• Allergy Therapeutics plc, of Worthing, UK, gave an update on the clinical hold placed on its programs by the FDA on July 11 following the report of an adverse event classified at that time by the physician involved as possibly related to the company's allergy vaccine. The company submitted a package of information to the FDA and said a recent meeting was constructive and resulted in a better mutual understanding. The FDA said it is in the process of conducting a thorough review. Allergy Therapeutics said it will make further submissions and work to lift the clinical hold.

• Amphion Innovations plc, of London, said its investee company, WellGen Inc., of North Brunswick, N.J., a nutrigenomics specialist, raised $9.5 million in an oversubscribed third round funding at $2.50 per share. Amphion now owns approximately 15.3 percent of WellGen, which is valued at $61.6 million. The money will enable Wellgen to take its anti-obesity ingredient for functional foods into human studies and conduct further studies of WG0401, a tea extract which has anti-inflammatory properties.

• Apitope Technology Ltd., of Bristol, UK, announced the completion of dosing for six secondary progressive multiple sclerosis patients in a Phase I/IIa trial of its therapeutic vaccine ATX-MS-1467 and said it was safe and well-tolerated. Although efficacy was not an endpoint, one patient with optic neuritis demonstrated a clinically significant improvement in visual acuity. The company said the early indication of efficacy suggested ATX-MS-1467 can suppress the inflammation associated with MS. Apitope intends to move the product into proof of concept trials. The company also is developing an MS diagnostic based on its proprietary technology.

• Crucell NV, of Leiden, the Netherlands, said DSM Biologics, a business unit of Crucell and DSM Pharmaceutical Products, signed a nonexclusive PER.C6 technology research licensing agreement with Brazilian-based Recepta Biopharma SA. That deal allows Recepta to use the technology to develop four antibodies it in-licensed from the Ludwig Institute for Cancer Research. Financial terms were not disclosed.

• Debiopharm Group SA, of Lausanne, Switzerland, licensed ex-Japan development and commercialization rights to cancer drug DACH-Platin Polymeric Micelle (Debio 0507/NC-4016) from Chiba, Japan-based NanoCarrier Co. Ltd. Debiopharm will provide DACH-platin starting material and pay NanoCarrier an up-front fee, milestone payments, manufacturing costs and royalties. NanoCarrier will pay Debiopharm for any data used to support registration in Japan. Separately, Debiopharm and Ipsen SA, of Paris, expanded their agreement under which Ipsen commercializes prostate cancer drug Decapeptyl (triptorelin pamoate). Ipsen licensed rights to a Phase III sustained-release formulation of Decapeptyl for a minimum of five years after the current formulations go off patent in 2010.

• Direvo Biotech AG, of Cologne, Germany, said its collaborative industrial enzyme protein engineering project with Danisco AS, of Copenhagen, Denmark, has yielded a significantly improved phytase enzyme. Phytase enzymes release phosphate from phytic acid, which is the main phosphate storage molecule in plants. The project exploited Direvo's high throughput, robotic screening and directed evolution technologies for enzyme optimization.

• Elan Pharmaceuticals Inc., of Dublin, Ireland, has licensed data analysis suite MetaCore from GenGo, of St. Joseph, Mich. MetaCore is designed for functional analysis of biological and chemistry data. Elan will use MetaCore in their neurology and autoimmune programs.

• Evogene Ltd., of Rehovot, Israel, has granted exclusive rights to several of its genes that improve drought-stress tolerance primarily in corn and soybeans to Dupont subsidiary Pioneer Hi-Bred, of Des Moines, Iowa. The financial terms of the agreement were not disclosed. Pioneer will evaluate the licensed genes in its elite corn and soybean germplasm to measure the benefit in its commercial products. The candidate genes were discovered by Evogene's "Athlete" in-silico gene discovery technology.

• Helsinn Healthcare SA, of Lugano, Switzerland, and partner MGI Pharma Inc., of Minneapolis, have filed a supplemental new drug application for Aloxi (palonosetron hydrochloride) Capsules for treating postoperative nausea and vomiting (PONV). Aloxi Injection is approved by the FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The submission is based on results from two randomized, multicenter, Phase III trials evaluating the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV.

