• Access Pharmaceuticals Inc., of Dallas, signed a definitive agreement to acquire Somanta Pharmaceuticals Inc., of Irvine, Calif., two months after the companies signed a letter of intent to merge their businesses. Under the terms, Access will issue 1.5 million shares of common stock to Somanta stockholders in exchange for all the outstanding capital stock of Somanta. The merger has been approved by both companies' boards, and Access received voting agreements from shareholders representing about 81 percent of Somanta's outstanding common shares and about 60 percent of its outstanding preferred shares. The transaction, which will add Somanta's cancer drugs to Access' pipeline, is expected to be completed during the summer. (See BioWorld Today, Feb. 22, 2007.)

• Allos Therapeutics Inc., of Westminster, Colo., said the European Commission granted orphan drug designation to its antifolate PDX (pralatrexate) for patients with peripheral T-cell lymphoma. That designation could guarantee 10 years of marketing exclusivity in the European Union upon approval. PDX, a small-molecule chemotherapeutic agent designed to inhibit dihydrofolate reductase, previously received orphan drug and fast-track status from the FDA in T-cell lymphoma.

• Bavarian Nordic A/S, of Kvistgard, Denmark, appointed Anders Hedegaard as its new CEO. The company's previous CEO, Peter Wulff, will stay on in corporate management as the head of business development.

• Critical Therapeutics Inc., of Lexington, Mass., reported preclinical research that demonstrates a role in chronic inflammatory autoimmune disease for High Mobility Group Box-1 protein, a pro-inflammatory mediator and nuclear DNA-binding protein. Data show that HMGB1 is part of DNA complexes that can stimulate immune cells to produce inflammatory mediators, which in turn can contribute to the inflammatory pathology of autoimmune disease. That research will be published in the May issue of Nature Immunology.

• Carrington Laboratories Inc., of Irving, Texas, said its wholly owned subsidiary, DelSite Biotechnologies Inc., secured a source of influenza antigen for a planned Phase I trial of a nasal powder influenza vaccine based on its GelVac dry-powder technology. Pending successful toxicological studies, it would be the first influenza nasal powder vaccine to be used in a human clinical trial, Carrington said. The company has completed a Phase I safety study of the GelVac powder system without antigen.

• Cytomedix Inc., of Rockville, Md., learned that the FDA plans to consult with external experts in the wound care and hematology area to seek their opinions on the safety of bovine thrombin as it is used in the company's AutoloGel System. Cytomedix's application for marketing clearance of the system is under review by the FDA. In the past five weeks the company has responded to FDA requests relating to the application and has outlined a post-marketing surveillance study to address the agency's concerns on the use of bovine thrombin. The AutoloGel System is a technology designed to use an autologous platelet gel composed of multiple growth factors and fibrin matrix for healing diabetic foot ulcers.

• Emergent BioSolutions Inc., of Rockville, Md., said the Department of Health and Human Services and the Department of Defense issued two separate notices of intent to procure up to a combined total of 22.75 million doses of BioThrax (anthrax vaccine adsorbed). The HSS stated its intent to buy 10.4 million doses for the strategic national stockpile, with options for up to an additional 8.35 million doses. HHS plans to enter sole negotiations with the company to finalize the award on or about July 24. Separately, DoD issued a special notice signaling an anticipated sole source contract award to buy a minimum of 4 million doses of BioThrax, over a base period and three optional ordering periods. Since 1998, Emergent BioSolutions has delivered 19 million doses of BioThrax under HHS and DoD contracts.

• Geron Corp., of Menlo Park, Calif., developed standardized hepatocytes from human embryonic stem cells that can model human hepatic drug metabolism. A paper published in Cloning and Stem Cells describes an improved procedure to differentiate hepatocytes that exhibit characteristic hepatocyte morphology and express several hepatocyte markers, including albumin and HepPar1. The hESC-derived hepatocytes also possess functional activities, including p450 metabolism, albumin production, glycogen storage and uptake and excretion of indocyanine green.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., has submitted a supplemental new drug application to the FDA seeking to reintroduce Valstar into the marketplace. The compound, a sterile solution for bladder cancer, was approved by the FDA in 1998, but was removed from the market four years later due to issues related to the stability of an inactive ingredient. Indevus said the stability issues have been resolved through changes in the manufacturing process, and it hopes to reintroduce the drug by the end of 2007. Valstar is the only drug approved for treating Bacillus Calmette-Guerin refractory bladder cancer in patients who are not candidates for surgical bladder removal. Announcement of the new application came one day after Indevus and Valera Pharmaceutical Inc., of Cranbury, N.J., said they had completed their merger agreement.

