• Advancis Pharmaceutical Corp., of Germantown, Md., has entered agreements under which Clonmel Healthcare Ltd., of Clonmel, Ireland, a subsidiary of Stada Arzneimittel AG, will provide Advancis with commercial supply of its Amoxicillin Pulsys products being evaluated in Phase III trials. Under the agreements, Advancis and Clonmel also have finalized an agreement for technology transfer, clinical/stability batches and commercial scale up and validation, as well as an agreement covering Advancis-funded facility build-out and equipment additions.

• AEterna Zentaris Inc., of Quebec, said positive results from a Phase I study of its oral growth hormone secretagogue, EP-1572, provided evidence that the compound is able to induce a significant rise in growth hormone levels. Potential applications include treatment for growth retardation in children and cachexia associated with chronic diseases such as AIDS and cancer.

• Agilent Technologies Inc., of Palo Alto, Calif., and Proteome Systems, of Sydney, Australia, signed a marketing agreement to collaborate on a solution for the analysis of glycoproteins. Proteome Systems will make its GlycomIQ software compatible with the Agilent XCT, XCT Plus and XCT Ultra ion trap mass spectrometers.

• Bioaccelerate Holdings Inc., of New York, appointed Frank Armstrong CEO. Armstrong previously served as chief operating officer. Former CEO and founder Lee Cole will remain chairman. Bioaccelerate focuses on acquiring, developing and commercializing pharmaceutical compounds and holds majority equity interests in 10 companies and minority interests in four others.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., presented new data Tuesday from a study of BioVant, the company's calcium phosphate (CaP) nanoparticle technology at the annual World Vaccine Congress in Montreal. The primary focus of the presentation was the intranasal mucosal surface delivery of an anthrax vaccine, and it highlighted the simultaneous immune-enhancement effects and non-injected vaccine delivery potential of CaP. The results confirm that data from earlier immunogenicity studies in mice still hold true in rabbits.

• CardioVascular BioTherapeutics Inc., of Henderson, Nev., announced it has concluded the conversion of $14.9 million of convertible notes into 5.8 million shares of common stock. CVBT focuses on developing drugs for cardiovascular diseases and its drug candidate, Cardio Vascu-Grow, is designed to facilitate the growth of new blood vessels in the heart and other tissues with an impaired vascular system.

• Cell Genesys Inc., of South San Francisco, said its scientists developed gene-expression technology that enables the production of full-length monoclonal antibodies at commercially relevant levels from a single-production cell line. The time required to develop cell lines can be significantly shortened from months to weeks. The technology employs adeno-associated viral or other viral-based genetic engineering and a genetic linkage.

• Chugai Pharmaceutical Co. Ltd., of Tokyo, reported that Forerunner Pharma Research Co. Ltd. was jointly established with Mitsui & Co. Ltd., of Tokyo. FPR, based in the Komaba Open Laboratory of the University of Tokyo Research Center for Advanced Science and Technology, is expected to deliver the ability to conduct drug exploration by integrating Chugai's drug development technologies with knowledge and information in universities and other research institutes.

• Compugen Ltd., of Tel Aviv, Israel, entered a joint pilot research project with Novartis AG, of Basel, Switzerland, in systems biology. Compugen will receive a one-time payment and generate information about biological interaction networks through the development of a platform for research and analysis of microarray and other biological data. Novartis will obtain sole rights to the specific results of the project, and Compugen will retain all rights to the research and discovery systems developed.

• ConjuChem Inc., of Montreal, said additional data from its Phase II trial of DAC:GLP-1 to treat Type II diabetes in combination with Metformin showed that the high-dose cohort demonstrated reduced HbA1c levels by 1.01 percent, compared to placebo. Fifty-eight percent of patients who completed treatment in the cohort and whose entry-level HbA1c was greater than 7 percent had their HbA1c reduced to 7 percent or less. The company also said an ongoing Phase I trial has identified a lead diluent for DAC:GLP-1 that improves tolerability and enhances stability.

• Corcept Therapeutics Inc., of Menlo Park, Calif., said results from two preclinical studies show that Corlux has the potential to reduce the weight gain caused by olanzapine and to prevent the weight gain caused by the initiation of treatment with olanzapine. In each of the studies, rats were allowed to eat a normal diet. Rats that received the combination of olanzapine and Corlus gained significantly less weight than rats fed olanzapine plus placebo.

• CytRx Corp., of Los Angeles, completed a meeting with representatives of the FDA prior to the submission of an investigational new drug application for the company's lead small-molecule candidate, arimoclomol, to treat amyotrophic lateral sclerosis. The company plans to file an investigational new drug application and begin a Phase II trial this quarter.

• Eximias Pharmaceutical Corp., of Berwyn, Pa., completed enrollment in its pivotal Phase III study with Thymitaq in patients with inoperable primary liver cancer. The ETHECC trial is comparing survival of patients with inoperable primary liver cancer treated with Thymitaq to patients treated with doxorubicin. Thymitaq is a high-affinity antifolate designed to inhibit thymidylate synthase and disrupt DNA replication.

• GeneGo Inc., of St. Joseph, Mich., said that NV Organon, of Oss, the Netherlands, licensed MetaCore, GeneGo's platform for mining high-throughput experimental data in the context of biological networks and human diseases. Financial terms were not disclosed.

• Halozyme Therapeutics Inc., of San Diego, said preclinical data of PH20 hyaluronidase enzyme were presented at the 2005 American Society of Cataract & Refractive Surgery Symposium in Washington. When viscoelastic agents commonly used in cataract surgery were placed in the eyes of animals, injection of recombinant human PH20 enzyme into the front of the eye significantly reduced the incidence and severity of intraocular pressure rises. Halozyme's hyaluronidase is being investigated for its ability to break down hyaluronic acid. In other news, Halozyme received 510(k) clearance from the FDA for Cumulase for the treatment of oocytes to facilitate certain in vitro fertilization procedures.

