• Alchemia Ltd., of Brisbane, Australia, was notified of its successful application for a grant worth up to A$7.8 million (US$6.3 million) under the government's Pharmaceutical Partnerships Program. The grant entitles Alchemia to funding over three years starting July 1 to support a number of its drug development projects, dependent on it meeting forecast R&D expenditure for the period.

• ChemDiv Inc., of San Diego, extended and expanded its collaboration with Seattle-based Dendreon Corp. to supply Dendreon with medicinal and custom chemistry services for discovery programs in targeted cancer therapies. Financial terms were not disclosed.

• CytoGenix Inc., of Houston, announced preclinical development of CY403, an antibacterial compound that is specific against all strains of Staphylococcus aureus, especially resistant strains such as MRSA (methicillin-resistant) and VRSA (vancomycin-resistant). The company reported that laboratory studies showed the compound is a bactericidal and bacteriastatic agent against MRSA, and is planning additional animal and human trials to confirm those results.

• Generex Biotechnology Corp., of Toronto, filed a provisional patent application with the U.S. Patent and Trademark Office for its oral/buccal metformin formulation. The company developed a platform technology for the delivery of pharmaceuticals into the human body through the oral cavity with no deposit in the lungs. Its liquid formulations allow pharmaceuticals typically administered by injection or ingestion to be absorbed through the lining of the inner mouth.

• GenWay Biotech Inc., of San Diego, entered an exclusive licensing agreement with Fullerton, Calif.-based Beckman Coulter Inc. GenWay will provide Beckman Coulter will access to its IgY microbead technology, which can be used for enhancing the detection of biomarkers and drug targets in biomedical research. The agreement also provides a basis for future collaboration on the development of GenWay's IgY capture technology. Financial terms were not disclosed.

• Halozyme Therapeutics Inc., of San Diego, and Baxter Healthcare Corp., of Deerfield, Ill., expanded their relationship by signing a development and supply agreement for Enhanze SC, a recombinant human hyaluronidase enzyme. The companies signed an exclusive sales and marketing agreement in August. With the expanded agreement, Baxter will fill and finish Enhanze SC and market, distribute and sell it in the U.S. and Puerto Rico. Last week, Halozyme filed a new drug application for the product to be used as a spreading agent to enhance the delivery of local anesthesia, contrast agents and for subcutaneous fluid replacement. (See BioWorld Today, March 29, 2005.)

• Hemosol Corp., of Toronto, implemented the Cascade technology for the extraction of therapeutic plasma proteins at a 30-liter scale, and also announced financings to raise C$13.4 million (US$11.1 million) The company said the technology has met or exceeded yield expectation and demonstrated significant improvement over existing manufacturing methods. Achievement of those milestones will allow Hemosol to move to clinical-scale production later in the year. In addition to agreements for raising the C$13.4 million, the company also announced an extension of Toronto-based MDS Inc.'s guarantee of Hemosol's C$20 million credit facility and the amendment of the Cascade license agreement in which ProMetic Biosciences Inc., a subsidiary of Montreal-based ProMetic Life Sciences Inc., will accept a combination of cash and common shares of Hemosol as part of the licensing fee. Hemosol is focused on the development and manufacturing of blood-related proteins.

• ICOS Corp., of Bothell, Wash., and Montreal-based Caprion Pharmaceuticals Inc. entered an agreement for the development of therapeutic antibodies to treat cancer. Caprion will contribute a selection of antibody targets and perform certain characterization activities, while ICOS will be responsible for target validation and preclinical development. Terms include an up-front payment and license fee to Caprion, as well as potential reciprocal milestone payments and royalty payments. The companies may choose to co-develop and co-promote certain products.

• ImmunoGen Inc., of Cambridge, Mass., submitted an investigational new drug application to the FDA for its huC242-DM4 targeted cancer therapeutic. The Tumor-Activated Prodrug compound is in development to treat CanAg-expressing cancers, such as gastrointestinal and non-small-cell lung cancers. The company intends to begin patient dosing in the middle of the year.

• Lexicon Genetics Inc., of The Woodlands, Texas, reached an agreement with Deltagen Inc., of Redwood City, Calif., concerning its claim in Deltagen's bankruptcy proceedings and the assumption by Deltagen of a sublicense agreement from Lexicon. The sublicense grants Deltagen nonexclusive rights to gene-targeting technologies for the generation of knockout mice. Lexicon received an initial payment of $4 million in connection with the settlement, and it could receive up to $6 million from Deltagen's net licensing revenues from existing lines of knockout mice and related phenotypic data. Lexicon also is entitled to receive royalties on Deltagen's net licensing revenues from any lines of knockout mice generated in the future.

• Ligand Pharmaceuticals Inc., of San Diego, presented initial results from two studies of Avinza in chronic back pain and moderate to severe osteoarthritis at the American Pain Society's annual meeting in Boston. In the first study, Avinza showed better control of chronic pain and improved sleep when given once daily, compared to oxycodone given twice daily. The second study demonstrated Avinza's ability to provide better sleep, as well as improved pain control for osteoarthritis patients. Additional results will be provided later this year. Avinza, an oral morphine sulfate extended-release capsule, is a once-a-day treatment for patients taking continuous opioid therapy for an extended period of time. In other news, Ligand announced that it has received as Nasdaq staff determination letter regarding potential delisting of the company's stock, due to Ligand's inability to file its annual report.

