• Ablynx, of Ghent, Belgium, has achieved a second milestone in its collaboration with Proctor & Gamble Co., of Cincinnati, by the discovery of novel Nanobodies against a second target for possible new treatments in the musculoskeletal area. The first milestone was achieved in December 2006 and was also a target for musculoskeletal diseases. In the collaboration, Ablynx is responsible for discovering Nanobodies that meet an agreed product profile and P&GP is responsible for the pre-clinical and clinical development and commercialization of any resulting drug products.
• Active Biotech AB, of Lund, Sweden, presented preclinical results for its I-3D program at the annual European League Against Rheumatism conference. Data showed I-3D had a significant inhibitory effect on disease development in an experimental model for rheumatoid arthritis, and an additive inhibitory effect on disease development was achieved when combined with methotrexate. The compound is a small-molecule inhibitor of human dihydroorotate dehydrogenase. It is being developed in collaboration with Chelsea Therapeutics International Ltd., of Charlotte, N.C. A drug candidate is expected to be selected this year.
• Algeta ASA, of Oslo, Norway, said a paper showing the potential of its TH-1 technology for targeted cancer therapy was published in the journal Blood. Algeta's TH-1 technology links thorium-227, which emits alpha particles, to cancer-targeting molecules such as antibodies. The paper describes how researchers linked thorium-227 to the monoclonal antibody rituximab (Rituxan) to create 227Th-rituximab. It also included demonstrations of antitumor effects in vitro and in preclinical models. In other news, Algeta is extending its research agreement with the Norwegian Radium Hospital on development of new cancer therapeutics based on target-seeking alpha-emitting molecules. The partnership is focused on studying the effects of targeted radiotherapy treatment on lymphoma. The monoclonal antibody rituximab was linked to the alpha emitter Thorium-227 and tested in preclinical lymphoma models. The new agreement also will include development of Thorium-227 linked products aimed at treating breast cancer, for which highly characterized molecular targets already exist (such as HER2) and against which treatments have and are being developed.
• Allergy Therapeutics plc, of Worthing, UK, said its Pollinex Quattro Grass Phase III trial which began in January now is fully recruited and that the path to marketing approval during 2009 is clear after the company agreed with the safety study protocol of the FDA. The set-up for the study already has begun. Initial results are expected around the end of the first quarter of 2008 with full data expected in midyear. Those trials, if successful, are suitable for registration in both the U.S. and Europe.
• Asterand plc, of Royston, UK, a supplier of human tissue services, announced changes to its strategy following the appointment of Martyn Coombs as CEO on March 26. The company intends to restructure the UK operations; improve sales and marketing by increasing the cross-selling of tissue supply and drug discovery activities, better integrating the U.S. and European sales teams, and getting its scientists involved in the selling process; and improve the logistics of tissue supply operations in Detroit. The company has been hit by changes introduced earlier this month by the Russian Federal Customs Service restricting the export of human biological materials. The impact of those restrictions on Asterand's business still is being assessed.
• BioAlliance Pharma SA, of Paris, has reached agreement with the French Economic Committee for Health Products on the pricing in France of Loramyc, its 50-mg, once-a-day topical formulation of miconazole. BioAlliance accepted a price of €4 (US$5.37) a day, after France's Higher Health Authority decided that the state health insurance system should reimburse 65 percent of the price paid by patients. Loramyc thus will be added to the list of drugs that are reimbursed by the social security system and to the list of medicines approved for use in hospitals and various public services in France. The drug received marketing approval in France last October for the treatment of oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV. BioAlliance is hoping to launch the product on the French market later this year. It has set up its own sales force for selling the drug in France, whereas in other European countries Loramyc will be marketed by SpeBio, a 50:50 joint venture between BioAlliance and Spepharm Holding BV, of Amsterdam, that was established earlier this month.
