• Axaron AG, of Heidelberg, Germany, is beginning Phase II trials of its stroke therapy drug candidate, AX200. The company said the compound prevents the death of nerve cells after stroke, and it promotes regeneration of damaged brain tissue. Axaron began operations in 1997 as a joint venture between BASF AG and Lynx Therapeutics Inc.

• Biomira Inc., of Edmonton, Alberta, said a Phase II trial is under way to test its immunotherapy technology in patients with progressive ovarian cancer. The study is being conducted under the watch of CancerVac, a subsidiary of Prima BioMed Ltd., of Melbourne, Australia. In March, Biomira agreed to license exclusive worldwide rights to the MUC1 protein in relation to CancerVac's Mannan fusion protein therapeutic vaccine being used in the study. The Biomira MUC1 patent portfolio includes certain rights to patents held by Cancer Research Technology Ltd., of London.

• Bionomics Ltd., of Adelaide, Australia, agreed to a collaborative study of its BNO69 gene, which shows promise in treating cancer, with the Louisiana State University Health Sciences Center in Shreveport. Under the agreement, the school's gene delivery technology will be used to deliver gene expression-silencing molecules to solid tumors. The partners said such delivery might result in the disruption of blood vessel formation and tumor growth arrest. Bionomics will have commercialization rights on resulting cancer treatments.

• BioOne Corp., of Tokyo, has entered an agreement with Cerus Corp., of Concord, Calif., and Baxter International Inc., of Deerfield, Ill., through their subsidiaries, to commercialize the Intercept Blood System for platelets in parts of Asia. The system is designed to reduce the risk of transfusion-transmitted diseases by inactivating certain pathogens that might be in donated platelets. The technology is approved for use in Europe. BioOne will market and distribute the system in Japan, China, Taiwan, South Korea, Thailand, Vietnam and Singapore, after receipt of regulatory approval in those countries. The agreement is subject to approval by BioOne shareholders, following completion of an independent appraisal of the transaction in accordance with Japanese law.

• BioSight Ltd., of Karmiel, Israel, said that Coastal Holdings Inc., of Houston, signed a draft investment agreement to purchase an equity interest in the company. Terms were not disclosed. BioSight uses its S2DOT (Seek to Destroy Only Target) technology for the identification of disease-specific markers. The company develops pro-drug vectors for selective drug targeting.

• Cenix BioScience GmbH, of Dresden, