• Abcellute Ltd., of Cardiff, UK, raised an additional £400,000 (US$816,717) to accelerate development of its non-freezing cell preservation technology. The techniques are intended for use in cell therapies. Working with collaborators, the company has demonstrated that freshly isolated human hepatocytes preserved in Abcellute's matrix remain viable and retain essential functions for up to seven days without freezing.

• Ablynx, of Ghent, Belgium, has extended its drug discovery and development alliance with Novartis AG, of Basel, Switzerland. The 2-year-old agreement, covering work on Ablynx's antibody-derived Nanobody therapeutic proteins for disease targets difficult to address with conventional antibodies or their fragments, will run until December 2008. The agreement gives Novartis the exclusive right to develop and commercialize the products resulting from the collaboration. Ablynx receives license fees and funding for research and development, and is eligible for milestone payments and royalties upon commercialization.

• Anavex Life Sciences Corp., of Geneva, said that data from preclinical animal studies demonstrated that ANAVEX 2-73 and its active metabolite ANAVEX 19-144 have potent anticonvulsive, antiamnesic, neuroprotective and antidepressant properties. In 90 percent to 100 percent of the treated animals vs. the control group, both ANAVEX 2-73 and ANAVEX 19-144 exhibited extremely significant anticonvulsive action by providing almost complete protection from tonic seizures, the firm said. The compounds are being explored to treat epilepsy.

• Antisoma plc, of London, said it presented positive preclinical data supporting its ongoing Phase II trial of AS1411 in acute myeloid leukaemia (AML) at the American Society of Hematology (ASH) meeting in Atlanta. Researchers from the Medical University of South Carolina showed that AS1411 killed AML cells and associated that with downregulation of the apoptosis-blocking protein Bcl-2. The target of AS1411 is nucleolin, which in AML cells acts to stabilize the messenger RNA for Bcl-2. That ensures high levels of Bcl-2 protein are maintained, placing a block on programmed cell death or apoptosis. AS1411 binds nucleolin, leading to a fall in the level of Bcl-2 protein, and thus removing the block on apoptosis. Daniel Fernandes, leader of the group behind the ASH presentation, said, "Bcl-2 is of fundamental importance to the survival and proliferation of various cancers, and it is very interesting to see the high sensitivity of AML cells to AS1411 correlated with the drug's effect on this pathway."

• BioInvent International, of Lund, Sweden, designated a new clinical candidate, BI-505, from its research program in the area of apoptosis. BI-505, which targets ICAM-1, a protein expressed heavily on tumor cells, is ready to enter preclinical development.

• Centocor Inc., of Horsham, Pa., and Janssen-Cilag International NV, of Beerse, Belgium, said regulatory applications have been submitted requesting the approval of ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor has submitted a biologics license application with the FDA and Janssen-Cilag has submitted a marketing authorization application to the European Medicines Agency. Ustekinumab is a new, human monoclonal antibody that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis. The submissions are based on a development program including data from two Phase III multicenter, randomized, double-blind, placebo-controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque-type psoriasis.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, said it has completed preparations for the U.S. Phase III program for M6G its morphine derivative, with the Phase I pharmacokinetic study showing a favorable profile of linear pharmacokinetics with minimal drug accumulation on repeat dosing. In addition, the Phase I metabolism study supported the anticipated differentiation of M6G from morphine, and the last renally impaired volunteer now has entered the Phase I renal-impairment study. All additional preclinical studies required by the FDA have been completed, and the partnering process for M6G is ongoing with CeNeS saying it expects to announce a licensing deal in 2008.

• Gentium SpA, of Villa Guardia, Italy, said, as a corollary to its Phase III trial of Defibrotide in veno-occlusive disease with multiple organ failure (severe VOD), it also initiated an expanded access program to treat severe VOD. That program is not expected to impact enrollment in the ongoing study, but the company will be able to collect additional data from the program to support its planned new drug application for Defibrotide.