• BioSystems International, of Evry, France, coordinator of the European COLBRED (Colon and Breast Cancer Diagnostics) consortium, announced that the project had received funding of €2.9 million (US$3.89 million) from the European Commission. The consortium is due to deliver within three years a panel of biomarkers/candidate diagnostics validated on preclinical models ready for large-scale clinical validation, with a view to commercial development by the three industrial members of the consortium. While the primary aim is to discover monitoring markers, BioSystems said it is more than likely that another use for the candidates identified will be as screening tools for the early diagnosis of cancers. The other two industrial members of the consortium are Ipsogen, of Marseille, France, and Biocrates, of Innsbruck, Austria, while the consortium also includes two leading cancer research institutes - Institut Marie-Curie, of Paris, and Institut Gustave Roussey, of Villejuif - as well as the universities of Innsbruck, Debrecen (Hungary) and Tartu (Estonia).
• DeCode Genetics Inc., of Reykjavik, Iceland, said it reached a favorable settlement of its litigation in Federal District Court in Philadelphia with the Children's Hospital of Philadelphia and several former DeCode employees who left the company to work for the hospital. The parties will exchange mutual releases, and the litigation will be dismissed with prejudice, DeCode said. The hospital and the individual defendants have certain undisclosed obligations to DeCode, the company said. In other news, DeCode said it has completed a sale and leaseback of its Woodridge, Ill., medicinal chemistry facility. The company sold the facility for $25 million to an unnamed buyer and has entered into a lease with an initial term of 17 years. After costs associated with the outstanding mortgage on the facility, taxes and expenses, deCODE netted $18.4 million, resources the company can apply to its drug and diagnostic development programs.
• Eurand NV, of Milan, Italy, said Eurand Pharmaceuticals Ltd. initiated the rolling submission of its new drug application for Zentase to treat exocrine pancreatic insufficiency. Zentase, formerly EUR-1008, has been granted fast-track designation by the FDA. The filing includes results from two Phase III studies demonstrating that Zentase, a porcine-derived pancreatic enzyme product, showed a clinically relevant increase in the absorption of fat, protein and other nutrients, which is maintained over time.
• Evogene Ltd., of Rehovot, Israel, and Bayer CropScience, of Monheim am Rhein, Germany, have formed a collaboration to increase the productivity and yield of a Bayer CropScience core crop, especially with regard to stress conditions such as drought. Under the agreement, Bayer CropScience has exclusively licensed the rights to certain genes discovered by Evogene that have demonstrated improved plant yield and other performance enhancements in various plant species. Evogene is to receive an initial fee, success-based milestone payments and royalties on sales. No specific terms were announced.
• Evotec AG, of Hamburg, Germany, said it enhanced its Fragment-Based Drug Discovery business through the acquisition of certain assets from Combinature Biopharm, now a unit of Singapore-based MerLion Pharmaceuticals Pte. Ltd. Evotec acquired equipment and expertise in nuclear magnetic resonance screening as well as access to the SAR-by-NMR intellectual property, licensed from Abbott Laboratories, of Abbott Park, Ill. Evotec plans to integrate the technologies with its high-throughput, high-concentration biochemical assay approach. The acquisition will add a library of fragments, bringing Evotec's fragment library to 30,000, it said. Terms of the deal were not disclosed.
• Genexine Co. Ltd. and Dong-A Pharmaceutical Co. Ltd., both of South Korea, entered into a collaboration covering co-commercialization of first-generation protein drugs under development at Dong-A and co-development of second-generation protein drugs using Genexine's hybrid Fc-fusion technology. A focus is commercialization for foreign markets of Gonadopin, a recombinant human follicle-stimulating hormone used for infertility treatment. They also plan to develop an interferon-beta agent for multiple sclerosis. Terms of the deal were not disclosed.
• Janssen-Cilag International NV, of Beerse, Belgium, has submitted a marketing authorization application to the European Medicines Agency for ceftobiprole, an investigational antibiotic for the treatment of complicated skin and soft tissue infections including diabetic foot infections. Ceftobiprole, the first broad-spectrum, anti-MRSA cephalosporin antibiotic to complete Phase III clinical trials, has demonstrated clinical activity against Gram-positive as well as Gram-negative pathogens. In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly methicillin-resistant Staphylococcus aureus. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd., of Basel, Switzerland, and Cilag GmbH International, of London. Janssen-Cilag companies will market the product in European countries and co-promote the product with Basilea in the major European markets. A new drug application for ceftobiprole has been submitted in the U.S.
