• Ardana plc, of Edinburgh, UK, had a pre-investigational new drug application meeting with the FDA to discuss the development plan for its gonadatrophin-releasing hormone antagonist Teverelix LA in the treatment of prostate cancer, at which the FDA agreed serum testosterone levels can serve as a reliable surrogate marker of efficacy.

• Arrow Therapeutics Ltd., of London, UK, obtained clearance for its first investigational new drug application submitted to the FDA, allowing it to extend the Phase IIa trial of A-60444 for the treatment of respiratory syncytial virus (RSV) into centers in the U.S. The trial, being conducted in the UK and Australia, involves adult patients infected with RSV after bone marrow transplantation.

• Bayer Healthcare AG, of Wuppertal, Germany, and InfoSense Ltd., of London, agreed that Bayer will use InfoSense's computer technology to process its data and applications to identify and optimize potential drug leads. Financial terms were not disclosed.

• BioAlliance Pharma SA, of Paris, obtained approval from the FDA for its investigational new drug application to conduct a Phase III trial in the U.S. of its antifungal agent, miconazole Lauriad. The once-daily, extended-release, 50-mg bioadhesive buccal tablet is being developed as a first-line local treatment for oropharyngeal candidiasis, an oral fungus that occurs frequently in immuno-compromised people. The trial is to be carried out on HIV-positive patients and BioAlliance plans to initiate it in the fourth quarter.

• BioSyntech Inc., of Laval, Quebec, closed its private placement of 7.5 million shares at a price of 80 cents per share by Nicholas Piramal India Ltd., of Mumbai, India. The $6 million financing is expected to provide funds for the company to reach its 2006 clinical milestones for BST-CarGel, BST-DermOn and BST-InPod. As part of the arrangement, NPIL acquired exclusive rights for marketing BioSyntech's products in India and surrounding areas, and gained the right to appoint its chief scientific officer, Somesh Sharma, to BioSyntech's board.

• Biotage AB, of Uppsala, Sweden, is seeking about SEK48.3 million (US$6.4 million) via a preferential rights issue directed at its shareholders. The company priced the offering of about 8 million new shares at SEK6 per share. The subscription period runs from Nov. 3 through Nov. 23.

• BioVisioN AG, of Hanover, Germany, signed an agreement with Abbott Laboratories, of Abbott Park, Ill., to collaborate on the discovery of biomarkers for lung cancer. BioVisioN will analyze biological samples provided by Abbott to discover tumor biomarkers. Financial terms were not disclosed.

• CellCentric, of Cambridge, UK, received new funding of £150,000 (US$276,569) from the National Endowment for Science, Technology and the Arts. The investment will be used to increase the company's discovery capacity for epigenetic-related cancer targets and therapeutics.

• Crucell NV, of Leiden, the Netherlands, and Aeras Global TB Vaccine Foundation in Bethesda, Md., initiated a series of clinical studies for their AdVac-based tuberculosis vaccine. The studies, which follow promising results for the vaccine obtained in animal studies, are set to start in Europe, the U.S. and Africa during the second quarter of 2006. AdVac is a vaccine technology developed by Crucell, and is designed to insert genetic material through vectors.

• Evolutec Group plc, of Reading, UK, said its complement inhibitor rEV576 was effective in treating myasthenia gravis in an animal model. One dose of the compound prevented paralysis and weight loss completely for five days. The company said that suggests rEV576 might have potential in both acute conditions such as myocardial infarction and cardio-pulmonary bypass, and in chronic autoimmune conditions such as rheumatoid arthritis.

• Gentium SpA, of Villa Guardia, Italy, will start a Phase III trial for Defibrotide for the treatment of hepatic veno-occlusive disease, a life-threatening condition in which some of the veins in the liver are blocked as a result of toxic cancer treatments. Representatives of the company met with FDA officials, and the FDA encouraged Gentium to conduct further studies of the treatment. Defibrotide has been granted orphan drug status for the treatment of severe hepatic veno-occlusive disease and fast tracked for treatment of recipients of stem cell transplants.

• Innocoll Inc., of Ashburn, Va., said its wholly owned subsidiary, Innocoll Technologies, entered an agreement with Medexis SA, of Athens, Greece, part of the Gerolymatos group of companies, for the development of a wound-healing product based on Innocoll's CollaRx membrane technology. Under the terms, Medexis will fund the cost of development and be responsible for regulatory applications. Financial details were not disclosed.

• Ipsogen SAS, of Marseille, France, and Genaissance Pharmaceuticals Inc., of New Haven, Conn., said they have signed agreements with two global pharmaceutical companies to focus on identifying biomarkers that might drive the response to cancer drugs. Ipsogen will collect samples from clinical trials and will perform sample processing and pathology analysis, while Genaissance will perform genotyping and data analysis.

