Abmaxis Inc., of Santa Clara, Calif., and MaimoniDex RA Ltd., of Jerusalem, signed an agreement to jointly develop a therapeutic human monoclonal antibody for the treatment of rheumatoid arthritis and other inflammatory diseases. Based on its discovery of a disease-causing molecule found only in the joints of RA patients, MaimoniDex has developed a murine monoclonal antibody that has shown bioactivities both in vitro and in vivo. Abmaxis will humanize and optimize the murine antibody to develop a drug suitable for therapeutic use. MaimoniDex will pay Abmaxis an up-front technology license fee and Abmaxis also is entitled to receive future milestone payments and royalties.

• Acambis plc, of Cambridge, UK, after a 30-day review period of a complaint, is the subject of an investigation by the U.S. International Trade Commission in Washington. The investigation relates to alleged patent infringement on MVA smallpox vaccine products marketed by Acambis plc, and the complaint was filed by Bavarian Nordic A/S, of Copenhagen, Denmark, stating that Acambis imported and sold, and/or offered to sell in the U.S., MVA smallpox vaccines that infringe patents owned by Bavarian Nordic. The complaint further alleges misappropriation of Bavarian Nordic's MVA-BN proprietary technology. Bavarian Nordic is requesting the ITC to issue a permanent cease and desist order, which would prohibit Acambis from importing, selling or offering for sale in the U.S. its MVA smallpox vaccine or other products that infringe Bavarian Nordic's patents. The firms are involved in a bidding process to supply doses of MVA smallpox vaccine products to the U.S. Department of Health and Human Services under the BioShield program.

• Aegera Therapeutics Inc., of Montreal, initiated its second Phase I trial for AEG35156 in combination with Taxotere (docetaxel) in patients with solid tumors. The product is a second-generation XIAP antisense therapeutic. The multicenter trial, which aims to determine the recommended Phase II dose of AEG35156, is being coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queen's University.

• Affymax Inc., of Palo Alto, Calif., initiated a third Phase II trial of Hematide, a synthetic, peptide-based erythropoiesis-stimulating agent that is being developed to stimulate production of red blood cells to treat anemia in patients with kidney disease and cancer. The study is a multicenter, open-label, dose-finding trial that will evaluate repeat, subcutaneous injections of Hematide to correct anemia and maintain target levels of hemoglobin in patients with chronic kidney disease who are not on dialysis and have not been treated previously with erythropoietin.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., completed enrollment in its Phase III trial of eculizumab in patients with the chronic orphan blood disorder paroxysmal nocturnal hemoglobinuria. Called SHEPHERD, it is the second of two studies comprising the overall pivotal program in that indication. About 95 patients have been enrolled, exceeding the company's objective for the open-label trial that includes 12 months of treatment and a six-month interim analysis. Eculizumab is a monoclonal antibody designed to block the terminal complement part of the immune system.

• Amarin Corp., of London, said patient enrollment and first dosing began in the U.S. Phase III trial of Miraxion in Huntington's disease by The Huntington Study Group. The company expects to begin a European trial later in the year. The Miraxion Phase III trials are being conducted under a special protocol assessment procedure approved by the FDA.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., extended its manufacturing agreement with DPT Laboratories for the manufacture of Testim through 2010. The existing agreement was set to expire Dec. 31. Testim is a topical testosterone gel to treat hypogonadism. DPT has manufacturing facilities in San Antonio, Texas, and Lakewood, N.J.

• Avantogen Ltd., of Sydney, Australia, and Innovate Oncology Inc., of New York, said pancreatic cancer results on RP101 reported at the International Conference on Tumor Progression and Therapeutic Resistance in Burlington Mass., showed that the product extends survival beyond previous results of RP101 co-administered with standard chemotherapy. The new data showed that 10 of 13 original patients survived at least one year following treatment; median survival was 447 days. Time to progression was 280 days, and presently, four of the original 13 remain alive for nearly two years. Avantogen, formerly called Australian Cancer Technology, and Innovate have jointly licensed RP101 from RESprotect GmbH, of Dresden, Germany, and plan to sponsor clinical trials in the U.S. starting early next year.

• Avitar Inc., of Canton, Mass., received approval to list its common stock on the Over-the-Counter Bulletin Board under the symbol "AVRN." Avitar develops, manufactures and markets products for the oral fluid diagnostic market, the disease and clinical testing market, and customized polyurethane applications used in the wound dressing industry.

