• Accelrys Inc., of San Diego, and the University of Cambridge in the UK signed two exclusive agreements in which Accelrys will provide researchers with a method to aid the characterization of molecular-level structure. Accelrys will deliver the materials science software, developed in the university, directly to its customers in industrial research.

• Anadys Pharmaceuticals Inc., of San Diego, reported new data from the completed Phase Ib trial of isatoribine (ANA245) at the American Association for the Study of Liver Diseases' annual meeting in Boston. Results showed isatoribine was safe, well tolerated and biologically active. They also demonstrated a statistically significant viral load reduction in the plasma of patients chronically infected with hepatitis C virus.

• Ardent Pharmaceuticals Inc., of Durham, Calif., entered an option and license agreement with ALZA Corp., of Mountain View, Calif., for the development of DPI-125 for moderate to severe pain. In consideration of an initial fee payable upon signing, Ardent granted ALZA a 12-month option for an exclusive, worldwide license to the compound. During that period, ALZA will conduct feasibility studies and, if it exercises the option, will proceed with development of at least two potential products: an intravenous formulation for acute pain and at least one formulation for chronic pain. ALZA also could elect to develop other formulations of DPI-125, and it has exclusive options to license additional analgesic compounds from the Ardent portfolio. Development and commercialization expenses for the products will be borne by ALZA. Ardent would receive further payments should ALZA exercise its option following feasibility studies, and also would be eligible for development milestone payments and royalties. Ardent also would obtain the right to co-promote the intravenous product in the U.S. Ardent recently entered an agreement to merge with Enhance Biotech Inc., of New York.

• Chemicon International Inc., of Atlanta, a division of Serologicals Corp., said it will acquire the material assets related to two mouse embryonic stem cell product lines from Primogenix Inc., of St. Louis. The acquisition will add novel strains of mouse embryonic stem cells to Chemicon's stem cell product portfolio. Primogenix has demonstrated the application and benefits of the PRX-129S6 and PRX-C57BL/6 tyr c-2J albino lines for the generation of mice that have specific genetic alterations.

• Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, said Mathew Vadas will be interim CEO, subject to release by the Institute for Medical and Veterinary Science in Adelaide. Vadas is the company's chief scientific adviser and chairman of its scientific advisory board. Cryptome focuses on the discovery and development of protein-derived medicines targeting cancer and cardiovascular disease.

• Dendreon Corp., of Seattle, succeeded in reproducing the antigen used in the preparation of Provenge, its investigational immunotherapy for prostate cancer, at commercial manufacturing scale. The company achieved the milestone with its contract manufacturer, Diosynth Biotechnology, of Morrisville, N.C., a unit of Akzo Nobel. Provenge is in Phase III work for prostate cancer.

• Generex Biotechnology Corp., of Toronto, said it is developing its oral glucose spray formulation, GlucoSpray, for delivery by way of its RapidMist device. Initial research efforts have shown that the system produces glucose in the blood within five minutes.

• Genzyme Corp., of Cambridge, Mass., submitted a new drug application supplement to the FDA to obtain an additional clinical indication for Thyrogen (thyrotropin alfa for injection). The new indication would permit the product's use in the ablation of remnant thyroid tissue. Genzyme also is seeking to add the indication to the product's European label. Thyrogen is indicated for use as a diagnostic tool in the management of the recurrence of well-differentiated thyroid cancer.

• IMI International Medical Innovations Inc., of Toronto, made an unsolicited offer to acquire all of the outstanding common shares of Ibex Technologies Inc., of Montreal. Ibex is focused on using molecular biomarkers for the management of cancer and arthritis. Ibex shareholders can elect to receive 0.1254 common shares of IMI, or 42 cents in cash, for each Ibex share owned. If all Ibex shares are tendered, IMI would issue about 2 million shares and pay about $2.2 million in cash. IMI's shares (AMEX:IME) rose 6 cents Wednesday to close at $2.73.

• ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., raised about $2.5 million in equity funding with Joseph Stevens & Co. Inc. The capital is slated to be used in the ongoing development of Homspera, the company's compound for improving pulmonary function and stimulating the human immune system. Also, the capital will fund the initiation and completion of the company's final study on the treatment of acute radiation sickness. ImmuneRegen is a wholly owned subsidiary of IR BioSciences Holdings Inc.

• The Institute for Systems Biology in Seattle, in collaboration with researchers from National Yan Ming University in Taiwan and University of Texas at Austin, published findings in this month's issue of Genome Research detailing their efforts in fully sequencing the complete genome of Haloarcula marismortui, a microorganism that thrives in the Dead Sea.

