon will provide Merck with natural product lead-generation services until the end of 2009. AnalytiCon will apply its MEGAbolite technology to seek active compounds hits from a set of more than 10,000 extracts from plants and microorganisms. Resulting leads would be jointly developed through preclinical research. Terms. Targets of the deal were not disclosed.
• Ark Therapeutics Group plc, of London, said it has been given clearance by the U.S. Recombinant DNA Advisory Committee (RAC) for its planned Phase III U.S. clinical study of Trinam, its gene therapy to prevent haemodialysis access graft blockage. The company filed its application earlier this month, and a final decision had been expected by the end of RAC's public review process, scheduled for June 19-21. But after the initial review, RAC members said the application does not require discussion in a public session. An application will be submitted for special protocol assessment by the FDA, and the trial is expected to commence in the second half of the year.
• Avexa, of Melbourne, Australia, has been awarded a A$4.3 million (US$3.5 million) Australian government grant to develop a new generation of HIV antiviral drugs using fragment based drug design, a nontraditional research methodology. Avexa will work with the government's molecular and health technologies division to discover inhibitors of the HIV integrase enzyme, which conventional techniques are unable to identify. The program also can be applied to other antiviral targets. The grant program provides funding for up to half of eligible project expenditures for early-stage R&D. It also will help fund discovery and preclinical development required to advance candidates to proof-of-concept studies.
• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said the Swiss regulatory agency granted partner Janssen-Cilag AG, a London-based Johnson & Johnson company, accelerated assessment of the planned market authorization application for ceftobiprole in the treatment of complicated skin and soft tissue structure infections. A new drug application for ceftobiprole was submitted to the FDA earlier this month.
• Brane Discovery srl, of Milan, Italy, revealed additional details on a preclinical program in Parkinson's disease it licensed when it was recently spun out from Milan-based Nikem Research srl to take forward the latter company's proprietary drug development programs in central nervous system disease. The program in question, BND-001, targets Opioid Receptor-Like 1 (ORL-1). It originally resulted from a collaboration between Nikem and London-based GlaxoSmithKline plc. Brane said it expects the program to enter clinical development in the second half of 2008.
• Elan Corp plc, of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., said the Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA jointly will review Tysabri (natalizumab) for the treatment of Crohn's disease on July 31. The companies on Dec. 15 submitted a supplemental biologics license application as a treatment for moderately to severely active Crohn's disease. The product is a humanized monoclonal antibody believed to block entry of inflammatory immune cells into the wall of the intestine, the first potential treatment for that disease with that mechanism of action.
• ExonHit Therapeutics SA, of Paris, issued 400,000 new shares following the exercise of a tranche of the Paceo line signed between the company and Societe Generale Corporate & Investment Banking in October. The transaction raised gross proceeds of €3.4 million (US$4.6 million). Shares were priced at €8.53 each, and the issuance represents 1.5 percent of the company's share capital. ExonHit develops microarray technology aimed at analyzing alternative RNA splicing.
• Genmab A/S, of Copenhagen, Denmark, said it will become a member of the Copenhagen Stock Exchange's OMXC20 index as of June 18. That index comprises 20 of the most actively traded shares on the exchange and is revised biannually on the basis of turnover in terms of market value and liquidity on the basis of trading frequency.
• Pharmaxis, of Sydney, Australia, said the European Mutual Recognition Procedure has completed evaluating its lung function test Aridol, meaning the 13 European countries involved can issue a marketing authorization. The countries are Germany, France, the UK, Italy, the Netherlands, Belgium, Denmark, Greece, Spain, Finland, Ireland, Norway and Portugal. Aridol already is being marketed in Sweden and Australia. Aridol is administered as a dry powder in a hand-held inhaler, and doctors can use the test results to identify airway hyper-responsiveness.
• ProBioGen AG, of Berlin, agreed to license its so-called designer avian cell lines to Virbac SA, of Carros, France. Specifically, Virbac will use the permanent cell lines based on duck retina AGE1.cr and somite cells AGE1.cs as the production platform to develop biologicals. Financial terms were not disclosed.
• Qiagen NV, of Venlo, the Netherlands, entered a license and marketing agreement for the exclusive distribution of room temperature DNA storage technology belonging to Biomatrica Inc., of San Diego, for biological sample storage and sample management systems. In addition, during the course of the partnership, Biomatrica's SampleMatrix technology and Qiagen's rights are expected to be expanded for uses including the stabilization, shipping and storage of DNA molecules in blood and buccal swab samples for subsequent purification of the stabilized DNA for any kind of downstream application. Financial terms were not disclosed. In other news, Qiagen has purchased Digene Corp., of Gaithersburg, Md., in a $1.6 billion cash and stock deal that will result in Digene's merger into a subsidiary of Qiagen. The agreement, already approved by the boards of directors of each company, will be effected as an exchange offer. Digene shareholders may elect to receive for each Digene share either $61.25 in cash or 3.545 shares of QIAGEN stock, subject to pro-ration so that the total consideration issued for Digene stock is 55 percent cash and 45 percent Qiagen stock. The $61.25 per share is a 37 percent premium on the companies' closing stock prices on June 1. The companies expect that the stock portion of the consideration will be tax-free to Digene shareholders and Qiagen shareholders will own approximately 78 percent of the combined company on a fully diluted basis, and Digene shareholders will own approximately 22 percent. Qiagen said it expects the deal will contribute revenues of about $58 million to $60 million in the fourth quarter 2007 and approximately $260 to $270 million for the full year of 2008. Excluding one-time charges, integration and restructuring costs and amortization, the acquisition is expected to dilute Qiagen's adjusted EPS by 3 cents to 4 cents in the fourth quarter 2007. The transaction is expected to be accretive to Qiagen's adjusted earnings per share in 2008 by 2 cents to 4 cents. The new company combines Qiagen's portfolio of sample and assay technologies, including a panel of molecular diagnostic tests, with Digene's work in HPV-targeted molecular diagnostic testing. In 2008 the combined company is expected to have more than $350 million of molecular diagnostics revenues and more than $800 million in revenues.
• S*BIO Pte. Ltd., of Singapore, entered a two-year research partnership with National University Hospital-National University of Singapore Tissue Repository. The university will conduct biomarker research and evaluate tumor responsiveness to S*BIO's anticancer compounds. Terms were not disclosed.
• Sloning Biotechnology, of Puchheim, Germany, and Microsynth AG, of Balgach, Switzerland, signed a distribution partnership for Microsynth to exclusively market and sell Sloning's gene synthesis service, Slonomics, and the product family of mutant libraries, Slonomax, in Switzerland. Financial terms were not disclosed.
• Tissera Inc., of Herzliya, Israel, extended an agreement with Yeda, the technology transfer arm of the Weizmann Institute of Science in Rehovot, Israel. The institute will perform research and development activities for Tissera through April 9, 2008. The main objective for the additional research period is to further advance ongoing preclinical studies being performed on primate models of Type I diabetes mellitus, as a preparation for the initiation of human clinical studies in diabetic patients.
• Vectura Group plc, of Chippenham, UK, announced positive results in a Phase IIa proof-of-concept clinical study for VR776, for the treatment of premature ejaculation (PE). VR776 is a proprietary formulation of an unnamed centrally acting drug, delivered by oral inhalation using the Vectura's Aspirair dry powder inhaler. The active component has been approved worldwide for treatment of other indications but has never been licensed for PE. Currently no product is approved in either the U.S. or Europe for PE. It is Vectura's intention to out-license VR776.