• Lexicon Genetics Inc., of The Woodlands, Texas, said its collaboration with South San Francisco-based Genentech Inc. yielded a potential therapeutic target, designated LG842, and has developed antibodies for that target. The companies presented data showing that the deletion or neutralization of LG842, a circulating protein expressed predominantly in adipose tissue, placenta, pancreas and liver, resulted in lower triglycerides and cholesterol in in vivo models. Those data were reported at the Society for Biomolecular Sciences conference in Montreal. Under the companies' 2002 collaboration, Lexicon has the option to choose six targets to advance into drug discovery efforts.

• MedImmune Inc., of Gaithersburg, Md., and Micromet Inc., of Carlsbad, Calif., said proof-of-concept data of BiTE molecule bscEphA2xCD3 show that the compound killed tumor cells at dose levels considerably below those required by classical monoclonal antibody-based therapies. BscEphA2xCD3 is a BiTE molecule targeting the tyrosine kinase receptor EphA2, which is frequently overexpressed on a variety of solid tumors. Those in vitro and in vivo data, collected from cell culture experiments conducted under the companies' BiTE technology research collaboration, were published in Cancer Research.

• Millenia Hope Inc., of Wilmington, Del., in consortium with the University of Pittsburgh and Rutgers University, was selected by the National Institutes of Health to receive more than $4.6 million over the next five years for a project, titled "HIV RNase H natural product inhibitors," to develop HIV therapeutics directed at ribonuclease H. The program is driven by Phytomics, Millenia Hope's technology for the production and isolation of plant cell culture-derived natural products to inhibit HIV RNase H, a viral target essential for HIV-1 replication.

• Novacea Inc., of South San Francisco, reached an agreement with KuDOS Pharmaceuticals Ltd., a wholly owned subsidiary of London-based AstraZeneca UK Ltd., and BTG plc, also of London, to acquire an exclusive license to an investigational cancer agent AQ4N (banoxantrone) for worldwide development and commercialization. Terms were not disclosed. Prior to its acquisition by AstraZeneca in 2006, KuDOS gained worldwide rights to AQ4N from BTG and subsequently licensed North American rights to Novacea. KuDOS anticipates that it will complete patient recruitment in its ongoing Phase I trials of AQ4n, a tumor-selective prodrug, in the middle of this year.

• ProBioGen AG, of Berlin, and Minapharm, of Cairo, Egypt, signed two separate agreements to develop two therapeutic proteins, one exclusively for Minapharm and another second-generation product for co-promotion. In the first agreement, ProBioGen will apply its cell generation process for biopharmaceutical cell lines and Minapharm, via its subsidiary, Rhein-Minapharm-Biogenetics, will carry out the pertinent process research and development, production and commercialization. The second deal calls for the companies to co-develop a second-generation product using either ProBioGen's pre-optimized CHO cell line or its Human Neuronal Cell Line AGE1.HN. Minapharm will exclusively market the product in Middle Eastern and African countries, while ProBioGen will retain promotional rights in the rest of the world. The companies will share revenue from the product. Specific financial terms were not disclosed.

• Vical Inc., of San Diego, signed a cooperative research and development agreement with the Naval Medical Research Center to explore the use of Vical's Vaxfectin adjuvant with experimental DNA vaccines against malaria. Vaxfectin is a cationic lipid/co-lipid formulation designed to increase the immune response to vaccines. The NMRC plans to conduct a series of antigen screening tests and further development in several animal models of malaria to optimize the design of a vaccine that potentially will lead to initial testing in humans. Terms were not disclosed.