• Acambis plc,of Cambridge, UK, reached a global settlement withBavarian Nordic A/S, of Kvistgard, Denmark, regarding smallpox vaccines based on the Modified Vaccinia Ankara (MVA) virus. Bavarian Nordic will grant Acambis a license to some of its MVA patents in return for an undisclosed up-front payment, milestone payments and royalties on certain MVA products. The settlement ends all pending litigation and further appeals.

• Active Biotech AB, of Lund, Sweden, said its cancer immunotherapeutic Anyara has been granted orphan drug status by the Committee for Orphan Medicinal Products of the European Medicines Agency. The designation provides a variety of incentives, including market exclusivity for up to 10 years following approval. Anyara is one of the company's lead oncology candidate drugs and is in Phase II/III trials for the indication renal cancer.

• Ark Therapeutics Group plc, of London, said the independent data and safety monitoring board found no safety issues with the Phase III trial of its lead product, Cerepro, a gene therapy treatment for high-grade glioma, following a review of the fully recruited trial. No modifications are required either to the protocol or conduct of the trial, and the board said it should continue to run as planned. The Phase III is a standard care controlled study to assess the efficacy and safety of Cerepro in 250 patients with high-grade glioma. Patients are randomized in a 1:1 ratio either to standard care alone or to standard care plus Cerepro treatment, and patients are blinded to the point of treatment allocation.

• Can-Fite Biopharma, of Jerusalem, said pre-clinical studies showed that the excipients used in the placebo and in the CF-101 drug during the Phase IIb RA study enhanced the anti-inflammatory effect of methotrexate. The excipient is an oil mixture containing polyoxyl 45 castor oil and miglyol 812. In pre-clinical work scientists found that the excipients led to up-regulation of the two adenosine receptors, A3 and A2A, which are known to mediate the effect of MTX. Can-Fite has filed a patent application to protect the excipient activity and is considering further development of its use.

• Cobra Biomanufacturing, of Keele, UK, is going into space. The company will carry out sterility testing for the atmospheric, oceanic and planetary physics department of Oxford University as part of the ExoMars mission that is scheduled to land on Mars in 2014. ExoMars, coordinated by the European Space Agency, must comply with international standards for the cleanliness of a spacecraft travelling to a planet that may contain life, or past indicators of life. The craft will carry life-detection instrumentation constructed by the Oxford group, which Cobra will be responsible for checking for bacterial contamination.

• Corcept Therapeutics, of Menlo Park, Calif., and Xceleron, of York, UK, are combining for a human microdosing study of one of Corcept's new chemical entities, a selective GR-II antagonist, using Xceleron's Accelerator Mass Spectrometry (AMS) technology. Corcept said it has identified three distinct series of GR-II antagonists for possible development, which appear to be as potent as Corcept's lead product Corlux in blocking cortisol but which do not block the progesterone or other steroid receptors. Corcept will evaluate one of the compounds, one which develops particularly high plasma and brain concentrations in an animal model, in a human microdosing study using Xceleron's AMS technology.

• Crucell NV, of Leiden, the Netherlands, has entered into a co-exclusive license agreement with Wyeth Pharmaceuticals, of Collegeville, Pa., for PER.C6 and Advac technology. Crucell will receive an up-front payment, milestones, annual maintenance fees and royalties on net product sales. Other financial details were not disclosed. Crucell's AdVac technology is a recombinant vector technology used to develop novel adenoviral-based products. PER.C6 technology is based on a human cell line developed for the large-scale manufacture of biological products including vaccines.

• DSM Biologics, of Sittard, the Netherlands, has reached a nonexclusive research licensing agreement with LFB Biotechnologies, of Paris, allowing LFB to use its technology to develop undisclosed antibodies. No financial details were disclosed. During the research license period, they also will evaluate a joint collaboration in the field of enhancing sugar structures, described as glycosylation patterns, on recombinant antibodies using LFB's in-house developed technology.

• Eden Biodesign Ltd., of Liverpool, UK, said it was selected by the University of Birmingham in the UK to develop and produce vOX2:Fc, a therapeutic candidate for the treatment of autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. Funding for the project has been provided by the National Biomanufacturing Centre Access Fund administered by the Northwest Regional Development Agency. Eden Biodesign is the operator of the NBC facility.

• Elan Corp., of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., saw their shares fall Friday after FDA briefing documents released prior to Tuesday's joint meeting of the Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees suggested that the multiple sclerosis drug Tysabri (natalizumab) might not be effective enough against Crohn's disease to outweigh potential risks. Tysabri sales were suspended in 2005 after the drug was linked to cases of the fatal brain disease progressive multifocal leukoencephalopathy, though the drug was allowed back on the market last year in limited uses. The advisory committees will pass a recommendation onto FDA reviewers following Tuesday's meeting. Though not binding, the agency generally follows the recommendations of its advisory panels.

• Evogene Ltd., of Rehovot, Israel, and the French scientific organization CIRAD expanded their collaboration from 2004. They plan to introduce Evogene's EVO133 gene into cotton and to validate its use for drought tolerance. The EVO133 gene has been tested in three seasons of field trials in processing tomato varieties and demonstrated the potential to increase yield under normal conditions and reduce yield penalty under unfavorable conditions, Evogene said. It also is being developed in other crops with other partners.

