• Adolor Corp., of Exton, Pa., said the FDA placed the investigational new drug application for ADL5859 on clinical hold pending additional preclinical safety studies and information regarding the proposed Phase I protocol. The company estimates that it will take about six months to get that information to the FDA. ADL5859 is an oral compound targeting the delta opioid receptor.

• AEterna Zentaris Inc., of Quebec City, Canada, reached an agreement with partner Solvay Pharmaceuticals Inc., of Marietta, Ga., to regain exclusive worldwide (except Japan) rights to its lead luteinizing hormone-releasing hormone antagonist drug candidate, cetrorelix, for the benign prostate hyperplasia indication. Solvay will not receive any financial compensation, and intends to pursue cetrorelix in an ongoing clinical program in endometriosis. AEterna Zentaris anticipates moving forward on a Phase III program in BPH, either alone or with a new partner.

• Affymax Inc., of Palo Alto, Calif., initiated a Phase II trial of Hematide to treat anemia in cancer patients. Hematide, a peptide-based drug designed to stimulate the production of red blood cells, also is being evaluated in a Phase IIb trial in hemodialysis patients with end-stage renal disease, and in a Phase IIb trial in chronic kidney disease patients who are not on dialysis and who have not been treated previously with erythropoietin.

• Albany Molecular Research Inc., of Albany, N.Y., signed a stock purchase agreement to acquire ComGenex Inc., of Budapest, Hungary, a company that provides chemistry services to the industry, and generated about $8.5 million in contract revenue in 2005. Financial terms were not disclosed. The transaction is expected to be completed by the end of the first quarter.

• Asterand plc, of Detroit, licensed rights to a series of compounds to treat conditions such as migraine to BTG plc, of London. BTG plans to advance the development of molecule BGC20-1531 into clinical trials, and will evaluate it and other molecules for other therapeutic indications. Terms call for Asterand to receive an undisclosed down payment, plus development milestones and royalties.

• AtheroGenics Inc., of Atlanta, said early termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period has been granted for the company's exclusive licensing agreement with London-based AstraZeneca plc for the worldwide rights to AGI-1067, AtheroGenics' Phase III-stage compound for atherosclerosis. The end of the waiting period triggers the $50 million up-front payment to AtheroGenics in the collaboration. (See BioWorld Today, Dec. 23, 2005.)

• Avanir Pharmaceuticals Inc., of San Diego, completed the submission of its new drug application for Neurodex, seeking marketing approval of the drug to treat pseudobulbar affect or emotional lability. The application was resubmitted to provide an expansion of certain summary analyses to better support the electronic common technical document. Avanir reported in September that the FDA had requested additional data in the NDA. (See BioWorld Today, Sept. 23, 2005.)

• BioLineRx Ltd., of Jerusalem, signed two license agreements for the development and commercialization of BL2050 to treat peripheral vascular disease and BL-2060, an antibiotic. Financial terms were not disclosed. The company also reported that it has terminated its BL-1050 program for the treatment of HIV.

• Cellomics Inc. of Pittsburgh, and Evotec Technologies GmbH, of Hamburg, Germany, entered a worldwide, nonexclusive license agreement to provide Evotec with the use of Cellomics' core High Content Screening patent portfolio. Financial terms were not disclosed.

• Icagen Inc., of Research Triangle Park, N.C., said an independent data monitoring committee recommended that the company continue with its pivotal Phase III trial of ICA-17043 in sickle cell disease, following the first per protocol interim safety review. The 300-patient study is studying vaso-occlusive crisis rate as its primary endpoint.

• Inspire Pharmaceuticals Inc., of Durham, N.C., plans to begin a Phase III program to advance denufosol tetrasodium for cystic fibrosis, following a successful end-of-Phase II meeting with the FDA. The Phase III program will be aimed at developing denufosol for CF as an early intervention therapy in patients with mild lung diseases, and two pivotal Phase III studies will use the pulmonary function test, FEV1 (Forced Expiratory Volume over one second) as the primary endpoint.

• Medarex Inc., of Princeton, N.J., received a milestone payment from its licensing partner, New York-based ImClone Systems Inc., following the acceptance of an investigational new drug application for a fully human IgG1 antibody in cancer. That antibody was developed using Medarex's UltiMAb technology, and the company could receive future milestone payments plus royalties if the product successfully completed trials and reaches the market.

• Theravance Inc., of South San Francisco, intends to offer 4.6 million shares of its common stock in a public offering, and expects to grant underwriters an overallotment option to purchase an additional 600,000 shares. Theravance focuses on small-molecule candidates to treat respiratory disease, bacterial infections, and gastrointestinal disorders.

• York Pharma plc, of Hitchin, UK, selected carbenoxolone as the lead compound from a class of vitamin A metabolic pathway inhibitors to be developed as a topical psoriasis treatment. Recent Phase II data showed that the compound demonstrated favorable signs of clinical effect in patients with mild to moderate psoriasis. York intends to carry out further Phase II trials with an optimized formulation of carbenoxolone, including dose-ranging studies, before moving into Phase III development.

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