• Access Pharmaceuticals Inc., of Dallas, entered a licensing agreement with the Zambon Group, of Milan, Italy, granting exclusive marketing rights in France, Germany, Holland, Belgium, Luxembourg, Switzerland, Brazil and Columbia and a semi-exclusive license for Italy for amlexanox to treat canker sores. Zambon will pay an up-front licensing fee, make milestone payments and purchase the finished product from Access. Access said all its amlexanon deals could generate about $6.7 million in licensing fees, milestone payments and research support payments, with $1.5 million already paid. The Zambon agreement also includes a provision to further extend the territory. The rights are for amlexanox 5 percent paste, marketed in the U.S. and approved in the UK, and OraDisc, a product candidate in Phase III testing. Zambon also has the rights to any future product improvements for amlexanox to treat canker sores.

• Amedis Pharmaceuticals Ltd., of Cambridge, UK, entered a collaboration agreement with Argenta Discovery Ltd., of Harlow, UK, to focus on the application of Amedis' artificial intelligence technology platform to further enhance Argenta's drug discovery processes. Amedis has developed technologies in both in silico prediction of drug properties and in the chemical modification of drugs to provide better drug-like properties. Financial terms were not disclosed.

• Atrix Laboratories Inc., of Fort Collins, Colo., submitted to the FDA three abbreviated new drug applications for generic formulations of undisclosed dermatology products. Atrix said no generic equivalents of the products are marketed, adding that the company has seven such applications on file with the agency.

• BioMS Medical Corp., of Toronto, received proceeds of about C$2.6 million (US$1.7 million) from the exercise of about 658,700 share purchase warrants. The warrants entitled the holders to acquire one common share at a price of C$4 per share on or before Dec. 31. It said it would use the funds to further develop its technologies in the treatment of multiple sclerosis.

• Biovitrum AB, of Stockholm, Sweden, entered a commission agreement with Lundbeck A/S, of Copenhagen, Denmark, for the production of a protein therapeutic. Lundbeck, which specializes in central nervous system disorders, has acquired the rights to a new protein therapeutic from Maxygen Inc., of Redwood City, Calif. Biovitrum will assist Lundbeck in process implementation and manufacturing of material for further investigations. Financial terms of the two-and-a-half-year agreement were not disclosed.

• Corixa Corp., of Seattle, and the Infectious Disease Research Institute in Seattle initiated a Phase I trial to test the safety and tolerability of a vaccine to treat or protect against various forms of human leishmaniasis. Identified as Leish-111f, the vaccine consists of a fusion of three Leishmania proteins in combination with Corixa's monophosphoryl lipid A (MPL-SE) adjuvant, a derivative of the lipopolysaccharide of Salmonella minnesota. The double-blind, randomized trial is designed to evaluate the safety of Leish-111f plus adjuvant administered subcutaneously to healthy adult volunteers at three dosing levels.

• DOR BioPharma Inc., of Lake Forest, Ill., executed a letter of intent to exclusively license international patent applications covering intranasal microencapsulated vaccine technology, including anthrax and plague, invented and tested by the UK's Ministry of Defence. The only FDA-approved anthrax vaccine, BioThrax, requires six injections given over 18 months, with annual booster injections recommended thereafter, the company said. Research at the ministry showed that an experimental microencapsulated, intranasally delivered anthrax vaccine was capable of protecting 100 percent of animals against lethal challenge to anthrax spores with only two intranasal administrations.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., signed a license and development agreement with Photnamic GmbH & Co. KG, a recently formed subsidiary of pharmaceutical company Medac GmbH, of Hamburg, Germany, and a supply agreement with Medac. The agreements provide for the licensing to DUSA of Photonamic's technology related to aminolevulinic acid, the compound used in DUSA's Levulan Photodynamic Therapy and Photodetection for particular indications.

• Evotec OAI AG, of Hamburg, Germany, signed a drug discovery agreement with KeyNeurotek AG and the Institute of Medical Technology Magdeburg GmbH, both in Magdeburg, Germany, to identify small-molecule drug candidates to treat distinct central nervous system, autoimmune, allergic and dermatologic diseases. Evotec will assist KeyNeurotek and IMTM in developing new lead structures to two targets.

• Galenica Pharmaceuticals Inc., of Birmingham, Ala., entered into a collaborative agreement with the National Center of Biotechnology (CNB) in Madrid, Spain, to develop a safe genetically engineered subunit vaccine against smallpox. The CNB will provide the viral antigens responsible for protective immunity against vaccinia virus to be formulated with Galenica's immune enhancer or adjuvant GPI-0100.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, said it is providing its investigational immune-regulating hormone drug candidates to the Walter Reed Army Institute of Research in Forest Glen, Md., to be tested for activity in preclinical models against a variety of bioterrorism agents, as well as parasitic, bacterial and viral infections of military interest. The compounds are expected to be evaluated by the military either alone or in combination with currently used drugs. In addition, the compounds may be assessed for their effectiveness in enhancing vaccines being developed by the research institute.