• Bioenvision Inc., of New York, enrolled its first seven patients in a Phase IV study in the UK of Modrenal in post-menopausal women with advanced breast cancer who have failed prior endocrine therapy with the new generation of aromatase inhibitors. Modrenal is licensed in the UK to treat post-menopausal advanced breast cancer following relapse on prior therapy and has demonstrated clinical benefit rates up to 55 percent.

• Cellectis SA, of Romainville, France, entered a research collaboration and license agreement with Biogen Idec Inc., of Cambridge, Mass., to develop a custom Meganuclease Recombination System designed to enable reproducible high-yield production of target proteins in mammalian cells. Cellectis will engineer a meganuclease and DNA targeting matrix to induce site-specific homologous recombination. Financial terms were not disclosed.

• Cephalon Inc., of Frazer, Pa., and Alkermes Inc., of Cambridge, Mass., received notification from the FDA that the PDUFA date for Vivitrex, a naltrexone long-action injection for the treatment of alcohol dependence was extended to Dec. 30. The companies anticipate launching Vivitrex in the first half of 2006. The extension is a result of the FDA classifying a recent response by Alkermes as a major amendment to the NDA, which permits the FDA to extend the action date by 90 days under PDUFA regulations.

• Ceregene Inc., of San Diego, began a Phase I study of CERE-120 to treat Parkinson's disease. The product is a gene therapy that delivers the neurturin (NTN) gene via an adeno-associated virus Type II vector delivery system, and the company owns exclusive technology and product rights to it. The naturally occurring NTN gene encodes the NTN protein that maintains survival of dopamine-producing nerve cells that are required for normal bodily movement and are the nerves that degenerate in Parkinson's disease patients.

• CuraGen Corp., of New Haven, Conn., said that during August and September, the company repurchased $23.9 million of face value of its 6 percent convertible subordinated notes due February 2007. The aggregate purchase price for the face value of the 2007 notes was $23.8 million. CuraGen is focused on protein, antibody and small-molecule therapeutics in the areas of oncology, inflammatory diseases and diabetes.

• Dendreon Corp., of Seattle, presented new data showing that modulation of the Trp-p8 tumor target with small molecules might represent a new approach to cancer therapy. Also, the company has identified several lead candidates for future clinical study that are orally bioavailable and agonists of Trp-p8, it said. The data were presented at the Ion Channel Targets Conference in Waltham, Mass. Trp-p8 is normally expressed in the prostate and overexpressed in numerous cancers.

• Diosynth Biotechnology, of Research Triangle Park, N.C., agreed to an amendment of the current agreement it has with NeoPharm Inc., of Lake Forest, Ill. Under the amendment, Diosynth will perform validation and conformance lot manufacturing of NeoPharm's IL 13-PE38QQR (cintredekin besudotox) drug candidate if NeoPharm is able to move forward with a biologic license application once it completes its pivotal Phase III trial for glioblastoma multiforme.

• Elan Corp plc., of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., expect the safety evaluation of Tysabri in Crohn's disease and rheumatoid arthritis will be completed in the coming weeks. It also said it would submit a supplemental biologics license application for Tysabri in multiple sclerosis to the FDA. In February, the companies had suspended ongoing clinical trials based on three reports of multifocal leukoencephalopathy or PML, a demyelinating disease of the central nervous system. A previous safety evaluation of Tysabri to treat multiple sclerosis did not show any new confirmed cases of PML. (See BioWorld Today, March 1, 2005.)

• Genaera Corp., of Plymouth, Pa., started its pivotal Phase II trial for the mucoregulator drug, Lomucin, in people with cystic fibrosis. Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, is supporting the pivotal trial with funding of up to $2.35 million in milestone-driven matching funds. The study, which will be initiated in Ireland, will evaluate Lomucin in 200 cystic fibrosis patients.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered a pharmacogenomic research collaboration with Otsuka Pharmaceutical Co. Ltd., of Tokyo. Terms of the deal call for Genaissance to apply its HAP Technology to identify genetic markers related to drug response. Both companies will jointly own resulting intellectual property, and both will be eligible to receive royalties.

