• Amarin Corp. plc, of London, successfully completed a preclinical proof-of-concept study using a nasal formulation of lorazepam. The preclinical study evaluated the extent of absorption of lorazepam after nasal administration and the pharmacokinetics of the formulation. Amarin now is working with a subsidiary of Elan Corp. plc, of Dublin, Ireland, to prepare the nasal formulation for human pharmacokinetic trials.

• Anadis Ltd., of Melbourne, Australia, reported positive results for its milk-derived anti-flu virus antibodies in several animal trials with mice. The antibody significantly decreased disease mortality and significantly interrupted the disease process. The antibody preparation improved the survival rate of infected mice exposed to lethal flu from 0 percent in nontreated mice to up to 60 percent in treated mice. Other trials showed that the disease progress could be delayed for days with a single application. Human trials are expected within 18 months.

• Artes Biotechnology GmbH, of Langenfeld, Germany, and Rhein Minapharm Biogenetics, a subsidiary of Cairo, Egypt-based Minapharm SAE, started a collaboration to develop three therapeutic proteins. Under the terms, Artes will use its Hansenula technology platform and know-how for the generation of cell line production, analytical assay development and lab-scale fermentation, and granted Minapharm a commercial license option to apply its technologies to the manufacturing and marketing of those proteins. Artes also will handle the 100 L-scale production of a Minapharm protein based on an existing process using E. coli. Minapharm will carry out the process research and development, production and commercialization. Financial terms were not disclosed.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said its ceftobiprole was assigned a review by the FDA's Anti-Infective Drug Advisory Committee for Feb. 28. The company previously submitted a new drug application for ceftobiprole, a broad-spectrum cephalosporin, in complicated skin and skin structure infections, including diabetic foot infections. Ceftobiprole is partnered with Johnson & Johnson Pharmaceuticals Research and Development LLC, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson.

• BioAlliance Pharma SA, of Paris, obtained marketing approval for Loramyc in the UK and Denmark following the European mutual recognition procedure that ended in December. Securing marketing authorization in the UK brings BioAlliance a milestone payment of €2.5 million (US$3.71 million) from its partner Spepharm Holding BV, of Amsterdam, the Netherlands, with which it signed an agreement in March 2007 for the creation of a joint venture called SpeBio JV to distribute Loramyc in European countries other than France. Loramyc, BioAlliance's 50-mg, once-a-day topical formulation of miconazole for the treatment of oropharyngeal candidiasis in immunodepressed patients, is being launched in France.

• BT Pharma SA, of Toulouse, France, gained a new patent through its exclusive license with the Institut Pasteur, covering the adenylate cyclase vector technology. That patent claims a combination cancer treatment, which associates a chemotherapeutic agent with an immunotherapeutic agent, and is designed to result in an improved specific immune response against malignant tissues. BT previously licensed from the institute rights to a patent for an adenylate cyclase carrying tumor-derived antigenic peptides.

• Caprotec Bioanalytics GmbH, of Berlin, received €6 million (US$8.8 million) in two rounds of financing from Creathor Venture, IBB Beteiligungsgesellschaft, ERP Startfonds and private investors for further development and marketing of the company's CCMS platform technology for analyzing complex protein mixtures. Caprotec's CCMS (Capture Mass Spectrometry) technology is designed to isolate proteins directly and selectively from a complex cellular environment, and also can be applied both in water-soluble and membrane protein mixtures, for investigating the interactions of small molecules with the proteome.

• Crucell NV, of Leiden, the Netherlands, signed a nonexclusive license granting Seoul, South Korea-based ISU Abxis rights to its STAR research technology. The deal covers both a research evaluation of STAR for the production of recombinant proteins and an option for a commercial license. Financial terms were not disclosed.

• CSL Ltd., of Melbourne, Australia, hired contract manufacturing firm Celltrion Inc., of Incheon, South Korea, to supply the monoclonal antibody CSL 360, which is undergoing a Phase I trial for acute myeloid leukemia.

• ExonHit Therapeutics SA, of Paris, amended its cancer diagnostics partnership with bioMerieux SA, of Marcy l'Etoile, France, which gives ExonHit commercial rights to diagnostic kit development through the alliance and allows bioMerieux greater flexibility to start new research and development projects in that field. The collaboration, initiated in October 2005, is based on ExonHit's gene expression analysis expertise and bioMerieux's know-how in the field of in vitro diagnostics. The goal is to develop DNA microarrays that can detect cancer makers in blood samples. Three programs are under way: one in breast cancer, one in colorectal cancer and one targeting prostate cancer. Financial terms of the deal were not disclosed.

• ImmuPharma plc, of London, said it gained rights for the worldwide development and commercialization of IPP-204106, a cancer drug candidate believed to act with a dual mechanism to prevent both angiogenesis and proliferation. The drug, a nucleolin antagonist, emerged from the company's ongoing research collaboration with the Centre National de la Recherche Scientifique, France's scientific research institution. ImmuPharma plans to complete the formal preclinical development this year, with a Phase I trial expected to begin by year-end.

• Ipsen SA, of Paris, and the Salk Institute for Biological Studies said they will sign a memorandum of understanding creating the Ipsen Life Sciences Program at the institute. The goal of the partnership is to advance knowledge of proliferative and degenerative diseases through fundamental and applied biology research. The program will, for up to five years, sponsor three categories of research programs through targeted, core and innovation grants. Ipsen will provide funding for targeted research programs at the institute, with a particular emphasis on novel therapeutic concepts for the treatment of pituitary adenomas. Core grants will support basic research on the role of chronic inflammation to malignant diseases such as cancer, loss of cognitive functions, movement disorders and metabolic syndromes. Financial terms were not disclosed.

