• 3SBio Inc., of Shenyang, China, said it filed with Chinese regulators for approval of a 36,000 IU dosage formulation of Epiao in chemotherapy-induced anemia. The application was based on clinical data showing that weekly subcutaneous injection of Epiao demonstrated a hemoglobin improvement of 1-1 g/dL from baseline in 70 percent of oncology patients.

• Array BioPharma Inc., of Boulder, Colo., presented preclinical data on a novel small-molecule glucokinase activator, ARRY-403, for the treatment of Type II diabetes. The data showed that the product candidate demonstrated potent, highly glucose-blood-level-dependent control of both fasting and nonfasting glucose concentrations. Based on those and other results, Array plans to advance ARRY-403 into human clinical studies in the first half of 2009. The data were presented at an annual metabolic diseases conference in London.

• Cell Therapeutics Inc., of Seattle, said it was notified by Nasdaq that it had regained compliance with the minimum bid price requirement for continued listing on the global market. The company said it is continuing its efforts to regain compliance with Nasdaq's marketplace rule requiring a minimum market value of listed securities of $50 million by Oct. 6.

• Debiopharm Group, of Lausanne, Switzerland, said it has submitted an application to European regulators for the approval of its new six-month formulation of Decapeptyl (triptorelin pamoate 22.5 mg), a luteinizing hormone-releasing hormone agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Once approved, the Decapeptyl six-month formulation will be marketed by Debiopharm's partners, including Ipsen SA, of Paris, in most European Union countries.

• Ikaria Holdings Inc., of Clinton, N.J., said preclinical studies showed that its hydrogen sulfide drug candidate, IK-1001, reduced infarct size and protected against myocardial apoptosis in response to an ischemia-reperfusion injury in a two studies involving a porcine model. Results of a porcine study, published in Shock, demonstrated that the compound reduced various markers of injury and provided statistically significant hemodynamic stabilization. The company expects to start a Phase IIa trial in cardiopulmonary bypass surgery later this year.

• ImaRx Therapeutics Inc., of Tucson, Ariz., completed the sale of its urokinase program to Toronto-based Microbix Biosystems Inc. Microbix will pay ImaRx $2 million up front and assume $500,000 in liabilities. An additional $2.5 million milestone payment is tied to the FDA's release of three lots of the clot-busting drug, which were nabbed for stability issues. Microbix originally agreed to buy the urokinase program for $17 million, but the FDA's concerns altered the deal. (See BioWorld Today, May 8, 2008, and June 12, 2008.)

• Intercell AG, of Vienna, Austria, received a €40 million (US$58.5 million) payment from partner Novartis AG, of Basel, Switzerland, associated with the completion of an undisclosed milestone under the companies' 2007 vaccine deal. Intercell has received €270 million from the deal, which covers an adjuvant, an antigen platform and a hepatitis C vaccine. (See BioWorld Today, July 5, 2007.)

• Lonza Group, of Basel Switzerland, and Crucell NV, of Leiden, the Netherlands, have entered into a co-exclusive manufacturing, sales and distribution agreement related to the Permexcis cell culture medium, chemically defined cell culture medium that does not contain human- or animal-derived components, which was developed by Crucell for PER.C6 cells. Under the deal, Lonza will manufacture the medium and will market and sell it on a global basis. Financial details of the agreement were not disclosed.

• MDRNA Inc., of Bothell, Wash., was notified by Nasdaq that the company's common stock has closed below the $1 per share minimum bid for 30 consecutive business days. The company has until March 18, 2009, to regain compliance.

• Morphotek Inc., of Exton, Pa., a subsidiary of Eisai Corp. of North America, obtained an option to license Los Angeles-based Pivotal BioSciences Inc.'s monoclonal antibody platform, which is intended to increase the immune response to tumors. Terms of the deal were not disclosed.

• Mymetics Corp., of Nyon, Switzerland, said results from its preliminary SHIV challenge in nonhuman primates immunized with its mucosal HIV-AIDS vaccine significantly exceeded the industry standard of 60 percent to 70 percent effectiveness. The company expects to conduct further tests of its vaccine, which uses mucosal antibody protection, and Phase I trials are expected to start in November.

• PDL BioPharma Inc., of Redwood City, Calif., named Faheem Hasnain president and CEO, as well as director, effective Oct. 1. Following the company's planned separation of its biotech and royalty operations, Hasnain will head the spin-off company, which will be known as Facet Biotech Corp. PDL decided to spin out its biotech assets in April. (See BioWorld Today, April 14, 2008.)

• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, submitted a new drug application for a Type II diabetes drug that combines the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin with the thiazolidinedione Actos (pioglitazone HCl). Alogliptin was licensed to Takeda by contract research group PPD Inc., of Wilmington, N.C., which would receive royalties on sales if approved. (See BioWorld Today, July 15, 2005.)

• UCB SA, of Brussels, Belgium, said it is withdrawing its marketing application in Europe for Vimpat (lacosamide) in diabetic neuropathic pain based on the Committee for Medicinal Products for Human Uses' view that the magnitude of the clinical effect of the drug has not been established. Following consulting with the agency, UCB would need to initiate an additional study. Vimpat previously was approved in the European Union for the adjunctive treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy.

• Vermillion Inc., of Fremont, Calif., said its stock was delisted from the Nasdaq Capital Market, effective Sept. 25, as a result of the company's noncompliance with the minimum stockholders' equity requirement. Its shares now are trading on the Pink Sheets under the symbol "VRML."