• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said the European Committee for Medicinal Products for Human Use recommended approval of exenatide in Type II diabetes. Marketing authorization by the European Commission is expected later this year. If approved, the drug will be marketed in Europe as Byetta, the same brand name as in the U.S.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., closed its previously reported $43.3 million equity sale of 5.5 million common shares at $8.50 apiece. The specialty pharmaceutical company expects to use net proceeds for general corporate purposes, including working capital, product development and capital expenditures. Thomas Weisel Partners LLC served as lead placement agent, and Roth Capital Partners LLC acted as co-placement agent. (See BioWorld Today, Sept. 18, 2006.)

• ChemBridge Corp., of San Diego, and ChemBridge Research Laboratories Inc., also of San Diego, entered a multiyear collaboration in discovery chemistry with AstraZeneca plc, of London, to develop exclusive small-molecule libraries enhancing AstraZeneca's global drug discovery effort. Further details and financial terms were not disclosed.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, entered a cell line engineering service agreement with Y's Therapeutics Inc., of Burlingame, Calif. Chromos will engineer cell lines specific for the expression of a recombinant protein of Y's using the ACE System, and Y's Therapeutics has the option to use the cell lines for scale-up and manufacture of the protein product under agreed license terms, following the cell line engineering phase of the agreement. Financial terms were not disclosed.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, will undertake a three for seven renouncable rights issue at 39 cents to fund the development of its drug, CUV1647 in Phase II/III trials. Tolhurst Noall Ltd., an Australian stockbroking and financial planning firm, intend to underwrite the rights issue for A$25 million (US$18.9 million). Clinuvel is developing CUV1647 in a range of UV-related skin disorders, and has completed Phase I and Phase II trials, totaling 200 patients. The company is preparing to start Phase III studies.

• Debiopharm Group, of Lausanne, Switzerland, received European orphan drug designation from the Commission of the European Community for Debio-0513, formerly known as PTR-262, a dual altered ligand peptide analogue of the myasthenogenic epitopes of the acetylcholine receptor (AchR) for the treatment of myasthenia gravis (MG). Debio-0513, is a synthetic peptide that down-regulates autoimmune responses associated with myasthenogenic peptides.

• Gen-Probe Inc., of San Diego, submitted responses to the FDA's questions on its regulatory application to run the previously approved Procleix West Nile virus assay on the investigational Procleix Tigris system. The agency's questions were included in a review letter on the company's biologics license application submitted in April.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., said Swiss regulators approved telbivudine for chronic hepatitis B in compensated patients with evidence of viral replication and active liver inflammation. It will be marketed there as Sebivo. The oral pill, which is taken once daily to suppress replication of the virus, is partnered with Novartis AG, of Basel, Switzerland. It remains under review in the U.S., Canada, Europe and elsewhere.

• Pozen Inc., of Chapel Hill, N.C., received the $40 million initial up-front payment from London-based AstraZeneca plc in connection to the collaboration signed last month to develop fixed-dose combinations of naproxen and AstraZeneca's esomeprazole for chronic pain. The deal could be worth up to $375 million to Pozen, including milestones. (See BioWorld Today, Aug. 3, 2006.)

• Trophos SA, of Marseille, France, extended its collaboration to discover and develop drugs for Huntington's disease with the nonprofit organization CHDI Inc., of Los Angeles. The development program builds upon a successful collaboration to identify compounds that confer a survival benefit on primary striatal neurons subjected to Huntington-mediated toxicity in assays enabled by Trophos' screening platform. Further details and financial terms were not disclosed.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed its previously announced public offering of 9.1 million shares for gross proceeds of $300.3 million. Shares were priced at $33 apiece. Funds will be used for general corporate purposes. (See BioWorld Today, Sept. 18, 2006.)

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