• MorphoSys AG, of Martinsried, Germany, and Shionogi & Co. Ltd., of Osaka, Japan, signed a three-year agreement on the use of MorphoSys' HuCAL technology. MorphoSys grants Shionogi access to its HuCAL GOLD antibody library for drug discovery, in exchange for an up-front payment an annual user fees during the span of the agreement.

• Nuevolution A/S, of Copenhagen, Denmark, said Knud Aunstrup is stepping down as CEO, and he will be replaced by Alex Haahr Gouliaey. Nuevolution is a drug discovery firm that uses its Chemetics technology to generate small-molecule drug leads.

• Peptech Ltd., of Sydney, Australia, signed an agreement with a biopharmaceuticals manufacturer to manufacture its anti-TNF domain antibody-based therapeutic for use in humans and in non-human preclinical studies. Peptech previously reported results of a preclinical study, in which the compound recorded potency levels about three times higher than a leading blockbuster anti-TNF drug against rheumatoid arthritis.

• Plethora Solutions Holding plc, of London, said it completed enrollment for the Phase II study of PSD502 for the treatment of premature ejaculation. The double-blind, placebo-controlled trial is being conducted at eight centers in Europe to investigate the effect on ejaculation latency time and subject/partner satisfaction following local application of PSD502, a proprietary formulation of the two marketed drugs lidocaine and prilocaine. The results are due later in the year.

• Prima Biomed Ltd., of Melbourne, Australia, agreed to allow its subsidiary, Arthron Pty. Ltd., to nonexclusively license use of its Fc receptor technology to Monrovia, Calif.-based Xencor Inc. for up to two years of research. Terms call for Arthron to receive an up-front fee, and a subsequent license fee. In addition, Xencor has the option to receive a nonexclusive license to the technology for the development and commercialization of products arising from the research program, and would pay Arthron an additional license fee, as well as milestones and royalties on any approved products.

• Sangamo BioSciences Inc., of Richmond, Calif., agreed to provide Novo Nordisk A/S, of Bagsvaerd, Denmark, with access to its zinc finger DNA-binding protein (ZFP) technology to use in the field of enhanced protein production. ZFPs are the dominant class of naturally occurring transcription factors in organisms from yeast to humans.

• SiBiono GeneTech Co. Ltd., of Shenzhen, China, said a report in the September 2005 issue of Human Gene Therapy described the history of Gendicine, a recombinant adenovirus encoding p53 tumor-suppressor gene that has been approved to treat head and neck squamous-cell carcinoma and marked the first commercially approved gene therapy product. The report describes the development and launch of Gendicine and provides a summary of clinical data supporting the product, which previously was published only in Chinese literature.

• Solbec Pharmaceuticals Ltd., of Perth, Australia, said findings from its Phase I trail of Coramsine (SBP002) in the treatment of solid tumors showed that the primary endpoint of safety and tolerability was achieved, and that Coramsine was safe at a dose of 1 mg/kg/day infused over two hours, daily for five days, every two weeks. Reports also indicated that the drug met secondary endpoints by showing a potential therapeutic benefit in patients with advanced cancer.

• SpinX Technologies, of Geneva, secured €10 million (US$12.5 million) in a Series B financing to support its "programmable microfluidics" platform to perform biological assays. The round was led by Bio Fund Management, with participation from seed and Series A investors Index Ventures, Auriga Partners, DFJ ePlanet Ventures and the CERN Pension Fund. Seppo Makinen, of Bio Fund Management, and Phillippe Peltier, of Auriga Partners, joined the company's board.

• Stem Cell Sciences, of Edinburgh, Scotland, formed a major licensing deal with Deltagen Inc., of Redwood City, Calif., for use of SCS's internal ribosome entry site technology. In addition to an up-front license fee of $1.2 million, the agreement includes royalties based on revenues generated by Deltagen. As part of the deal, SCS will receive genetically engineered mice from Deltagen.

• TNO Pharma, of Leiden, the Netherlands, and Mitsubishi Pharma Corp., of Tokyo, entered a collaboration in which TNO will combine its expertise in siRNA-based, knockdown technology in disease models to further characterize a set of Mitsubishi's disease targets. Financial terms were not disclosed.

• Vernalis plc, of London, said patient enrollment for its confirmatory Phase III efficacy study of frovatriptan for intermittent, short-term prevention of menstrually related migraine has been completed. Top-line data from the trial, and the filing of a supplemental new drug application, are scheduled for the first half of 2006.

• Xigen SA, of Lausanne, Switzerland, closed its Series A round, raising CHF26 million (US$21 million). The financing was led by Geneva-based Tilocor Life Sciences, Toronto-based Venture Incubator and Initiative Capital. Funds will be used to advance Xigen's lead product, XG-102, into the clinic next year for the treatment of stroke. XG-102 is a neuroprotectant designed to act by intracellular inhibition of JNK kinase. The product was developed at the University Hospital of Lausanne, which spun out Xigen in 2002.

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