• InterMune Inc., of Boston, presented clinical findings on Infergen used in combination with ribavirin to treat hepatitis C at the 55th annual meeting of the American Association for the Study of Liver Diseases held in Boston. The results indicate a consistent pattern of efficacy and safety. Researchers looked at African-Americans and non-African-Americans who have failed to respond to pegylated interferon-alpha-2 plus ribavirin therapy. A sustained virologic response of 27 percent was achieved in the African-American patient group. In all patients, the SVR was 37 percent.

• Isotechnika Inc., of Edmonton, Alberta, completed the multiple-ascending dose study for its lead immunosuppressive drug, ISA247, that began on June 3 and involved 43 subjects. The study achieved all safety endpoints. At anticipated therapeutic doses for psoriasis treatment, subjects experienced no clinical significant impact on renal function as measured either by serum creatinine or 24-hour creatinine-clearance determinations.

• Microscience Ltd., of Wokingham, UK, reported results from a Phase I trial of its spi-VECTM oral immunotherapeutic vaccine designed for the treatment of chronic hepatitis B infection. The trial met its primary objectives and demonstrated safety and immunogenicity. The immunological data demonstrated that all subjects mounted a T-cell-proliferative response to both the HBcAg and to groups of peptides representing the whole sequence of HBcAg.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the FDA granted Velcade fast-track designation for relapsed and refractory mantle-cell lymphoma. The product is being evaluated as a single agent in a multicenter Phase II trial for the treatment of mantle-cell lymphoma, in addition to other trials that are part of an ongoing research collaboration between Millennium and Johnson & Johnson Pharmaceutical Research and Development LLC. Velcade is indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.

• NeoPharm Inc., of Lake Forest, Ill., said a provider of proxy advisory services, Glass Lewis & Co., recommended to its institutional clients that they support NeoPharm's current board and withhold consent from the nominees of John Kapoor. The company's former chairman, Kapoor has initiated a consent solicitation seeking the removal of NeoPharm's four independent directors and the election of his three nominees in their place, among other things. (See BioWorld Today, Sept. 7, 2004.)

• Nonlinear Dynamics Ltd., of Newcastle upon Tyne, UK, and GenoLogics Life Sciences Software Inc., of Victoria, British Columbia, entered a global partnership to work toward a fully integrated protein informatics solution. The deal brings together Nonlinear's image analysis and data mining expertise with GenoLogics' LIMS technology. Financial terms were not disclosed.

• Norak Biosciences Inc., of Research Triangle Park, N.C., signed a second license agreement to allow AstraZeneca plc, of London, to continue to use Norak's Transfluor Technology in its G protein-coupled receptor drug discovery program. AstraZeneca will use Transfluor to advance lead compounds discovered from a primary high-throughput screen using Transfluor under a June 2002 agreement. Those terms called for Norak to develop a cell line for an AstraZeneca GPCR target of interest that was then screened by AstraZeneca. Financial terms were not disclosed.

• ProBioGen AG, of Berlin, entered a cell line development program with Millennium Pharmaceuticals Inc., of Cambridge, Mass. ProBioGen will use its position-mediated expression-enhancement strategy to develop cell lines for the company's antibodies and for the manufacture of preclinical trial materials.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said a report of an Oxycyte study in a rat stroke model was accepted for publication in the journal Neurological Research. A poster was presented last week at the American Society of Anesthesiologists meeting in Las Vegas highlighting the effects of Oxycyte on cerebral circulation in the rat. The company is preparing to start Phase II trials of Oxycyte.

• Theravance Inc., of South San Francisco, said results from a Phase II study of telavancin (TD-6424) in patients with complicated Gram-positive skin and skin-structure infections were presented at the 42nd annual Infectious Disease Society of America meeting in Boston. Results from the Phase II study found that efficacy was similar to standard therapy, but telavancin demonstrated a higher cure rate (82 percent) compared with standard therapy (69 percent) in the subset group of patients with methicillin-resistant S. auerus at baseline. Results from the in vitro experiments demonstrated telavancin's bactericidal activity against S. aureus is mediated by multiple mechanisms.

• ViroPharma Inc., of Exton, Pa., finalized its license agreement under which Schering-Plough Corp., of Kenilworth, N.J., assumed responsibility for all future development and commercialization of pleconaril. Schering-Plough will pay ViroPharma an initial license fee of $10 million and thereafter will purchase ViroPharma's existing inventory of bulk drug substance for up to an additional $6 million. ViroPharma also is eligible to receive up to an additional $65 million in milestone payments upon achievement of certain targeted regulatory and commercial events, as well as royalties on Schering-Plough's sales of intranasal pleconaril in the licensed territories. The deal was reported more than two months ago. (See BioWorld Today, Aug. 24, 2004.)