• Gentium SpA, of Villa Guardia, Italy, is beginning an independent Phase I/II study at 10 cancer centers in Italy of Defibrotide to treat multiple myeloma. The study is a Phase I/II study designed to assess the safety and the efficacy of Defibrotide with MPT regimen as a salvage treatment in advanced refractory multiple myeloma patients. Defibrotide is a single-stranded DNA that protects the vascular endothelial cells, particularly those of small vessels, from damage and activation, Gentium said.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, received about C$3.4 million (US$2.9 million) from the restructuring of one of its wholly owned subsidiaries that will be used to fund operations until the end of 2007. Inflazyme also entered a put agreement that assures the ability to sell its holdings in the subsidiary for an additional C$2.5 million, an option exercisable upon the satisfaction of certain conditions or in any event on March 15, 2006. Inflazyme expects to realize the additional money before then, it said.

• Institute of Systems Biology in Seattle, and Kreatech Biotechnology, of Amsterdam, the Netherlands, have formed an arrangement between Kreatech and the institute for the use of its commercial products. Kreatech's platinum based "Universal Linkage System" (ULS), a non-enzymatic way of labeling nucleic acids with detectable molecules such as fluorophores, has been adopted by a research group and now is the preferred labeling method for both bacterial gene expression profiling and chip on chip assays that have been developed at the ISB.

• Large Scale Biology Corp., of Vacaville, Calif., and Icon Genetics AG, of Munich, Germany, completed the research phase of their collaborative program to co-develop a biopharmaceutical product for enzyme-replacement therapy and began its commercial phase. They had been working to apply their gene expression and biomanufacturing resources for such a product, by way of their plant-based platforms. Future details of the agreement were not disclosed.

Laureate Pharma Inc., of Princeton, N.J., and Enobia Pharma Inc., of Montreal, entered an agreement for process development and manufacture of cGMP batches of Enobia's recombinant enzyme sPHEX Metallo Peptidase. Also, Laureate Pharma expects to supply Enobia with material for Phase I trials in the third quarter of 2006. Terms of the agreement were not disclosed.

• Medicure Inc., of Winnipeg, Manitoba, said the FDA has granted Medicure's cardioprotective drug, MC-1, fast-track designation as a treatment to reduce cardiovascular and cerebrovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions, coronary artery bypass graft surgery and acute coronary syndrome. MC-1 is a naturally occurring small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury.

• MicroIslet Inc., of San Diego, said the American Stock Exchange accepted its plan to regain compliance with listing requirements after failing to file its Form 10-QSB for the period ended June 30. The listing is being continued pursuant to an extension predicated on the company being in compliance with all continued listing standards by Oct. 6. MicroIslet said it has been unable to file the form due to a continuing analysis of its accounting for warrants issued to service providers last year.

• Millenium Biologix Corp., of Kingston, Ontario, said at the Eurospine 2005 Congress in Barcelona that the European commercial launch of Primacoll has occurred. Primacoll is a synthetically manufactured bioactive peptide that is combined with Skelite, Millenium's synthetic bone graft substitute. That combination has shown to be effective in the initial stages of bone repair, it said. The commercialization of Primacoll will be handled by Millenium's European distributors.

• NitroMed Inc., of Lexington, Mass., reported new data at the annual meeting of the Heart Failure Society of America held in Boca Raton, Fla. The data, which were co-sponsored by NitroMed and the Association of Black Cardiologists, suggest that BiDil (isosorbide dinitrate/hydralazine hydrochloride) can inhibit left ventricular remodeling in patients with severe heart failure. Echocardiograms from 678 patients performed at both baseline and at six months were analyzed for specific cardiac parameters.

• OrthoLogic Corp., of Tempe, Ariz., said the online version of Journal of Cellular Physiology published findings that Chrysalin accelerates the growth of new blood vessels that have already sprouted, which can be an advantage for bone and tissue repair. Preclinical studies have shown that Chrysalin stimulates wound repair and fracture healing, and that the response is associated with enhanced growth of new blood vessels. The new study examined more closely the mechanism by which Chrysalin stimulates neovascularization.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said Tarceva (erlotinib) received European approval for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen. The approval is based on data from a pivotal Phase III study, recently published in The New England Journal of Medicine, which compared Tarceva to placebo in treating lung cancer patients following failure of first- or second-line chemotherapy. As with previous U.S., Swiss and Canadian approvals, no mandatory testing for epidermal growth factor receptor (EGFR) is required. The latest approval was handled by OSI's international partner, F. Hoffmann-La Roche Ltd., of Basel, Switzerland.