• Inion plc, of Tampere, Finland, said it is closing its research facility in Cambridge, UK, at a costs of £500,000 (US$1.1 million), to give annual savings of £1.5 million. The facility opened in November 2005 to identify the mode of action of N-methyl-pyrrolidone (NMP), the bioactive component in Inion's OptimaPLUS bone regeneration product and to strengthen the intellectual property surrounding NMP. Those activities have been completed. Development of OptimaPLUS is unaffected by the closure, and the clinical program will continue as planned. Inion, which is quoted on the Alternative Investment Market in London, said it is assessing the options for other intellectual assets created at the facility, which include six filed patents on bioactive molecules with novel modes of action.

• Medarex Inc., of Princeton, N.J., and Ono Pharmaceutical Co. Ltd., of Osaka, Japan, said the FDA has allowed the investigational new drug application for MDX-1106 (ONO-4538), a fully human anti-PD-1 antibody being investigated for the treatment of chronic viral infections, with the first trial to target hepatitis C. MDX-1106 was developed under the May 2005 research collaboration, and is already in a Phase I study in patients with recurrent or treatment- refractory cancer.

• Nycomed, of Zurick, Switzerland, has expanded its dermatology franchise in the U.S. by signing a definitive agreement to purchase Bradley Pharmaceuticals Inc., of Fairfield, N.J., for $20 per share, or $346 million. The purchase brings to Nycomed Bradley brand names such as Doak Dermatologics, in dermatology and podiatry, Kenwood Therapeutics, with products in the OB/GYN, respiratory and internal medicine markets, and A. Aarons, which markets generic versions of Doak and Kenwood therapies. The transaction has been approved by the Bradley board of directors, and is conditioned on approval by company shareholders, regulatory approvals and other customary closing conditions. Nycomed said it will fund the acquisition through "strong generation of excess cash in 2007," plus commitments by current investors and credit facilities. The acquisition is expected to be completed in the first quarter of 2008. The privately owned Nycomed said it intends to delist Bradley.

• Osmetech plc, of London, licensed exclusive rights to a new warfarin biomarker discovered at the Marshfield Clinic in Marshfield, Wis., which it will use to develop and market a genetic test that will more accurately determine the initial level of warfarin, an anticoagulant, that should be prescribed to individual patients. Financial terms were not disclosed.

• Rosetta Genomics Ltd., of Rehovot, Israel, said it successfully completed the prevalidation phase for its first diagnostic test. Using a single microRNA, the test is designed to differentiate squamous from nonsquamous lung cancer with high sensitivity and specificity. Rosetta's diagnostic tests are undergoing validation testing, and it expects three diagnostic tests to be launched in 2008, including a test for cancer of unknown primary, lung cancer vs. mesothelioma, and the squamous vs. nonsquamous lung cancer test which recently passed the prevalidation phase.

• SkyePharma plc, of London, and Sciele Pharma Inc., of Atlanta, said that the Prescription Drug User Fee Act date for their supplemental new drug application for a new formulation of Sular, a calcium-channel blocking agent for the treatment of high blood pressure, has been extended to Jan. 2, 2008. The new Sular formulation utilizes SkyePharma's Geomatrix technology, which is designed to provide a lower dose of Sular for each of its current doses.

• Summit Corp. plc, of Oxford, UK, signed a $450,000 deal with a large undisclosed pharmaceutical company for use of its zebrafish technology in drug discovery and development. The pharma firm will use Summit's platform to assess a significant number of compounds for safety and toxicity effects in a range of organs that are conserved between the zebrafish and humans, including the heart, liver, brain and gut. This extended pilot deal follows the conclusion of an earlier validation study conducted between the two companies.

• ThromboGenics NV, of Leuven, Belgium, and co-development partner BioInvent International, of Lund, Sweden, said data published in Cell showed that antibodies against PIGF (placental growth factor) can inhibit both cancer tumor growth and the development of metastases in preclinical models, without affecting healthy tissues. The companies plan to advance their lead anti-PIGF monoclonal antibody, TB-403, into the clinic by the end of 2007.

• Vectura Group plc, of Chippenham, UK, announced positive data from a Phase II study of VR040 for the treatment of off episodes, debilitating periods of complete or partial immobility, in Parkinson's disease. VR040 is a formulation of apomorphine, delivered to the bloodstream by oral inhalation through the lungs using Vectura's dry powder inhalation technology. The study showed a statistically significant improvement in the primary endpoint of mean change in the unified Parkinson Disease rating scale. There was a high rate of restoration of mobility, with 81 percent of patients achieving the same response as achieved with their usual dose of levodopa. There was a rapid onset of action with the majority of patients responding within 10 minutes and a mean duration of effect of 75 minutes. The next stage in developing VR040 will be to determine the optimal dose.