• GlaxoSmithKline, of London, and Galapagos, of Mechelen, Belgium, announced a multiyear strategic alliance to develop anti-infective drug candidates. The alliance will use the natural product compound collection and chemistry capabilities of BioFocus DPI, Galapagos' services division. Galapagos will be responsible for the discovery and development of natural product small-molecule drug candidates through to clinical proof of concept, at which point GSK will have the exclusive option to license each compound for further development and commercialization on a worldwide basis. Galapagos will receive total up-front fees of up to €3.5 million (US$5 million), and could be eligible for up to €95 million in up-front fees, development and regulatory milestones payments for each product candidate. If a product is commercialized, Galapagos may receive up to €120 million for achievement of specific sales milestones. Galapagos also is eligible to receive up to double-digit royalties on worldwide sales of alliance products. This is Galapagos' first alliance outside bone and joint diseases.

• Henderson Morley plc, of Birmingham, UK, said it started preclinical toxicity, immunogenicity and dose-ranging studies on its vaccine candidate for herpes simplex virus. The studies, being carried out by a U.S.-based CRO will be completed by end of the first quarter 2008, with results due by the end of the second quarter.

• Ipsen SA, of Paris, submitted a biologics license application for Dysport for injection in cervical dystonia. The product has been granted orphan drug status and its BLA is based on data from two pivotal Phase III studies in 252 patients followed up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia. Dysport, which contains botulinum neurotoxin Type A complex as its active ingredient, currently is marketed as Reloxin in the U.S. aesthetic market.

• Janssen-Cilag, of Stockholm, Sweden, said it has submitted a marketing authorization application (MAA) for dapoxetine, a treatment for premature ejaculation in men ages 18-64. The MAA was submitted under the so-called decentralized procedure, in which Sweden will act as the reference member state and Austria, Finland, Germany, Italy, Portugal and Spain will act as the concerned member states for the application, the firm said, adding that regulatory submissions in other regions of the world are expected to follow. Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with premature ejaculation, the company said. The safety and efficacy trials showed increases in average intravaginal ejaculatory latency time and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation.

• Medgenics, of Karmiel, Israel, said that its shares have been admitted to trading on the London Stock Exchange AIM. The firm said it has raised a total of €3.27 million (US$4.83 million). The company is at the clinical trial stage of testing the safety and efficacy of its proprietary biological pump, the Biopump, and associated technologies for producing and delivering therapeutic proteins in patients.

• Neurochem Ltd., of Ecublens, Switzerland, said it has been informed that its response to the FDA July 2007 approvable letter for its application for Kiacta (eprodisate) for the treatment of Amyloid A amyloidosis, a progressive and fatal condition linked to chronic inflammatory disorders and infections and certain inherited diseases, is complete and has been granted a Class 2 review. The FDA is expected to make an approval decision by April 2, 2008, the Prescription Drug User Fee Act action date.

• Oxford BioMedica plc, of Oxford, UK, said the independent data safety monitoring board for the Phase III TRIST study of its gene therapy TroVax in renal cancer completed its second planned interim analysis and concluded that the trial should continue as planned without modification. The trial of TroVax, being developed in collaboration with Sanofi-Aventis SA, of Paris, is a randomized, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The trial started in November 2006 and to date, more than 500 patients have been randomized of a target enrollment of approximately 700 patients. More than 100 sites in the U.S., European Union and Eastern Europe are recruiting patients. The primary endpoint for the trial is overall survival in the TroVax-treated group vs. the placebo group.

• Pharmaxis, of Sydney, Australia, has established a subsidiary company based in Philadelphia to serve the North American market. The goal is to strengthen Pharmaxis' U.S. clinical and regulatory program, and prepare for the commercialization of both Aridol and Bronchitol in the U.S.

• Symphogen AS, of Copenhagen, Denmark, said that preclinical data revealed that Sym003 exhibited superior potency and efficacy in a validated animal model of syncytial virus infection. In addition, the firm said the data demonstrated enhanced antibody potency and antigen neutralization by using recombinant polyclonal antibodies, when compared with monoclonal antibodies currently marketed and in development.

• ThromboGenics, of Leuven, Belgium, confirmed that it is to move into Phase II clinical development of its TB-402 recombinant human monoclonal antibody, after promising results from Phase I trials announced Dec. 10. The product showed beneficial partial and long-acting inhibition of Factor VIII. Drug interaction studies will start in the first half of 2008 in parallel with the preparatory work for a dose-ranging clinical trial evaluating safety and efficacy to prevent deep-vein thrombosis in an orthopedic surgery setting. TB-402 is being co-developed in collaboration with BioInvent International, of Lund, Sweden.

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