• Icoria Inc., of Research Triangle Park, N.C., said it will use its methodologies to characterize Admet Technologies Inc.'s human adult hepatocytes to improve their value as a predictive toxicology screening tool in the early stages of drug development. Under the agreement, Admet will provide Icoria with liver cells from patients with a diversity of clinical conditions, such as fatty-liver disease and diabetes, and Icoria will use its metabolomics, gene-expression and pathway analysis technologies to develop biological profiles and correlate those with differing sensitivities to various classes of known hepatotoxic drugs. Icoria will retain rights to commercial development of any novel diagnostic biomarkers that are discovered.

• Medicure Inc., of Winnipeg, Manitoba, said it has received a recommendation to continue its Phase II/III MEND-CABG trial following a meeting of the independent Data Safety Monitoring Board. The recommendation is based on the recent review of safety data in the majority of patients who have completed 30 days of treatment following coronary artery bypass graft surgery. Medicure said the trial is evaluating the cardioprotective and neuroprotective effects of MC-1 in patients undergoing high-risk surgery.

• RheoGene Inc., of Norristown, Pa., and TissueGene Inc., of Gaithersburg, Md., entered a collaborative research and licensing agreement to develop regulated cell therapy treatments for bone restoration and repair. The companies will combine TissueGene's cell therapy technology and RheoGene's RheoSwitch Therapeutic System to develop nonsurgical treatments for non-union bone fracture, non-healing bone wounds and osteoporosis. The companies will assess the utility of the RheoSwitch Therapeutic System.

• SkyePharma plc, of London, entered a potential $80 million development and marketing arrangement with Cambridge, UK-based Mundipharma International Holdings Ltd. for the marketing and distribution of DepoVupivacaine in Europe and other international markets, excluding the U.S., Canada and Japan. SkyePharma will receive $10 million on signature, most of which will be deferred to cover the cost of the Phase II trial, and also receive further contributions of up to $20 million toward the cost of the Phase III trials. Additional milestone payments for development goals, marketing approvals and sales targets could amount to more than $80 million.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., and its co-development partner for satraplatin, GPC Biotech AG, of Martinsried, Germany, said an independent Data Monitoring Board reviewed safety data from the 262 patients in a Phase III trial and recommended that the trial continue as planned. Satraplatin, an orally bioavailable platinum-based drug, is being studied as a second-line treatment for hormone-refractory prostate cancer. Patient enrollment is scheduled to be complete by the end of the year, and a new drug application should be submitted in the second half of 2006.

• Synbiotics Corp., of San Diego, said it will seek shareholder approval to go private, proposing a 1-for-2,000 reverse split of its common stock, with a payment in lieu of issuing fractional shares, followed by a 2,000-for-1 forward split of its common stock. The cash payment will be at the rate of $0.13 per pre-reverse split share traceable to the fractional shares. Synbiotics would de-register as soon as possible, in order to cut costs.

• Tercica Inc., of South San Francisco, said the U.S. District Court for the Northern District of California denied a motion by Insmed Inc., of Richmond, Va., that a summary judgment be made in Insmed's favor concerning the patent-infringement suit over the U.S. commercialization of SomatoKine for growth hormone-insensitivity syndrome. The court granted Insmed's motion to dismiss the plaintiff's complaint as originally written, allowing Tercica and Genentech Inc., also of South San Francisco, 30 days to resubmit it.

• The Immune Response Corp., of Carlsbad, Calif., said a preclinical study demonstrated the potential for a gp120-deleted HIV-1 antigen (a component of Remune) with a CpG oligonucleotide adjuvant to have a protective role when administered to Trimera mice prior to HIV infection. Results of the study were published in the FASKB Journal online April 15, 2005. The company is planning a study with the same components of IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant, using this model.

• The National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., said it closed a randomized trial comparing Iressa (gefitinib) vs. placebo following chemotherapy and radiation for patients with non-small-cell lung cancer that had spread only to nearby tissues or lymph nodes. NCI reported that Phase III interim data indicated that Iressa, a drug designed to inhibit tyrosine kinase, could not improve patient survival. Iressa was developed by London-based AstraZeneca plc. Detailed results from the study are expected to be presented during the American Society of Clinical Oncology meeting in May.

• URL/Mutual Pharmaceutical Co., of Philadelphia, and Collegium Pharmaceutical Inc., of Cumberland, R.I., entered a product development agreement for the development and commercialization of an undisclosed product. Collegium is responsible for all aspects of formulation, process and analytical development, as well as manufacturing, and will be paid certain milestones and royalties. URL/Mutual will handle pivotal bioavailability, commercial manufacturing and commercialization of the product and will be responsible for all required regulatory filings. The companies expect that the product will be available for launch in late 2006 or early 2007.

• Vical Inc., of San Diego, said initial human testing of a vaccine targeting West Nile virus began at the National Institutes of Health's clinical center in Bethesda, Md. The vaccine is based on Vical's DNA delivery technology, which was co-developed with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center. The trial will enroll 15 healthy adult volunteers, who each will receive three injections of the vaccine at four-week intervals.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said the Phase I single-agent trial of its cancer agent Cloretazine in acute myeloid leukemia and high-risk myelodysplastic syndromes has been closed to new patient accrual. The trial has enrolled more than 154 patients. The company recently initiated a randomized, placebo-controlled Phase III trial of Cloretazine in combination with Ara-C in patients with AML.