• Memory Pharmaceuticals Corp., of Montvale, N.J., is adding a fifth development candidate to its pipeline, MEM 63908, to treat Alzheimer's disease. The compound is a partial agonist of the nicotinic alpha-7 receptor and belongs to a family of nicotinic alpha-7 receptor agonists that the company is developing in its collaboration with Basel, Switzerland-based F. Hoffmann-La Roche Ltd. In preclinical testing, MEM 63908 has demonstrated improved learning and memory function in healthy and cognitively aged-impaired animals and has demonstrated a good safety profile.

• Metabasis Therapeutics Inc., of San Diego, said a Phase I trial of CS-917 is continuing and it might start one or more additional Phase I trials to evaluate the drug. The company is working with its partner, Sankyo Co. Ltd., of Tokyo, and other experts to evaluate the implications of serious adverse events and to find a path forward for the drug. Sankyo halted two studies with CS-917, the glucose pathway inhibitor for diabetes, last week after two events of potentially fatal lactic acidosis. (See BioWorld Today, March 17, 2005.)

• Osiris Therapeutics Inc., of Baltimore, has begun a multicenter, randomized trial of Provacel, a therapeutic based on adult mesenchymal stem cells. Provacel is a formulation of MSCs shown to repair damaged tissue that can be administered intravenously with the delivered cells designed to respond to the body's own signals and migrate to the area of the injury. Osiris recently received FDA fast-track designation for a similar stem cell product, Prochymal, for the treatment of graft-vs.-host disease in cancer patients.

• PTC Therapeutics Inc., of South Plainfield, N.J., said its cystic fibrosis drug, PTC124, has been granted fast-track designation by the FDA, which will facilitate the development and expedite the regulatory review. In December, the company received orphan drug designation for PTC124, an orally delivered investigational drug in development for the treatment of genetic disorders due to nonsense mutations, single-point alterations in the genetic code that prematurely halt the translation process, causing a shortened, non-functional protein.

• Rigel Pharmaceuticals Inc., of South San Francisco, completed its Phase I study of R406 to treat rheumatoid arthritis. Based on preliminary results, R406 was well tolerated at the dose levels that Rigel plans to use moving forward. The study also generated data establishing a correlation between R406 plasma levels and the inhibition of its target. Rigel intends to initiate a Phase I/II safety trial in the second half of this year.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Chemicon International Inc., and OctoMethylome Sciences SA, of Leige, Belgium, entered an agreement in which OMS licensed Chemicon's patented fluorescent detection technology, Amplifluor, for the development of diagnostic assays detecting DNA methylation patterns. The Amplifluor system can be used for a variety of nucleic acid-amplification techniques, and can be incorporated in drug discovery, with other applications in genomics, clinical diagnostics, forensics, biothreat and food testing. Financial terms were not disclosed.

• Sinovac Biotech Ltd., of Beijing, launched Bilive, its combined hepatitis A and B vaccine during a meeting held March 25-27 in Huang Mountain, Anhui Province, China. The company expects to record the first sales of Bilive by May. Sinovac received final approval from the Chinese drug regulatory body in January for the marketing and sales of Bilive, a combined vaccine formulated by purified hepatitis A virus antigen and recombinant (yeast) hepatitis B surface that is absorbed into aluminum hydroxide.

• StemCells Inc., of Palo Alto, Calif., said progress has been made with the FDA toward the company's goal of initiating Phase I testing of its neural cell therapy product, HuCNS-SC, in Batten disease. The FDA put the trial on hold in February. StemCells is preparing an amendment to its original investigational new drug application filing and will resubmit it to the FDA. The proposed study would mark the first-ever FDA-approved trial to use a purified composition of human neural stem cells.

• U.S. BioDefense Inc., of City of Industry, Calif., filed a proposal in response to an RFA with the National Institutes of Health in Bethesda, Md., for the establishment of a Center of Excellence in Translational Human Stem Cell Research. The specific aim of the center is to research the development of a product and system that will isolate and expand stem cells, which might be used for therapeutic liver repopulation in patients with healthy cells for patients with liver disease, especially, but not exclusively, acute liver failure.

• Valentis Inc., of Burlingame, Calif., initiated patient dosing on schedule in a Phase IIb trial of VLTS-934, a non-ionic, block copolymer known as poloxamer. Valentis said it appears to produce a therapeutic benefit in ischemic tissue. About 148 patients with peripheral arterial disease will receive either VLTS-934 or a saline placebo in the randomized, double-blinded trial.

• VaxGen Inc., of Brisbane, Calif., entered a purchase agreement with a group of investors for the private placement of $31.5 million of its 5.5 percent convertible senior subordinated notes due 2010. The placement, which is no longer open to new investors, is set to close April 5. The notes will require semi-annual payments of interest in cash at a rate of 5.5, will convert into VaxGen common stock at an initial conversion price of about $14.76 per share or convert into common stock if the company's common stock reaches a price of $22.14 per share, and will constitute senior subordinated obligations of VaxGen. The company is working on vaccines against anthrax and smallpox.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said its collaboration with Pfizer Inc., of New York, was extended for another year. The collaboration, which originated with Pharmacia in March 1999, was established to develop next-generation oxazolidinones, the first new class of antibiotics in more than 30 years, the company said. Financial terms were not disclosed.