• Agendia BV, of Amsterdam, the Netherlands, acquired the rights to the discovery of a mechanism of resistance to Herceptin (trastuzumab, Genentech Inc.), a frequently-used breast cancer drug. That discovery, recently published inCancer Cell, showed that biomarkers identified by Agendia have predictive value in patients treated with Herceptin to determine responsiveness and resistance.

• Alizyme plc, of Cambridge, UK, said it completed recruitment in the first Phase III pivotal efficacy study of Renzapride in treating irritable bowel syndrome, with headline results expected in April. The company has agreed on a special protocol assessment with the FDA for second Phase III pivotal efficacy study, with recruitment due to start in 2008. In addition, Alizyme said it is on track to complete recruitment in a 750-patient European Phase III study of Colal-Pred by the end of 2007. If the results are positive, that will support a marketing application in treating ulcerative colitis in the second half of next year. CEO Tim McCarthy said he is confident of sealing commercialization deals by the end of 2007.

• Antisoma plc, of London, said it received further data from its 74-patient randomized Phase II trial of ASA404 in hormone-refractory prostate cancer, which is comparing ASA404 plus docetaxel with docetaxel alone. Tumor response rates were higher in patients receiving ASA404, and time to disease progression was marginally longer. Median survival data are expected in the second half of 2008. The treatment was generally well tolerated.

• Apogenix GmbH, of Heidelberg, Germany, said a paper published by its scientific advisors in the October 2007 issue of Cell Stem Cell demonstrated that the combination of chemotherapy and IL-4 blockers can kill human cancer stem cells. Apogenix expects to begin clinical trials in 2010 with the lead candidate in its portfolio of IL-4 blockers.

• Argenta Discovery Ltd., of Harlow, UK, said it reached a milestone in its program with AstraZeneca plc, of London, to find improved bronchodilators for treating chronic obstructive pulmonary disease. Ten months after signing the deal, the team has nominated the first candidate drug to enter formal development triggering the undisclosed milestone payment. Scientists from the two companies are collaborating to identify long-acting muscarinic antagonists and dual-acting muscarinic antagonist-beta-2 agonist drugs.

• Ark Therapeutics Group plc, of London, has agreed to spin out discovery stage anti-angiogenic peptides and peptoid leads and associated data to Eyecopharm AG, of Hamburg, Germany, a newly formed company focused on eye diseases. Eyecopharm was founded by Heinrich Schulte, founder of Evotec AG and Endokrinologikum Medical, a medical care and diagnostics group in Germany. Ark receives 9 percent of Eyecopharm's equity and a single-digit royalty on future sales, and will hold a position on Eyecopharm's board. Ark's leads show specificity for the KDR and Neuropilin 1 receptors, which the company said will prevent angiogenesis without the risk of causing loss of vascular integrity in normal vessels.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, announced that its marketing authorization application (MAA) for alitretinoin submitted to various European Union member states was accepted for review under the decentralized procedure. The application supports the proposed use of oral alitretinoin in patients with severe refractory chronic hand eczema. The firm is seeking approval for oral alitretinoin for the treatment of severe refractory chronic hand eczema (CHE) and is based on a clinical program comprising almost 2,000 patients. Also, Basilea said Swissmedic has accepted for review, the marketing authorization application for oral alitretinoin in severe refractory chronic hand eczema. Other applications are under review in various European Union states.

• Bavarian Nordic AS, of Copenhagen, Denmark, has received an extension of an existing government contract to include the initiation of a larger Phase II study with Imvamune, the company's investigational smallpox vaccine, in persons diagnosed with atopic dermatitis. The extension, by the National Institute of Allergy and Infectious Diseases, will prolong the original contract to 2010 and has a value of $15 million, with the majority of revenue expected at the end of 2008 and beginning of 2009. The original contract, awarded in 2004 by NIAID, included a Phase II study in atopic dermatitis, but the need for more clinical safety data in that population has increased due to requirements from the FDA.

