• Amarin Corp. plc, of London, appointed Thomas Lynch, board chairman, as CEO, replacing Rick Stewart, who resigned. Additionally, Chief Financial Officer Alan Cooke was promoted to president and chief operating officer. The company also completed its previously announced $8.1 million financing and related acquisition of privately held mRNA company Ester Neurosciences Ltd.
• Antisoma plc, of London, opened its new U.S. headquarters in Princeton, N.J. The facility will focus on clinical and regulatory development and will be led by Chris Smyth, vice president of U.S. operations and former head of clinical operations for Antisoma.
• Axentis Pharma AG, of Zurich, Switzerland, said it has gained exclusive licensing rights from aRigen Pharmaceuticals Inc., of Japan, to develop and commercialize ARB-CF0223, a drug delivery system for lung infections in patients with cystic fibrosis, in nations outside Korea and Japan. The system reduces the frequency and severity of exacerbations compared with current treatments for pulmonary infections in patients with CF, according to the firms. As part of the agreement, aRigen received shares of Axentis plus an undisclosed sum in cash. Axentis said it plans to immediately start a Phase II clinical trial of the compound in Germany. The design of the study has already been approved by the European Medicines Agency, which also granted orphan drug status to ARB-CF0223.
• Bavarian Nordic AS, of Kvistgard, Denmark, said it received another milestone payment of $25 million under its contract with the U.S. government to manufacture and deliver 20 million doses of the company's Imvamune smallpox vaccine. The income will be recognized as revenue in the financial statements for 2007. The payment brings to date a total of $100 million for the firm in milestone payments under the contract.
• BioLineRx Ltd., of Jerusalem, said that preclinical trial data demonstrated that BL-2030, a soluble chemokine receptor 2 for the treatment of prostate cancer, was effective in significantly reducing tumor growth and preventing metastasis to the lungs and bones of treated mice. The firm said it plans to start its clinical trial program for the compound in 2008. In addition, the company noted that it is completing a Phase IIa clinical study of its schizophrenia compound BL-1020 and is scheduled to start a clinical trial in early 2008 for BL-1040 in acute myocardial infarction. BioLineRx also anticipates starting clinical trials next year for BL-1021 for the treatment of pain and BL-4010 for solid tumors, which would expand the firm's clinical pipeline to five therapeutic candidates in 2008.
• Cancer Therapeutics CRC Pty Ltd., of Melbourne, Australia, and the Queensland Institute of Medical Research said they are collaborating to discover and develop new drugs to treat a variety of cancers based on the discovery of a new protein target that is critical to the genetic repair processes that promote cancer cell survival and keep them replicating.
• Celltrion Inc., of Incheon, South Korea, said the FDA cleared the company to serve as a contract manufacturer to produce Orencia (abatacept) for rheumatoid arthritis, developed by Bristol-Myers Squibb Co., of New York. The supplemental biological license application was submitted by BMS to meet expected long-term demand.
• Compugen Ltd., of Tel Aviv, Israel, has signed a collaborative discovery and license agreement with Roche AG, of Basel, Switzerland, that will cover the identification and validation of genetic variations for the prediction of response to drugs used for the treatment of rheumatoid arthritis. Under the agreement, Compugen, utilizing its GeneVa platform, will analyze DNA samples and clinical data provided by Roche to identify and validate nonsingle nucleotide polymorphism genetic variations that could serve as biomarkers for the predicted response or nonresponse to selected drugs. Financial terms of the agreement were not disclosed.
• Crucell NV, of Leiden, the Netherlands, and DSM Pharmaceutical Products, of Parsippany, N.J., granted licensing rights for their PER.C6 cell line to Medarex Inc., of Princeton, N.J. The license agreement allows Medarex to use PER.C6 in its antibody research. Financial terms were not disclosed.
• DiaGenic ASA, of Oslo, Norway, said the Michael J. Fox Foundation for Parkinson's Research is funding a DiaGenic study to develop the first blood test for Parkinson's disease: a gene expression signature for the early detection of PD. That involves the identification and validation of a unique gene expression signature for Parkinson's using peripheral blood. The work will be done in conjunction with the Harvard PD Biomarker Study, which is designed for discovery and validation of blood tests for Parkinson's disease.
• Evogene Ltd., of Rehovot, Israel, reported successful third-year field trial results for Evo133, one of its candidate genes for improving plant yield and tolerance to abiotic stress conditions. Transgenic tomato plants overexpressing Evo133 demonstrated an increase of up to 25 percent under normal conditions and up to 20 percent under abiotic stress conditions compared to control plants. Those results are consistent with two previous field trials conducted in 2005 and 2006.
• Flamel Technologies, of Lyon, France, said it has entered into a collaboration with Merck Serono, of Geneva, to investigate the applicability of Flamel's Medusa technology for the extended release of a therapeutic protein of Merck Serono's portfolio. Under the terms of the agreement, Merck Serono will make an up-front payment of €2 million (US$2.86 million) to Flamel for investigating the therapeutic protein. In addition, Merck Serono will fund R&D efforts to be performed at Flamel. Other financial terms of the agreement were not disclosed.
• LifeCycle Pharma A/S, of Horsholm, Denmark, signed a collaboration agreement for an undisclosed pharma firm to use its MeltDose technology to conduct a preclinical feasibility study of a new formulation of one of its product candidates. Financial terms were not disclosed.
• Lytix Biopharma, of Tromso, Norway, has completed a private placement of NOK50 million (US$8.9 million). The placement was heavily oversubscribed by Norwegian institutional and private investors and will be used to fund the two areas of the company's business - antimicrobials and cancer therapeutics. Lytix specializes in micro-sized synthetic peptides offering rapid and selective cell lysis and a follow-on vaccination effect.
• Nanolymf, of Jerusalem, was spun out from Yissum Ltd., the technology transfer arm of Hebrew University of Jerusalem. The new company will develop a nanotechnology-based, controlled-release delivery platform for lipophilic drugs. Nanolymf, a subsidiary of Rosh Ha'Ayin-based conglomerate Shizim Ltd., has raised $500,000 and is seeking an additional $2 million to fund clinical trials.
• Stealth Biotech Aps, of Copenhagen, Denmark, has filed fundamental patent applications covering methods and products used for blocking specific microRNA:mRNA interactions, a novel approach using antisense molecules that target microRNA binding sites on mRNAs. The filing is part of the firm's plans to target specific microRNA:mRNA interactions for development of novel oligonucleotide-based therapeutics.
• Virax Holdings Ltd., of Melbourne, Australia, is raising A$2.7 million (US$2.3 million) through the issuance of convertible notes. The firm also appointed Larry Ward CEO. Virax develops immunotherapeutic products in cancer and chronic infectious diseases, and recently was cleared by the FDA to start Phase II testing of its lead product, VIR201, a therapeutic vaccine against HIV/AIDS.