• Alimentary Health, of Cork, Ireland, said two studies demonstrated the anti-inflammatory activity of a natural probiotic bacterial strain of human origin, Bifantis (Bifidobacterium infantis 35624), in models of arthritis and salmonella infection. In one of the studies, four bacterial strains were fed to mice and researchers determined that only Bifantis delayed the onset of artificially induced arthritis and resulted in less severe arthritic symptoms. In the second study, mice fed Bifantis and then exposed to salmonella showed dramatically increased numbers of certain immune cells that control the immune system's response to harmful pathogens. Bifantis also increased the numbers of T- regulatory cells in the body, in effect limiting the concentrations of certain signals essential to inflammation, such as cytokines. Data from these studies were presented at the 38th annual Digestive Disease Week conference in Washington DC.

• Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, is planning an IPO on the Euronext exchange in Amsterdam. The company is seeking new cash to fund development of its pipeline of gene therapies for orphan indications and to build a sales force.

• Ardana plc, of Edinburgh, UK, was granted orphan drug status for ARD-07, an oral growth hormone secretagogue (GHS), which Ardana is developing as a diagnostic for growth hormone deficiency in adults. GHS is an oral synthetic small molecule that stimulates the secretion of growth hormone in the pituitary gland and/or indirectly via stimulation of growth hormone releasing hormone (GHRH) from the hypothalamus.

• Bavarian Nordic A/S, Kvistgard, Denmark, said it is appealing a ruling by a federal district court in Delaware that dismissed its claims of conversion, unfair competition and unfair trade acts on summary judgment. The suit relates to production of the company's smallpox vaccine MVA3000. The order has no impact on the patent case pending at the U.S. International Trade Commission, which earlier this year reversed an administrative law judge's initial determination in a case in which Bavarian Nordic's patents on MVA were found to be infringed but invalid. The ITC remanded the entire case on grounds that the law judge made errors of law and fact. The patent case awaits an assignment of a new trial date.

• Biocortech, of Paris, said its EDIT CNS project aimed at discovering treatments of psychiatric disorders has been selected by Paris Biocluster "Pôle de compétitivité Medicen'"and will be financed by the French Ministry of Industry. The program will provide Biocortech with €1.9 million in non-repayable, non-dilutive grant financing over the next three years. This company is working to generate drug candidates for bipolar depression, schizophrenia as well as new chemo-informatic and ADME-tox

• Genmab A/S, of Copenhagen, Denmark, said its fully human antibody HuMax-HepC prevented Hepatitis C virus (HCV) infection in an animal model. In the pre-clinical study, mice with a compromised immune system were transplanted with human liver cells (hepatocytes) and exposed to a mixture of patient-derived HCV of different genotypes. Replication of HCV was not observed in five of six mice treated with HuMax-HepC, indicating it completely prevented HCV infection. The sixth mouse was infected with HCV, but the virus was subsequently cleared. In comparison, five of six mice that received a control antibody developed and sustained a robust HCV infection. The data were presented at the 38th annual Digestive Disease Week conference in Washington DC.

• GPC Biotech AG, of Martinsried, Germany, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the FDA's Oncology Drug Advisory Committee will review the new drug application (NDA) on July 24 for oral platinum drug satraplatin in the second-line treatment of hormone refractory prostate cancer. The NDA is based on an improvement in progression-free survival demonstrated in a Phase III trial conducted under special protocol assessment. An FDA decision is expected by Aug. 15.

• MorphoSys AG, of Martinsried, Germany, said stockholders approved a 3-for-1 stock split. Each shareholder will receive two additional shares for every outstanding share held on a given date, and trading will begin on a split-adjusted basis in July. In other news, shareholders also confirmed the appointment of Walter Blattler to its supervisory board.

• Phytopharm plc, of Godmanchester, UK, said it received UK regulatory approval for a Phase Ib healthy volunteer clinical study for Myogane, an orally active neurotrophic factor inducer being developed for amyotrophic lateral sclerosis, the most prevalent form of motor neurone disease. The healthy volunteer study utilizes a randomized, double-blind, placebo-controlled design with a new liquid formulation of Myogane. ALS patients have difficulty in swallowing and the new formulation aims to make the drug easier to administer.

• Proteome Sciences plc, of Cobham, UK, said the European Patent Office will grant a patent on its isobaric mass tags and their use as chemical reagents to label proteins. The company said that will enable it to solicit licenses and royalties from a number of companies that are using that type of mass tags currently.

• Proteros Biostructures GmbH, of Martinsried, Germany, and Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., entered an 18-month deal in the field of protein crystallography. Proteros is entitled to research funding and success payments for the generation and analyses of protein-ligand structures of hits and evolved chemical entities from BI programs. Proteros will use its Free Mounting System and Picodropper technologies in the effort. Terms were not disclosed.

• Rosetta Genomics, of Rehovot, Israel, has signed a research agreement with Columbia University Medical Center to advance its lead cancer diagnostic. The medical center will use its laboratory to perform clinical validation of the company's lead diagnostics program for Cancer of Unknown Primary (CUP). This is Rosetta Genomics' first agreement for clinical validation of one of its cancer diagnostic tests. The company is developing several microRNA-based diagnostics at its R&D facilities in Israel and the U.S. The company's CUP diagnostic, currently in the final stages of development, is designed to assist clinicians in identifying the origin of tumors which have metastasized throughout the body.

• Scil Technology GmbH, of Martinsried, Germany, gained regulatory approval to begin a Phase II clinical trial of MD05 as a surgical treatment of periodontal disease. MD05, which comprises a synthetic carrier linked to recombinant human growth and differentiation factor-5, a protein that promotes bone growth, is designed to promote tissue regeneration. Patient recruitment will commence in the coming weeks.

• Shire plc, of Basingstoke, UK, has received an approvable letter from the FDA for SPD465, an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Shire submitted a New Drug Application for SPD465 on July 21, 2006. The company said it is evaluating its options related to SPD465, a single entity formulation of mixed amphetamine salts.

• VASTox plc, of Oxford, UK, said it signed a long-term commercial collaboration with an undisclosed U.S. pharmaceutical company. The deal involves VASTox's wholly owned subsidiary, Dextra Laboratories, which specializes in carbohydrate drug discovery and development. Work will focus on a late-stage development product owned by the undisclosed company that is due to launch in 2010. Dextra will work to improve the cost efficiency of the manufacturing route. VASTox will receive development payments of $450,000, and a 5 percent annual royalty fee starting in 2009.

• Vernalis plc, of Winnersh, UK, and Servier, of Neuilly-sur-Seine, France, entered a joint, three-year oncology drug discovery collaboration. Under the terms, the companies will use Vernalis' drug discovery platform on an undisclosed target. In exchange, Vernalis will receive an up-front payment and be entitled to a share in the downstream success of the product. Specific financial terms were not disclosed. In separate news, Vernalis recently reported that another partner, Novartis SA, of Basel, Switzerland, selected a second Hsp90 compound for preclinical development using Vernalis' platform.

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