• Active Biotech AB, of Lund, Sweden, received SEK5 million (US$704,846) from Vinnova's (Swedish Governmental Agency for Innovation Systems) Research and Grow program. The funds will be used for preclinical work on drugs to treat autoimmune/inflammatory diseases, which will be performed in collaboration with Lund University.

• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said the European commission granted marketing authorization for Byetta (exenatide) as adjunctive therapy to improve blood sugar control in Type II diabetes patients. That approval follows a positive opinion adopted in September by the Committee for Medicinal Products for Human Use. Amylin and Lilly anticipated launching the product in 2007. Byetta received U.S. approval in May 2005.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., filed a universal shelf registration statement to permit the company, from time to time, to offer and sell up to $35 million in aggregate amount of its securities, which might consist of common stock, preferred stock or warrants. Cortex plans to use the proceeds from any sales to accelerate development of its Ampakine technology, as well as for working capital and other general corporate purposes.

• Crucell NV, of Leiden, the Netherlands, agreed to acquire Stockholm, Sweden-based SBL Vaccin AB, which develops vaccine products and markets Dukoral, an oral vaccine against cholera. Under the terms, Crucell agreed to pay €39.4 million (US$50.5 million) in cash. The acquisition is expected to be completed Nov. 23, 2006. In other news, Crucell said it intends to raise €80 million through the issue of new ordinary shares to fund the SBL acquisition, refinance the acquisition of Berna Products Corp., completed on Oct. 2, and to repay the outstanding debt of Berna Biotech AG.

• DOR BioPharma Inc., of Miami, said the FDA accepted its new drug application for orBec (oral beclomethasone dipropionate) for gastrointestinal graft-vs.-host disease and established a target action date of July 21. Orbec, a two-pill system, contains a topically active corticosteroid designed to target and treat upper- and lower-GI GVHD with reduced systemic immunosuppressive side effects. DOR filed the NDA in September, based on pivotal data that showed a 66 percent reduction in mortality at 200 days post-transplant. (See BioWorld Today, Sept. 25, 2006.)

• Palau Pharma, of Barcelona, Spain, brought in €40 million (US$51.3 million) through a private placement to fund its internal research and development operations. Palau, a spinout of Grupo Uriach's R&D unit, intends to focus on drug development for inflammatory and autoimmune conditions. The financing was led by Grupo Uriach and a group of four investors - Invercartera (Grupo Caixa Catalunya), Caja Duero, the Cerqueda family and Najeti Capital - with the latter acquiring a minority stake in Palau.

• Pharmion Corp., of Boulder, Colo., and Nippon Shinyaku Co. Ltd., of Kyoto, Japan, completed an exclusive license agreement for development and commercialization rights to Vidaza (azacitidine for injectable suspension) in Japan. Terms of the deal were not disclosed, though the agreement requires Nippon to pay both royalties and milestones to Pharmion and also places the responsibility on Nippon for funding and conducting any additional studies needed for Japanese regulatory approval. Vidaza is marketed in the U.S. for myelodysplastic syndromes.

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