• Amylin Pharmaceuticals Inc., of San Diego, said the FDA issued a non-approvable letter for Symlin use with basal insulin in patients with Type II diabetes who have not achieved desired glucose control. The company did not provide details of the FDA's decision but said it intended to initiate discussions with the agency to clarify its response. Symlin (pramlintide acetate), an amylin mimetic, is approved for Type I and Type II diabetes patients who use mealtime insulin and need improved glucose control. In other news, Amylin reported that the FDA approved the SymlinPen 120 injection, pre-filled pen-injector devices that feature fixed dosing to improve mealtime glucose control.

• Argenta Discovery Ltd., of Harlow, UK, entered a fee-for-service contract drug discovery collaboration with CellCentric Ltd., of Cambridge, UK. The companies will utilize Argenta's screening and assay technologies to discover inhibitors for two potential epigenetic-related therapeutic targets. Terms were not disclosed.

• Avecia Biologics Ltd., of Tees Valley, UK, and Renovo Group plc, of Manchester, UK, entered an agreement for process development and manufacture of Renovo's developmental product, Prevascar, a therapeutic formulation of human recombinant interleukin-10 (IL-10). Under the deal, Avecia will carry out development work to optimize the drug manufacturing process and scale-up and will conduct further cGMP manufacture of IL-10 in Avecia's biologics facilities, with the goal of providing Prevascar in quantities to support ongoing trials. Financial terms were not disclosed.

• Biogen Idec Inc., of Cambridge, Mass., said findings from a preclinical study showed that its anti-LINGO-1 antibody can promote spinal cord remylination and axonal integrity and suggested a potential role as a treatment for multiple sclerosis and other demyelinating diseases of the central nervous system. LINGO-1 appears to act as a molecular switch that controls the ability of CNS cells to produce myelin, and Biogen scientists reported that by blocking LINGO-1, they were able to promote myelin repair and improve recovery in an animal model of MS. Results were published in Nature Medicine.

• BioLineRx Ltd., of Jerusalem, has signed a worldwide exclusive license agreement with Yeda Research and Development Company Ltd., of Rehovot, Israel, the technology transfer company of the Weizmann Institute of Science, to develop and commercialize BL-4050, a peptide for treating cancer. Financial terms were not disclosed. BL-4050 specifically attacks malignant cells, disrupting their membranes and inducing cell death. It is expected that mechanism of action may lead to lower levels of toxicity and resistance than current therapies. In addition, BioLineRx said BL-4050 is expected to have a wide spectrum of activity against many cancer types and has been shown effective in in vivo testing.

• Bionas GmbH, of Rostock, Germany, has signed a service contract with Solvay Pharmaceuticals GmbH, of Hannover, Germany, covering the metabolic profiling of several drug candidates identified in the context of Solvay s obesity research program. Financial details were not disclosed. Solvay will use the Bionas 2500 analyzing system to monitor both acute and chronic effects of drug candidates in different cell types.

• Clinical Data Inc., of Newton, Mass., said its PGxHealth division has entered into a nonexclusive sublicense agreement with the Victorian Clinical Genetics Services, of Australia, to provide genetic testing for familial long QT syndrome (LQTS) of individuals and families in Australia and New Zealand. No other terms of the deal were released. The genetic test aids in the diagnosis of LQTS, an inherited disorder of the heart's electrical system that causes a sudden, unexpected, life-threatening type of ventricular tachycardia commonly called torsades de pointes.

• Discovery Laboratories Inc., of Warrington, Pa., said its new process validation batches of Surfaxin (lucinactant) demonstrated acceptable stability at six months. The findings will be included in the company's response to the FDA's April 2006 approvable letter for Surfaxin in the prevention of respiratory distress syndrome in premature infants. The company remains on track to file its response this month and anticipates a six-month review cycle. Shares (NASDAQ:DSCO) rose 47 cents, or 17.5 percent, to close at $3.16 on Monday. (See BioWorld Today, April 6, 2006.)