• Oxigene Inc., of Waltham, Mass., started a Phase II trial of Combretastatin A4 Phosphate (CA4P) in triple combination therapy with carboplatin and paclitaxel to treat relapsed, advanced platinum-resistant ovarian cancer. The trial will be an international, open-label trial designed to determine the safety and efficacy of CA4P in combination with the other therapies. It will be initiated at cancer centers in the UK and the U.S.

• OXIS International Inc., of Portland, Ore., which focuses on developing technologies for the diagnosis of diseases resulting from oxidative stress, and BioCheck Inc., of Foster City, Calif. a producer of enzyme immunoassay research kits, entered a definitive agreement for OXIS to acquire up to all of the outstanding capital stock of BioCheck for an aggregate purchase price of up to $6 million in cash, subject to approval by BioCheck's stockholders. BioCheck would become a subsidiary of OXIS.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., presented preclinical data on its investigational compound, PPI-2458, at the Cambridge Healthtech Institute's Inaugural Targeted Cancer Therapies Conference held in Cambridge, Mass. PPI-2458 is a molecule belonging to the fumagillin class of compounds that specifically targets the MetAP-2 enzyme. That class of compounds has been shown to prevent both abnormal cell growth and the formation of new blood vessels.

• QLT Inc., of Vancouver, British Columbia, said that preliminary analysis of the intent-to-treat population of the Visudyne in Occult (VIO) trial did not achieve the primary endpoint at the two-year time point. VIO is part of a broader series of trials conducted with Visudyne in patients with predominantly occult CNV. Two earlier trials have previously demonstrated evidence of efficacy in this patient population. The company is still conducting further analyses on relevant subgroups. The results of the full efficacy and safety analyses together with the combined evidence from the three trials will be discussed in the upcoming meeting of the Data and Safety monitoring committee (DSMC) and in advisory boards. QLT's stock (NASDAQ:QLTI) lost $1.09 Wednesday, or 13.1 percent, to close at $7.22.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., filed a citizens' petition with the FDA requesting that no abbreviated new drug applications be approved for generic oral products containing oxandrolone prior to the expiration of the company's exclusive labeling for geriatric dosing on June 20, 2008. The FDA's guidance on geriatric labeling requires that ANDA's contain the same geriatric labeling as the Reference Listed Drug.

• The University of Gottingen in Germany said results of a five-year study showed that colorectal cancer patients treated after surgery with one injection of a 131l-labeled labetuxumab antibody, developed by Immunomedics Inc., of Morris Plains, N.J., survived twice as long as either historical controls or a contemporaneous control group of patients receiving either chemotherapy or no therapy. The data were published in a recent issue of The Journal of Clinical Oncology. Involved were 23 patients who had complete resection of their liver metastases. Patients that received the Immunomedics antibody had a 68-month median survival, compared to patients receiving either chemotherapy or no therapy who had a 31-month median survival.

• Transgene SA, of Strasbourg, France, voluntarily delisted its American depository shares from the Nasdaq market due to their low trading volume and the growing costs of a dual listing with shares also on the Paris Eurolist markets. They represented less than 1 percent of the company's share capital at the end of last month, it said.

• XTL Biopharmaceuticals Ltd., of Rehovot, Israel, closed its license and asset purchase agreement with VivoQuest Inc., of Valley Cottage, N.Y., giving XTL an exclusive license to VivoQuest's intellectual property and technology, including hepatitis C virus compounds and VivoQuest's compound library. Also XTL made a $1.4 million up-front payment by way of issuing about 1.3 million shares. All other amounts to be paid to VivoQuest will be subject to the achievement of certain milestones. Also, members of the VivoQuest's U.S.-based research and development team joined XTL, along with a pair of scientific advisers.

• Zen-Bio Inc., of Research Triangle Park, N.C., received a 24-month $961,578 Phase II Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The grant will be used to fund the development and characterization of a human omental adipocyte cell system. Customers will be able to use the system to evaluate potential new drugs and therapies, and to elucidate some basic functions of the highly metabolically active endocrine organ, it said.

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