• A-Bio Pharma Pte. Ltd., of Singapore, and Artisan Pharma Inc., of Waltham, Mass., finalized a mutually exclusive manufacturing relationship on the process development, scale-up and manufacture of ART-123, a recombinant protein for the treatment of disseminated intravascular coagulation in sepsis. A-Bio will undertake the various development and validation activities necessary to ensure further clinical development and commercial supply of ART-123 for Artisan. In return, Artisan will enter into a preferential and long-term supply agreement with A-Bio. Specific terms of the relationship were not disclosed. ART-123 is a recombinant, soluble thrombomodulin. A regulatory submission for approval of ART-123 in the treatment of DIC has been filed in Japan, while Artisan has initiated an 800-patient Phase IIb trial.

• Amarin Corp. plc, of London, reported preclinical results demonstrating that its ultra-pure eicosapentanoic acid (EPA) attenuates the age-related and beta amyloid-induced impairment of long-term potentiation, a phenomenon considered a marker of neural process integrity for memory and cognition. The study confirmed that EPA reduced concentrations of the pro-inflammatory interleukin 1-beta in rats, and also showed phosphorylation of the stress-activated protein kinase, c-jun N-terminal kinase. Those data were published in the Journal of Neurochemistry. Amarin is developing EPA for age-associated memory impairment and cognition and anticipates beginning a clinical program by the end of this year.

• Amura Holdings Ltd., of Cambridge, UK, said preclinical study results showed that oral administration of the firm's cathepsin K inhibitor compounds resulted in sustained and potent reduction of serum bone turnover biomarkers, which clinically correlates with a significant reduction in fracture rates. Cathepsin K, a member of a large family of cysteine peptidases, is an enzyme that breaks down the collagen bone matrix as part of a normal biological process.

• Biofrontera AG, of Leverkusen, Germany, raised €3.1 million (US$4.4 million) by issuing 220,582 new shares, priced at €15 each. The transaction arose from an incompleted share option the company originally issued to investors who participated in a private placement on Oct. 24, 2006. Biofrontera gained €14 per share in the transaction, while the remainder went to the financial institution that held the share option.

• Biofusion plc, of Sheffield, UK, said it signed an agreement with Finance Wales, which funds start-up companies in Wales, to co-invest in companies spun out of Cardiff University under Biofusion's technology commercialization deal with the university. At the same time, Biofusion announced it has invested a further £200,000 (US$404,000) into Abcellute Ltd., of Cardiff, Wales, a specialist in cell preservation technologies, increasing its holding to 34 percent, while Finance Wales co-invested £200,000. Abcellute has developed an advanced cell preservation matrix that keeps cells fresh for up to seven days. The money will provide development capital for new and existing contract work for the pharmaceutical industry and fund R&D into therapeutic applications of the technology.

• BTG plc, of London, said its licensee, Genzyme Corp., of Cambridge, Mass., received FDA approval to market Campath (alemtuzumab) as a first-line treatment for B-cell chronic lymphocytic leukaemia (CLL). The product previously was approved only for third-line use in CLL. BTG said the approval should increase the company's product sales and royalties.

• Cancer Research UK, of London, said it funded a record £315 million (US$637.7 million) of research last year, almost doubling the amount spent when the charity was formed five years ago, and a 26 percent increase on 2005. Cancer Research UK is the largest single independent funder of cancer research in Europe. It funds more than 4,250 research scientists, doctors and nurses throughout the UK. The charity aims to increase its R&D spending to £400 million by 2010.

• Cellectis SA, of Paris, announced that the Institut Gustave Roussy cancer center in Villejuif succeeded in inducing the correction of a mutation in a cell line isolated from a xeroderma pigmentosum (XP) patient by means of meganuclease-induced gene correction. XP is a severe genetic disease carrying a very high predisposition to skin cancers caused by severe burns when patients are exposed to UV light. Cellectis had supplied two meganuclease-cleaving sequences on the XPC gene to the IGR laboratory to assay their therapeutic potential. While describing the results as preliminary, since the efficacy and specificity of the meganuclease have to be further investigated, Cellectis said that, on the basis of molecular characterization, there was sufficient proof that the gene correction occurred by an homologous gene-targeting process. The company maintained that meganuclease-induced gene correction of inherited monogenic diseases appears to be a viable alternative to traditional gene therapy techniques based on viral vector-mediated gene transfer. Further studies are be conducted by the same laboratory, the ultimate goal being to graft corrected versions of XP patient's own cells.

• EpiStem Ltd., of Manchester, UK, completed the first year of mucositis efficacy-testing services for potential biodefense drugs, and plans to embark on a drug-screening program over the coming year. Work is being done under a U.S. National Institutes of Health program, Medical Countermeasures against Radiological and Nuclear Threats, to develop treatments for radiation sickness following a nuclear attack.

