• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly & Co., of Indianapolis, submitted a supplemental new drug applications to the FDA for Byetta (exenatide) injection as an add-on therapy to a common class of oral diabetes medication called thiazolidinediones in people with Type II diabetes who are not achieving acceptable blood sugar control. The drug was approved by the FDA in April 2005 to treat Type II diabetes as an add-on therapy in patients who are not achieving acceptable blood sugar control despite using metformin, a sulfonylurea or a combination of both.

• Applied Biosystems Group, of Foster City, Calif., said it completed its acquisition of the research products division of Ambion Inc., of Austin, Texas, a provider of products for the study and analysis of ribonucleic acid. The research and development, manufacturing and other operations of Ambion’s research products division will continue to be based in Austin, and its 300 employees will be integrated into the Applied Biosystems’ global work force.

• BioDelivery Sciences International Inc., of Morrisville, N.C., received a non-approvable letter from the FDA for its new drug application for Emezine, a buccal tablet formulation of prochlorperazine maleate to treat severe nausea and vomiting. The letter stated that additional information would be required to address remaining questions. BDSI has requested a meeting with the FDA and will use the outcome of the meeting to decide the direction it intends to pursue regarding Emezine. Accentia Biopharmaceuticals Inc., of Tampa, Fla., has the exclusive U.S. distribution rights to Emezine through its agreement with Arius Pharmaceuticals Inc., a BDSI subsidiary. BDSI’s stock (NASDAQ:BDSI) fell 75 cents Thursday, or 24 percent, to close at $2.38.

• Covalys Biosciences AG, of Witterswil, Switzerland, closed its Series C round of financing. The company is offering products based on the SNAP-tag technology used to study proteins for drug development and life science research. Investors included BVgroup Private Equity, Novartis Venture Fund and Venture Incubator.

• Diosynth Biotechnology, of Research Triangle Park, N.C., a unit of NV Organon, of Oss, the Netherlands, entered into a long-term commercial supply agreement with Dendreon Corp., of Seattle, for the manufacture of the recombinant antigen component of Provenge, an active cellular immunotherapy for prostate cancer. The product will be manufactured for commercial launch at Diosynth’s facility in North Carolina.

• Lexicon Genetics Inc., of The Woodlands, Texas, said Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, selected LG474 for therapeutic development. It is a hypertension target that was discovered by Lexicon in its Genome5000 program. Takeda’s selection entitles Lexicon to a $5 million research milestone payment.

• MaxCyte Inc., of Gaithersburg, Md., and Sangamo BioSciences Inc., of Richmond, Calif., formed a license, option, development and supply agreement to use MaxCyte’s cell loading system in Sangamo’s HIV/CCR5 ZFP therapeutic program. The companies will evaluate and further develop the system to load zinc finger DNA-binding protein-based therapeutics into cells. Sangamo also has the option to use MaxCyte’s system for ZFP therapeutics in oncology. The agreement gives Sangamo an option for a commercial license to the technology that includes a supply contract and clinical and commercial milestones to Maxcyte for products developed under the agreement.

• Nuvo Research Inc., of Markham, Ont., said the March 1, 2006, issue of the Journal of Rheumatology published a paper on Pennsaid, its topical non-steroidal anti-inflammatory in patients with osteoarthritis of the knee. The author of the paper concluded that Pennsaid is effective, had only minor localized skin reactions, and was as safe as the vehicle control placebo.

• UCB Pharma, of Atlanta, a unit of Brussels, Belgium-based UCB, submitted a biologics license application to the FDA for the approval of Cimzia (certolizumab pegol, CDP870) to treat Crohn’s disease. The BLA includes safety and efficacy data from clinical trials in more than 1,500 patients with Crohn’s disease. The pivotal studies met their primary endpoints by demonstrating that Cimzia induced clinical response and maintained clinical response and remission in a significant percentage of patients with the disease.

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