• Akesis Pharmaceuticals Inc., of San Diego, filed an investigational new drug application with the FDA for lead product candidate AKP-020, a formulation of vanadium also known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. The filing followed feedback from the FDA on a pre-IND application submitted in July. Pending IND approval, Akesis plans to initiate in this quarter an open-label, single-arm, Phase IIa trial of AKP-020 in Type II diabetes.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., presented positive new preclinical nonhuman primate data demonstrating for its PCSK9 antagonism with an RNAi therapeutic. The data showed in vivo administration of an RNAi therapeutic resulted in efficient silencing of the PCSK9 gene, reducing PCSK9 plasma levels by up to 70 percent of pre-dose levels. It also found rapid reductions in LDL cholesterol levels by 40 percent to 60 percent, reduction in circulating apolipoprotein B (apoB) levels by 30 percent to 40 percent, and it was well tolerated. The data were presented at the International Symposium on Drugs Affecting Lipid Metabolism in New York.

• Asuragen Inc., of Austin, Texas, licensed real-time quantitative PCR technology from Roche Molecular Systems Inc., a division of Basel, Switzerland-based F. Hoffmann-La Roche Ltd. Asuragen will use the technology for clinical gene expression profiling and DNA analysis in its clinical service programs.

• Basilea Pharmaceutica Ltd., of Basel Switzerland, said Swissmedic has accepted for assessment the marketing authorization application of ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections. The application is subject to an accelerated review. The regulatory information was submitted by Basilea's license partner Janssen-Cilag AG, of Beerse, Belgium, a Johnson & Johnson company. Swissmedic previously granted accelerated assessment of the application. Ceftobiprole currently is under review by regulatory authorities in the U.S., Canada and the European Union.

• Cytomedix Inc., of Rockville, Md., said results of a cost-effectiveness analysis submitted to the Centers for Medicare & Medicaid Services showed that AutoloGel, a saline gel to control wound care therapy, is more effective and less costly than other alternative therapies for patients with diabetic foot ulcers. Results of the analysis, conducted by B&D Consulting, a Washington-based advisory and advocacy firm, showed that the estimated five-year average direct wound care costs of AutoloGel to treat the most commonly sized diabetic foot ulcers was about $15,000 compared with $24,000 to $47,000 for other therapies. The proposed decision memorandum due date for CMS's National Coverage Assessment (NCA) on platelet-rich plasma gel is Dec. 25, and the expected NCA completion date is March 24, 2008.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., reduced its pro forma net operating loss guidance downward from the mid- to high-$40 million range to the mid- to high-$20 million range, excluding noncash compensation expense. The company also presented additional data for ISIS 301012 (mipomersen sodium) at the Drugs Affecting Lipid Metabolism (DALM) XVI International Symposium in New York. In addition to Phase II data in patients with heterozygous familial hypercholesterolemia presented last week, the company presented preclinical data supporting liver safety and initial positive safety data from the ongoing, open-label, Phase II trial in patients with familial hypercholesterolemia.

• Laboratorios Almirall SA, of Barcelona, Spain, entered a definitive agreement to acquire a portfolio of eight marketed products along with their associated European sales teams from Shire plc, of Cambridge, UK. Almirall will pay Shire $213 million for the products, which include Solaraze (diclofenac sodium 3 percent gel) for actinic keratosis, Vaniqa (11.5 percent eflornithine) for facial hirsutism, Lodine (etodolac) for rheumatoid arthritis, Colazide (balsalazide disodium) for ulcerative colitis, Cebutid (flurbiprofen) for rheumatoid arthritis, Meptid (meptazinol) for pain, Robaxin (methocarbamol) for muscle relaxation and Mintec (peppermint oil BP) for irritable bowel syndrome.

• Martek Biosciences Corp., of Columbia, Md., has entered into a long-term supply agreement with Abbott Nutrition to serve as Abbott's exclusive worldwide DHA and ARA supplier for all of its infant formula products. The agreement provides for a 10-year term with Abbott having the right to terminate the arrangement as of January 2012. No terms were disclosed.

• MorphoSys AG, of Munich, Germany, has signed a research agreement with Genesis Research and Development Corp. Ltd., of Auckland, New Zealand, in which Genesis will continue to use MorphoSys' HuCAL-based antibodies against the human fibroblast growth factor receptor 5 (FGFR5) for target validation and preclinical studies as part of its proprietary Zyrogen program. Financial details of the deal were not disclosed. Genesis is investigating the development of therapeutic antibodies specific for the target molecule FGFR5, which is implicated in various autoimmune and bone-related diseases. Based on the scientific data generated by Genesis during the collaboration, the parties will discuss further development of the therapeutic program.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, said it intends to sell 3,726,708 shares of common stock in an underwritten public offering. Shares have not yet been priced. In addition, Protalix plans to grant underwriters a 30-day overallotment option to purchase a number of shares equal to 15 percent of the aggregate number of shares sold in the initial offering. The company is seeking to raise approximately $130 million. UBS Securities LLC is acting as sole book-running manager for this offering and CIBC World Markets Corp. is acting as a co-manager. Protalix has initiated enrollment and treatment of patients in its pivotal Phase III clinical trial of its lead product candidate, prGCD, for enzyme replacement therapy of Gaucher disease.

• PSivida Ltd., of Perth, Australia, said its financial statements for the fiscal year ended June 30 contain a going concern qualification from its independent accounting firm due to recurring losses and negative cash flows from operations. pSivida said it has sufficient cash to sustain operations through at least June 30, 2008.

• Trinity Biotech plc, of Dublin, Ireland, said its shareholders voted Oct. 1 to delist the company from the Irish Stock Exchange. The firm said it notified the exchange of its decision, which is anticipated to take effect on Nov. 5. The decision, the company said, will have no effect on its Nasdaq listing, of which 98 percent of all trading in the firm's shares takes place. Trinity Biotech develops, acquires, manufactures and markets diagnostic products used to detect sexually-transmitted and other infectious diseases, blood-coagulation disorders and autoimmune diseases.

• XOMA Ltd., of Berkeley, Calif., has appointed CEO Steven Engle chairman of the board of directors. Engle joined XOMA as its CEO, president and a director in August. He succeeds John L. Castello, who announced his plan to retire in February 2007 and agreed in August to continue serving on the board as its nonexecutive chairman through a transition period.