• Evogene Ltd., of Rehovot, Israel, signed a collaboration with Orfuel Inc., a U.S. subsidiary of Yavne, Israel-based Ormat Industries Ltd., in the field of alternative energy and biofuels. The partnership is aimed at providing substantially improved feedstock sources for biodiesel production. The companies will work to develop nonedible plants displaying improved oil yield and the capability to be grown in non-arable lands. Evogene will use its advanced gene and molecular marker discovery capabilities in the development of enhanced crops to be evaluated in field trials by Orfuel. Upon completion of studies, the companies plan to establish a joint venture to commercialize the developed plants.

• Lytix Biopharma, of Tromso, Norway, said preclinical studies showed its lead ultra-broad spectrum antimicrobial compound was effective against Gram-positive bacteria. Complete eradication of the test organism was obtained within 24 hours. Additional data showed it had broad efficacy, including Gram-negative Pseudomonas species as well as yeasts and fungi. Lytix expects to submit an investigational new drug application in early 2009.

• Medivir AB, of Stockholm, Sweden, presented data demonstrating MIV-701 significantly reduced osteoclast cell activity via inhibition of the enzyme cathepsin K. Results were from a preclinical osteoporosis model. The product is in Phase I trials. Data were presented at the American Society for Bone and Mineral Research meeting in Honolulu.

• MolMed SpA, of Milan, Italy, said it would publish preclinical data on the activity of its therapeutic vaccine for treating melanoma, M3TK, in a murine model. A paper titled "Lymphocytes genetically modified to express tumor antigens target DCs (dendritic cells) in vivo and induce antitumor activity" is due to appear in the Oct. 1 issue of the Journal of Clinical Investigation. M3TK, which comprises a patient's own T-cells genetically engineered ex vivo to express the tumor antigen MAGE-3, is undergoing a Phase I/II clinical trial in metastatic melanoma at two centers in Milan.

• MorphoSys AG, of Martinsried, Germany, said a HuCAL Gold-derived fully human antibody against an undisclosed target molecule in the therapeutic area of oncology has been advanced to the Phase I trial stage. The investigational new drug application filing, resulting from MorphoSys' collaboration with Novartis AG, of Basel, Switzerland, triggered an undisclosed milestone payment to MorphoSys. In May 2004, Novartis and MorphoSys signed a wide-ranging strategic antibody alliance to jointly develop new antibody-based therapeutics to treat a range of illnesses, and they expanded the deal in June 2006. The collaboration is scheduled to continue through May 2011.

• Nitec Pharma AG, of Basel, Switzerland, said the FDA accepted an investigational new drug application for Lodotra, a rheumatoid arthritis drug that is the subject of a marketing authorization application in the European Union. Lodotra is a night-time release formulation of the corticosteroid prednisone, which is based on based on GeoClock delivery technology from London-based SkyePharma plc.

• Phytopharm plc, of Godmanchester, UK, said it has reached the third stage of its collaboration with the consumer goods company Unilever plc to develop Hoodia extract as a functional food for weight loss. The partners have now on supply chain expansion and further safety studies, which will lead to studies to evaluate reductions in calorie intake as part of a weight management program in the general population. Stage II activities included successful progression of clinical safety trials, manufacturing and plant cultivation. Phytopharm licensed global rights for the extract of Hoodia, a plant indigenous to South Africa, from the South African Council for Scientific and Industrial Research in 1997, and also has advanced development of the product as a licensed drug.

• Proteome Sciences plc, of Cobham, UK, has sold its 43 percent holding in Intronn Inc., in an all-share deal with privately-held VIRxSYS Corp., of Gaithersburg, Md. The nominal value of the deal was not disclosed. VIRxSYS was founded in 1998 to develop gene therapies for HIV and genetic disorders using a lentiviral vector delivery platform. Its lead product VRX496, a CD4 T cell treatment against HIV, is in Phase II trials. Intronn brings in preclinical programs in hemophilia and dyslipidemia based on its SMaRT technology which uses mRNA to insert new sequences into a gene, to repair mutations or alter gene expression.

• Summit Corp. plc, of Oxford, UK, said safety pharmacology data generated by its zebrafish technology platform was presented at the 7th Annual Meeting of the Safety Pharmacology Society held in Edinburgh, UK, last week. The zebrafish data presented at the conference included positive results from several studies illustrating how zebrafish can be used to assess the safety of drug candidates, including the screening of known drugs in a range of organs that are conserved between zebrafish and humans, such as the heart, eye and gut.

• Tibotec Pharmaceuticals Ltd., a, Cork, Ireland, subsidiary of Johnson & Johnson, said the FDA accepted for priority review its new drug application for TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor being developed for use in combination HIV therapies. The Prescription Drug User Fee Act goal date for the NDA is Jan. 18.

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