• NicOx SA, of Sophia Antipolis, France, and the U.S. National Cancer Institute have decided to put an end to a Phase I clinical trial of NCX 4016, in which the drug was being tested as a potential preventive treatment for colon cancer. The decision was taken as a precautionary measure following the results of preclinical tests in vitro of the genotoxicity of NCX 415, a potential specific metabolite of NCX 4016. The French company pointed out that the results did not accord with earlier genotoxicity tests of NCX 4016, nor with an in vivo test of NCX 4015 that showed an absence of genotoxicity. But it nevertheless has decided to defer two planned Phase II trials of NCX 4016 in the indication of Type II diabetes, pending the completion of additional tests of NCX 4015. In May, NicOx halted the development of another drug candidate, NCX 1000, which was undergoing a Phase IIa clinical trial for the treatment of portal hypertension and was being co-developed with Axcan Pharma, of Mont-Saint-Hilaire, Quebec.
• OncoMethylome Sciences SA, of Liege, Belgium, and Exact Sciences Corp., of Marlborough, Mass., entered agreements to advance the commercialization of stool-based colorectal cancer screening technologies through service laboratories in Europe and North America. Under the terms, Exact granted nonexclusive rights to its DNA stabilization, isolation and extraction technology to OncoMethylome for screening tests using OncoMethylome's methylation detection technology. In exchange, OncoMethylome agreed to pay royalties to Exact based on sales.
• Oxford Gene Technology, of Oxford, UK, has granted Aushon BioSystems, of Burlington, Mass., access to OGT's Southern array patents, the fundamental patents covering the manufacture and marketing of oligonucleotide microarrays. The license enables Aushon BioSystems to manufacture and sell oligonucleotide microarrays worldwide, and to perform services based on oligonucleotide arrays. The license will remain valid for the patents' lifetime. Financial details were not disclosed.
• Rosetta Genomics Ltd., of Rehovot, Israel, signed a license agreement with Rockefeller University in New York for the therapeutic application of microRNA genes. Rosetta said the addition of the viral and human microRNAs to existing intellectual property estate gives it access to more than 500 proprietary microRNA drug targets for use in development of therapeutics and diagnostics. Terms of the deal were not disclosed.
• Transgene SA, of Strasbourg, France, successfully completed the capital increase it launched on June 11 in which 4.77 million new shares were placed at a price of €18.25 (US$24.49) per share. The institutional investors' placement was five times oversubscribed, and the 15 percent extension option was exercised in full. The offering raised gross proceeds of €87 million, and that could reach €100 million if the 15 percent overallotment option offered to the lead manager and bookrunner, Bryan Garnier & Co., of Paris, also is exercised in full. The new shares represent 22.3 percent of Transgene's capital and 16.7 percent of the voting rights post-offering. Transgene's controlling shareholder, TSGH, part of the Paris-based Merieux-Alliance group, subscribed to 55 percent of the offering, increasing its holding in the company from 52.4 percent to 52.9 percent.
• Vegenics Ltd., of Melbourne, Australia, has licensed from CoGenesys Inc., of Rockville, Md., exclusive worldwide rights to human monoclonal antibodies that target vascular endothelial growth factor-C (VEGF-C). VEGF-C is believed to play an important role in promoting the formation of new blood vessels and the maintenance of existing blood vessels. In oncology, inhibition of VEGF-C is a promising new approach to restricting blood and nutrient supply that supports tumor growth. Terms were not disclosed. CoGenesys, Inc. was spun out of Human Genome Sciences, Inc. in June of 2006 when it obtained an exclusive worldwide license to human monoclonal antibodies to VEGF-C.