• FASgen Inc., of Baltimore, said its fatty acid synthase inhibitor compounds, led by FAS031, demonstrated efficacy against every solid tumor xenograft cell line tested, in both orthotopic and flank models: four lung tumor cell lines, two ovarian, breast and colon. One compound was safely given to mice twice a day orally for six months with no observed adverse side effects, and other compounds were given to mice in a two-year experiment and prevented the onset of tumors in nearly one-third of the mice. The company is developing a clinical trial program to test those compounds in Phase I/II trials at the Johns Hopkins Oncology Center, with some funding coming from the National Cancer Institute.

• FivePrime Therapeutics Inc., of San Francisco, successfully achieved a target discovery milestone in its research collaboration with Ingelheim, Germany-based Boehringer Ingelheim GmbH. The April 2006 collaboration is a two-year alliance aimed at discovering protein and antibody targets to treat rheumatoid arthritis and other diseases using FivePrime's discovery platform. FivePrime recently identified proteins with activity in cellular systems that might accelerate efforts to develop drugs against RA. Under the companies' agreement, Boehringer has exclusive, worldwide rights to develop and commercialize products and targets discovered. (See BioWorld Today, April 27, 2006.)

• GammaCan International Inc., of Kiryat Ono, Israel, signed a second plasma supply agreement, under which DCI Biologicals Inc. will collect plasma from vitiligo donors for the manufacture of VitiGam, the company's lead product for Stage III and Stage IV melanoma. As part of that deal, GammaCan amended the exclusive plasma supply agreement with Clarkston, Ga.-based Life Therapeutics Inc. to nonexclusive. The company also is in discussions with additional plasma suppliers and anticipates signing at least one additional vitiligo plasma supply agreement. Financial terms were not disclosed.

• Monogram Biosciences Inc., of South San Francisco, established European operations to facilitate global access to its HIV diagnostic, the Trofile co-receptor tropism assay. Use of the diagnostic is required in the label for New York-based Pfizer Inc.'s HIV drug Selzentry (maraviroc), which recently gained European approval under the trade name Celsentri. Monogram and Pfizer have a collaboration to make Trofile available worldwide, with Pfizer taking the lead in ex-U.S. commercialization and Monogram providing support.

• Neurobiological Technologies Inc., of Emeryville, Calif., has been notified by Nasdaq that the company fails to comply with the market value of listed securities requirement for continued listing. The company has requested a hearing to appeal the determination. Delisting actions have been stayed pending the completion of the appeal, which is expected to be heard in three to six weeks.

• Novelos Therapeutics Inc., of Newton, Mass., in collaboration with the Medical University of South Carolina, was awarded a $150,000 Small Business Technology Transfer grant by the National Institutes of Health. The grant is intended to support further scientific development of NOV-002, Novelos' lead compound in a pivotal Phase III trial for non-small-cell lung cancer. NOV-002 is a novel drug capable of modifying redox-based cell processes and represents a valuable tool for linking such processes to clinical endpoints in oncology patients.

• Recordati SpA, of Milan, Italy, said it is acquiring pharmaceutical firm Orphan Europe, of Paris, for €135 million (US$192 million), which will be funded mostly from existing liquidity. The deal, subject to certain conditions, including clearance by the relevant anti-trust authorities, is expected to be completed before the end of 2007. Orphan Europe, a firm that develops treatments for rare and orphan diseases, reported 2006 sales of €40 million (US$59 million).

• Transdel Pharmaceuticals Inc., of La Jolla, Calif., completed a merger transaction for a public listing on the Over-the-Counter Bulletin Board, under the symbol "TDLP," and raised $4 million through the sale of common stock and warrants. The specialty pharmaceutical company, which develops and commercializes noninvasive, topically-targeted medications, intends to use the proceeds for further development of its lead drug, Ketotransdel, a topical cream nonsteroidal anti-inflammatory drug for pain. Following the merger and financings, Transdel has about 13.4 million shares outstanding.

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