• Affitech A/S, of Copenhagen, Denmark, appointed Robert Burns as CEO and Alexander Duncan as senior vice president of research and development. Burns was previously CEO of Celldex Therapeutics Inc., while Duncan hails from AstraZeneca plc. The appointments follow Affitech's merger with Pharmexa A/S. (See BioWorld Today, March 5, 2009.)

• Applied NeuroSolutions Inc., of Vernon Hills, Ill., appointed Craig S. Taylor as its president, CEO and a member of its board. Previously a partner at Adams Street Partners LLC, Taylor served as associate director of business development for G.D. Searle (now part of Pfizer) and was a senior research biochemist at Abbott Laboratories.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said that the FDA considers the response submitted by the sponsor Johnson & Johnson Pharmaceutical Research & Development LLC, of Raritan, N.J., as a complete, class 2 response. The submission addresses the FDA's November 2008 letter concerning the ceftobiprole new drug application for complicated skin and skin structure infections. Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd., also of Basel, and Cilag GmbH International, a J&J company. (See BioWorld Today, Dec. 1, 2008.)

• Bristol-Myers Squibb Co., of New York, completed its tender offer for shares of Medarex Inc., of Princeton, N.J. As of the expiration of the offering period, Medarex shareholders tendered about 120.4 million shares, which, along with the 2.9 million shares owned by BMS since 2005, represented about 90.7 percent of the shares outstanding. The two firms agreed to the $2.4 billion acquisition in July. (See BioWorld Today, July 24, 2009.)

• Cellectis SA, of Romainville, France, and Monsanto Co., of St. Louis, entered into a nonexclusive research and commercial license agreement for broad use of Celectis' meganuclease technology in plants. Cellectis will receive an up-front payment of €3 million (US$ 4.2 million), Monsanto will make an equity investment of €1 million to allow Cellectis to scale the technology for agriculture. Cellectis also will be eligible to receive fees for the development of each meganuclease, success-based milestones and may receive royalties on certain traits commercialized by Monsanto. Further financial details were not disclosed.

• Champions Biotechnology Inc., of Baltimore, entered a deal with an undisclosed large biotech company to evaluate an oncology therapeutic using Champion' Biomerk Tumorgraft platform, which is designed to enable identification of the most promising development path for a compound and also identify potential gene pathways of response and resistance, as well as prognostic molecular biomarkers. Terms were not disclosed.

• Clinical Data Inc., of Newton, Mass., sold the equipment and property associated with its wholly owned subsidiary - Germantown, Md.-based Avalon Pharmaceuticals Inc. - to Blacksburg, Va.-based Intrexon Corp. for $1.5 million cash. Clinical Data retains Avalon's oncology drug candidates, intellectual property and biomarker discovery platform, while Intrexon gets access to a bioassay platform to complement its transgene engineering platform.

• Medivir AB, of Stockholm, Sweden, selected MIV-711 as a candidate drug for bone diseases. MIV-711 is a small-molecule protease cathepsin K inhibitor distinguishable from MIV-710, and both drugs are being prioritized over MIV-701 for osteoporosis, osteoarthritis, rheumatoid arthritis and metastatic bone disease.

• Metabasis Therapeutics Inc., of San Diego, said its president, CEO and chief scientific officer, Mark Erion, resigned as an officer, effective Oct. 31. Erion, who also resigned his position on the board, will consult with the company after that date on matters related to the licensing or sale of its pipeline and advanced discovery programs or other strategic alternatives. Erion is joining Whitehouse Station, N.J.-based Merck & Co. Inc. as vice president and worldwide basis franchise head of diabetes and obesity. David Hale, Metabasis' chairman, was appointed executive chairman.

• MiddleBrook Pharmaceuticals Inc., of Westlake, Texas, has cut its sales managers and field sales representatives by 25 percent and reduced corporate staff by about 20 percent. As a result, the firm expects to achieve approximately $15 million in annual savings. The company said it now anticipates that its total operating expenses for 2009 will range between $78 million and $83 million, vs. its previous guidance of operating expenses ranging between $83 million and $88 million. It will continue to maintain sales coverage of the physicians with the highest potential to prescribe Moxatag (extended-release amoxicillin) Tablets, 775 mg.

• Neurobiological Technologies Inc., of Emeryville, Calif., has decided to liquidate the company's assets and to dissolve the company. The company intends to distribute the majority of its available cash to its stockholders. A stockholders meeting will be held to vote on the plan. As of June 30, the company reported having cash, cash equivalents and short-term investments of $24 million,

• Nuvo Research Inc., of Missisauga, Ontario, has entered into a cooperative drug development project with the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig, Germany, for the preclinical and clinical development of WF10 as a potential treatment for allergic rhinitis. The Development Bank of Saxony in Germany will provide financial support for the project, which will be conducted in Leipzig through Nuvo Research GmbH, a Nuvo subsidiary.

• Selexis SA, of Geneva, and NKT Therapeutics Inc., of Waltham, Mass., entered a research services deal under which Selexis will screen antibody variants and generate Chinese hamster ovary-based production cell lines using its Integra-D2M

• Shire plc, of Basingstoke, UK, said its final two Phase III trials for enzyme replacement therapy velaglucerase alfa met their endpoints in Type I Gaucher's disease and the company's rolling new drug application at the FDA has been completed. (See BioWorld Today, Aug. 4, 2009.)

• SkyePharma plc, of London, said that additional clinical work will be required to provide more data on dosing for its lead development product, Flutiform (fluticasone propionate/formoterol fumarate), for persistent asthma in patients 12 years of age and older. The need for additional clinical work was confirmed in a meeting with the FDA, the company said. Due to the additional work, the board believes that it is unlikely that Flutiform will be approved in the U.S. before the second half of 2011. In the meantime, the FDA's review of product is continuing.

• Stemedica Cell Technologies Inc., of San Diego, has been granted a license by the California Food & Drug Branch to manufacture stem cells for human clinical trials. The license recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

• Zealand Pharma AS, of Glostrup, Denmark, said it is moving its new generation drug candidate for Type II diabetes into preclinical development. The dual glucagon-GLP-1 agonist, ZP2929, has the potential to significantly decrease body weight and reduce the risk of diabetes-related complications, the company said.