• Biofusion plc, of Sheffield, UK, divested two of its portfolio companies, Cardiff ProTides Ltd. and Cardiff Biologicals Ltd., in each of which Biofusion had a 50 percent share, to Morvus Technology Ltd., of Cardiff, UK, a privately owned cancer drug discovery and development specialist. Biofusion now owns 20 percent of Morvus. Morvus has raised more than £3.4 million (US$6.9 million) to date, and was valued at £12 million at the conclusion of its latest funding round in July 2007.

• BrainStorm Cell Therapeutics Inc., of Petach Tikvah, Israel, has named Rami Efrati CEO. Efrati is a former commander of technological and operational elite units and a retired colonel of the Israeli Defense Forces.

• Cellestis Ltd., of Melbourne, Australia, received FDA approval for its QuantiFERON-TB Gold In-Tube blood test for tuberculosis. The test is intended to replace the first-generation QuantiFERON-TB Gold blood test as well as the 100-year-old tuberculin skin test.

• Genfit, of Lille, France, initiated two Phase II clinical trials of GFT505, a drug candidate it is developing for the global treatment of risk factors associated with cardiometabolic diseases. In the first, the primary objectives are to evaluate the efficacy and tolerability of GFT505 in patients with Type IIb dyslipidemia, while the second will evaluate the drug in prediabetic patients with atherogenic dyslipidemia and abdominal obesity. The results of the two trials are expected in March and June. The drug is one of several Genfit has developed from its Selective Nuclear Receptor Modulator (SNuRM) platform and acts by triggering Peroxisome Proliferator-Activated Receptors (PPAR nuclear receptors) in the mechanisms regulating lipid and glucose metabolism. In animal models, GFT505 demonstrated significant positive effects on triglycerides, insulin resistance, HDL cholesterol and the prevention and stabilization of the atherosclerotic plaque.

• Genmab A/S, of Copenhagen, Denmark, amended its ongoing pivotal trial of HuMax-CD4 (zanolimumab) in refractory cutaneous T-cell lymphoma (CTCL) to include patients with Sezary syndrome. The company also discontinued dosing at 8 mg/kg in favor of 14 mg/kg, which has thus far shown higher response rates. Genmab also said it received orphan drug designation for refractory CTCL in Australia and for refractory nodal T-cell lymphoma in Europe. The drug already has orphan drug status for CTCL in the U.S. and Europe.

• Karo Bio AB, of Stockholm, Sweden, cut 14 staff positions in an effort to reorganize and focus on core programs. The move is estimated to save SEK20 million (US$3.1 million) annually. The company said it will focus internally on KB2115 for dyslipidemia, KB3305 for diabetes, and an additional program. Karo also has three programs funded by partners.

• Mimotopes Pty Ltd., of Melbourne, Australia, has entered into a licensing agreement with the Baker Heart Research Institute for jointly developed drug candidates targeting pulmonary arterial hypertension. As part of the licensing agreement, Mimotopes has assigned the intellectual property for a library of compounds to BHRI in return for a future milestone and/or licensing fees received by BHRI. Mimotopes also will contribute its medicinal chemistry expertise on a fee-for-service basis to assist in the clinical development of those compounds. Financial terms were not disclosed.

• NicOx SA, of Sophia-Antipolis, France, opened its new U.S. headquarters in Warren, NJ, where its commercial affairs and U.S. clinical operations departments are based. The U.S. office is headed by Sanjiv Sharma, who was appointed vice president of commercial affairs in April. The director of U.S. clinical operations is Joan Sutphen, who joined NicOx in February 2007.

• ValiRx plc, of London, has signed a full license agreement with Chroma Therapeutics, of Abingdon, UK, to commercialize a noninvasive diagnostic technology patent developed by Chroma that identifies epigenetic signal changes, in particular changes to the histone code, which occur in cancer-related illnesses. ValiRx said the technology, called Nucleosomics, has the potential to complement its own existing cancer diagnostics technology, HyperGenomics, to create a noninvasive, mass screening, cancer diagnostics package that can deliver early stage diagnosis, specific diagnosis, prognosis, evaluation and therapeutic strategy. Under the terms of the agreement, ValiRx will pay Chroma royalties on any future sales resulting from commercialization of the Nucleosomics technology.