• Galapagos, of Belgium, has received $1 million as its second milestone payment in its antibody collaboration with Novartis. The first milestone payment, which was related to intellectual property, was announced last December. Since then the collaboration was transferred to Galapagos as part of its acquisition of ProSkelia. Total milestones eventually could exceed $100 million, with undisclosed royalties payable on commercialization.

• MediGene AG, of Martinsried, Germany, said it was informed by partner CollaGenex Pharmaceuticals Inc., of Newtown, Mass., that the European marketing authorization for Oracea in rosacea has been postponed after the committee of the nine countries involved failed to reach a unanimous decision. The procedure then moves to another committee, adding about six months to the process. Marketing applications for Oracea have been submitted in Germany, the UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg and the Netherlands. MediGene acquired pan-European rights to Oracea in 2006 from CollaGenex, which gained U.S. approval for the product last year.

• NicOx SA, of Sophia-Antipolis, France, reported a sharply reduced net loss of €6.6 million for the first quarter of 2007, down from €14.7 million in the corresponding period last year. That was due to a trebling of revenues to €11.2 million from €3.7 million in the first six months of 2006 as a result of payments received from two of NicOx' partners, Merck & Co. Inc., of Whitehouse Station, N.J., (in the hypertensives field) and Pfizer Inc., of New York, (ophthalmology). Operating expenses rose to €21 million in the first half of this year from €19 million the year before, due to the development costs of NicOx' lead product, naproxcinod, a treatment of the signs and symptoms of osteoarthritis, but the program is expected to result in a significant rebound in the company's net loss in the second half of 2007. NicOx' cash and cash equivalents stood at €195.2 million as of June 30, up from €81.7 million at the end of 2006, thanks to the €120 million rights issue completed in February.

• Novogen Ltd., of Sydney, Australia, said an investigational anti-inflammatory drug developed using its phenolic technology platform produced promising results in animal studies as an arthritis control therapy. A group of eight rats given the drug in their feed showed significantly lower joint scores when compared with another group of eight rats given untreated feed. Results suggested that the drug, a FAIM (flavonoid anti-inflammatory molecule), could be efficacious in treating inflammation without the gastrointestinal side effects of nonsteroidal anti-inflammatory drugs and the cardiovascular risks associated with COX-2 inhibitors.

• Organon Bioscience NV, of Oss, the Netherlands, signed a collaboration with MRC Technology, of London, to develop a humanized antibody for the treatment of certain, unspecified, cancers. The Therapeutic Antibody Group at MRCT will use its proprietary CDR grafting technology to generate a humanized clinical candidate from a murine antibody discovered at Organon's Research Center in Cambridge, Mass. Organon will pay research and development milestones, and royalties on net sales.

• Oxford BioMedica plc, of Oxford, UK, said the independent data safety monitoring board for the Phase III study of its gene therapy, TroVax, in renal cancer has concluded that the trial should continue as planned without modification. The board reviewed safety and anticancer immune responses from the first 50 patients enrolled. The trial is a randomized, placebo-controlled, two-arm study comparing TroVax in combination with standard care to placebo with standard care, and is expected to complete in early 2009.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said warrants issued in connection with the company's recently closed entitlements offering have been approved for listing on the Nasdaq Capital Market. The warrants will begin trading today under the ticker symbol PGLAW.

• Silence Therapeutics plc, of London, appointed Jeffery Vick CEO. He has worked in the health care industry in both Europe and the U.S., and spent time as a business analyst and biotechnology venture capitalist. Silence Therapeutics is developing products based on RNA interference.

• Siemens AG, of Munich, Germany, said its Siemens Medical Solutions division received FDA clearance to begin a Phase I trial evaluating [F-18] 3'-fluoro-3'-deoxythymidine (FLT) as a biomarker of cancer cell proliferation. The trial will be conducted at Memorial Sloan-Kettering Cancer Center and will utilize positron emission tomography imaging.

• Summit Corp. plc, of Oxford, UK (formerly Vastox plc), and Evolva Biotech SA, of Basel, Switzerland, entered a three-year agreement to develop drugs for infectious diseases. The collaboration covers Summit's immunomodulator drug candidate SMT14400 (formerly VOX 14400) and backup compounds from its imino sugar library. They will work to develop clinical-stage compounds that show efficacy against viruses and bacteria relating specifically to biodefense targets such as anthrax and Ebola, and other infectious diseases such as HIV and influenza. The companies will make an initial co-investment of $1 million, and co-invest more than $10 million over the next three years on a 50:50 basis in infectious diseases. Summit has rights to SMT14400 in the areas of oncology and allergy.

• Vivalis, of Nantes, France, and MAT BioPharma, of Evry, France, said they will enter a new phase of their collaboration to produce preclinical products. The move followed promising data from the deal under which MAT is evaluating Vivalis' EBx cell lines for the production of monoclonal antibodies. The companies said they demonstrated that the glycosylation profile of a monoclonal antibody of the IgG1 subtype produced in avian EBx cells is similar to human antibodies' glycosylation profile.