• Anavex Life Sciences Corp., of Geneva, said in vivo preclinical data showed that ANAVEX 1-41 and ANAVEX 2-73, muscarinic ligands with a high affinity for the sigma-1 receptor, suggest a possibly neuroprotective and anti-amnesiac efficacy in Alzheimer's disease. In mouse models, both compounds reversed the learning deficits induced by the AB25-35 peptide in a dose-dependent manner and was found to be effective in both short-term and long-term memory tests. Data were presented at the Neurosciences meeting in Montpellier, France.
• 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 clinical study of Trinam, its gene therapy to prevent hemodialysis 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 begin in the second half of the year. Ark's CEO, Nigel Parker, said, "The rapid granting of this approval without the need for a public hearing illustrates just how far gene-based medicine has advanced in the last year or two."
• Axxam SpA, of Milan, Italy, and PerkinElmer Inc., of Boston, entered a deal under which PE will become the exclusive provider of Axxam's Photina photoprotein technology to the drug discovery market. The technology is a luminescent cell-based assay platform optimized for screening drug discovery targets, including G protein- coupled receptors and ion channels. Terms also provide for a formal research and development program for additional Photina GPCR and ion channel cell lines for use in high-throughput screening and compound profiling. Axxam retains rights to use the technology for its discovery services to third parties. Terms of the deal were not disclosed.
• Debiopharm Group, of Lausanne, Switzerland, said its three-month, sustained-release formulation of Salvacyl/Moapar completed the European mutual recognition procedure in Germany, Belgium, Denmark, Finland, France, Norway, the Netherlands and the UK. Last year, the gonadotropin-releasing hormone agonist analogue for sexual deviations was approved in Sweden, which was the reference member state. The company is seeking a commercial partner for the product's sales and marketing.
• Novagali Pharma SA, of Evry, France, said Vekacia, a cyclosporine A drug, was granted orphan drug designation by the FDA for vernal keratoconjunctivitis, a rare and severe form of chronic allergic conjunctivitis affecting mostly children and young adults. That designation would provide Novagali with regulatory assistance for Vekacia and provide the product seven years of marketing exclusivity upon FDA approval. The product previously received orphan status in the European Union, which would provide 10 years of marketing exclusivity upon marketing approval.
• SinoBiomed Inc., of Shanghai, China, said its subsidiary Shanghai Wanxing Bio-pharmaceuticals Co. Ltd. has signed a letter of intent to acquire pharmaceutical distribution company Suzhou Baoi Medical Development Co., of Suzhou, China. Suzhou had 2006 revenues of $21 million and will be acquired through an equity transfer of not less than 80 percent. The transfer price initially is set at two times Suzhou's authorized capital of $2.5 million.
• ThromboGenics NV, of Leuven, Belgium, has decided to absorb Thromb-X NV, its wholly owned subsidiary. There will be no issuance of new shares or cash payment upon completion of the transaction, which is expected to be approved at the next Extraordinary General Assembly in July. The decision will allow ThomboGenics to streamline its corporate structure, consolidating its Belgian activities. There will be no impact on the company operations or financials.
• TMO Renewables Ltd., of Surrey, UK, licensed the ERGO bioinformatics software developed and maintained by Chicago-based Integrated Genomics Inc. for gene annotation, metabolic reconstruction and enzyme data mining, as well as for comparative genomics. The ERGO platform is expected to allow TMO to further understand and exploit its thermophilic strains to deliver green biofuels. Terms of the deal were not disclosed.
• 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 the product.