• Living Cell Technologies Ltd., of Melbourne, Australia, said Palmert Members Ltd., a British Virgin Island company, will purchase 24.1 million shares of LCT at A29 cents (US25 cents) each for an aggregate purchase price of $6 million. In that arrangement, Palmert will make the investment by exercising an option that was granted to NaviGroup Management Ltd., which allows the holder to purchase up to $6 million in shares at 80 percent of the 30-day average closing price. That investment brings the total to A$14 million raised by LCT and is expected to support Phase I/IIa trials of DiabeCell, as well as expansion of infrastructure required for clinical trials.

• MorphoSys AG, of Martinsried, Germany, said data published in the Journal of Virology identified a new epitope on the HIV-Protein gp41 that is capable of neutralizing various HIV strains. The research was conducted by NIH scientists using MorphoSys' HuCAL technologies.

• OncoMethylome Sciences SA, of Liege, Belgium, and Epigenomics AG, of Berlin, entered a broad technology licensing agreement under which OncoMethylome obtained worldwide nonexclusive rights to several of Epigenomics' core technologies, including its MethyLight portfolio for the sensitive and quantitative detection of DNA methylation for in vitro diagnostic product development and commercialization. OncoMethylome also gained rights to HeavyMethyl technology, plus certain microarray-based technologies for DNA methylation analysis. In return, Epigenomics will receive an up-front payment and is eligible for royalties to be paid on any eventual commercial exploitation of the technologies by OncoMethylome or its partners. Both companies continue to develop their own products independently, and biomarker licenses have not been granted. Further terms were not disclosed.

• Onyvax Ltd., of London, said it was awarded a £1.1 million (US$2.2 million) grant by the UK Technology Strategy Board toward a £1.8 million project to develop next-generation cell-based cancer vaccines. The project will combine microscale process engineering technology with advanced analytical and bioinformatics-based methods to predict and optimize cell line performance in large-scale manufacturing processes. That could be used to reduce the cost and time involved in selecting and producing new cell lines for vaccines and could be applied to other areas of cell therapy, including regenerative medicine and stem cell therapy.

• Plasticell Ltd., of London, entered an agreement with Axordia Ltd., of Sheffield, UK, to exploit and market a panel of six human embryonic stem cell lines. Under the terms, Plasticell obtained a right to make and sell the hESC lines Shef 1, 2, 4, 5, 7 and 8, which were derived at the University of Sheffield. Privately held Plasticell focuses on discovering regenerative small-molecule drugs and forming alliances for high-throughput stem cell differentiation to derive cell lines and reagents. Terms of the licensing agreement were not disclosed.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, has signed a lease agreement to expand its manufacturing and research facility, providing approximately three times more space than currently in anticipation of the potential commercialization of the company's lead product candidate, prGCD, a therapeutic protein for the treatment of Gaucher disease. The lease is for 7.5 years with options to extend up to 15 additional years.

• Rosetta Genomics Ltd., of Rehovot, Israel, has signed a collaboration agreement with the Henry Ford Health System in Detroit to develop microRNA-based diagnostics and prognostics for brain cancer. The parties will conduct a genomewide molecular analysis of human brain cancer tumors to identify unique microRNA biomarkers that have diagnostic and prognostic potential. When the analysis is completed, Rosetta will perform a microRNA analysis from Formalin Fixed Paraffin Embedded samples received from Henry Ford Hospital.

• Sysmex Corp., of Kobe, Japan, and bioMérieux, of Marcy L'etoile, France, said they have signed an agreement under which Sysmex will take a 34 percent equity stake in bioMérieux's Japanese subsidiary to form a new company called Sysmex bioMérieux Co. Ltd. The new firm will promote and commercialize the entire bioMérieux product range in Japan starting April 1, the companies said. The joint venture will manage the regulatory filing and marketing activities of bioMérieux product ranges in Japan, the firms said, adding that the sales and customer service activities will be contracted to Sysmex.

• Tissera Inc., of Herzliya, Israel, said diabetic model experiments of pancreatic xenotransplantation successfully weaned diabetic nonhuman primates from the use of exogenous insulin. After pig embryonic pancreatic tissue was transplanted into the diabetic primates, a reduction of insulin amounts required for maintenance of near-normal blood sugar levels was observed, with less than 10 percent of starting daily insulin dose by month four after transplantation and reaching complete exogenous insulin independence at about five months, meaning that endogenous insulin production had taken over control of blood sugar levels. Further studies are under way.

• Wanxing Bio-pharmaceuticals Co. Ltd., of Shanghai, China, said its subsidiary Sinobiomed Inc. has been granted government funding of RMB9 million (US$1.24 million) to continue the clinical trial of its recombinant malaria vaccine and advance its development with partner Second Military Medical University. The funding is the largest the Chinese government has ever granted to a biopharmaceutical company. The grant from China's Ministry of Science and Technology is part of the key "863 Program" to support technology development as part of the government's 11th five-year plan.

• Yissum Ltd., of Jerusalem, the technology transfer arm of the Hebrew University, licensed an oral, small molecule for conditions such as neurodegenerative diseases to Eucalyptus Ltd. The molecule, AD4 (N-acetylcysteine amide), is an antioxidant designed to overcome the blood-brain barrier. Under the terms, Yissum, together with the technology transfer arms of Tel Aviv University and Clalit Health Services, will receive up-front payment, plus milestones and royalties. Specific terms were not disclosed.

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