• Iconix Pharmaceuticals Inc., of San Leandro, Calif., entered an agreement to link its DrugMatrix with the ISIS Enterprise Edition of MDL Information Systems Inc., of Mountain View, Calif. The pairing is designed to provide subscribers access to the genomic, chemical, toxicology and pharmacology information in Iconix's database by using all the ISIS structure-searching tools.

• Introgen Therapeutics Inc., of Houston, reported publication in the January 2003 issue of Clinical Cancer Research of its Phase II study combining Advexin, an adenoviral vector containing the p53 tumor-suppressor gene, with radiation therapy. The study, treating patients with non-small-cell lung cancer, showed that about 60 percent of patients' primary tumors regressed or disappeared after the combination therapy, as assessed by biopsies and CT scans three months after treatment. Also, Introgen said Advexin administration did not appear to increase the side effects caused by radiation. Introgen's stock (NASDAQ:INGN) gained 80 cents Tuesday, or 35.6 percent, to close at $3.05.

• Kosan Biosciences Inc., of Hayward, Calif., said its collaboration with Johnson & Johnson Pharmaceutical Research and Development LLC, of La Jolla, Calif., and Ortho-McNeil Pharmaceutical Inc., of New Brunswick, N.J. - both Johnson & Johnson companies - was extended until Dec. 28. Kosan is producing macrolide antibiotic leads and J&J is responsible for characterization and development of the compounds. Marketing and sale of any resulting drugs would be undertaken by Ortho-McNeil.

• Luminex Corp., of Austin, Texas, and Tm Bioscience Corp., of Toronto, released the Universal Array, a microsphere-based product designed for conducting genotyping and other DNA-based experiments in the life sciences and diagnostic markets using Luminex's xMAP technology. The Universal Array microspheres, used in conjunction with Luminex's multiplexing technology, are designed to simplify the genotyping assay development process and increase assay flexibility.

• MDS Proteomics Inc., of Toronto, a subsidiary of MDS Inc., and Eli Lilly Canada Inc., of Toronto, signed an initial pilot study agreement to explore the use of MDSP's technology called PhosMap. The study will focus on Lilly's drug candidates and is designed to assess the capability of the technology to determine the effects of kinase inhibitors on kinase targets that may span several therapeutic areas.

• Medicure Inc., of Winnipeg, Manitoba, said both primary and secondary endpoints were met in a Phase II study of its lead compound, MC-1. The primary endpoint of the randomized, placebo-controlled, blinded trial was infarct size during the procedure as determined by the release of the amount of the CK-MB marker cardiac enzyme more than 24 hours following percutaneous coronary intervention. Improvement in secondary endpoints included myocardial ischemia measured by continuous ST-segment electrocardiographic monitoring, peak periprocedural CK- MB through 24 hours and clinical tolerability and safety. Medicure's stock (TSE:MPH) gained C11 cents Tuesday, or 18.6 percent, to close at C70 cents.

• PBL Therapeutics, a wholly owned subsidiary of PBL Biomedical Laboratories, of Piscataway, N.J., was awarded $1.38 million from the National Cancer Institute in Bethesda, Md., to enable the company to continue commercialization of one of its technology platforms. The company will collaborate with the Robert Wood Johnson Medical School and the New Jersey Medical School of the University of Medicine & Dentistry of New Jersey. PBL Therapeutics is producing a next generation of interferon molecules, called ultra interferons, which can be 25 to 30 times more potent than those currently used in therapy, the company said.

• Proligo USA, of Boulder, Colo., said it is expanding its production capacity for oligonucleotide synthesis for the research market in both the U.S. and Japan to meet growing demand in both those regions. In the U.S., Proligo has built such a facility at its headquarters in Boulder, which is already supplying oligonucleotides to the U.S. market, the company said. In Japan, Proligo has doubled its capacity at its production site in Kyoto.

• Variagenics Inc., of Cambridge, Mass., granted a worldwide license relating to its MTHFR (methylenetetrahydrofolate reductase) patent rights to Celera Diagnostics, a joint venture between the Applied Biosystems Group, of Foster City, Calif., and the Celera Genomics Group, of Rockville, Md. Variagenics granted Celera Diagnostics worldwide nonexclusive rights to commercialize products for the detection of MTHFR polymorphisms for applications including assessment of thromboembolic disease risk, including stroke and myocardial infarction. The products are expected to be sold as analyte-specific reagents and potentially later as in vitro diagnostic devices. Variagenics retains the rights to develop pharmacogenomic applications in oncology and other disease areas. Additional terms were not disclosed.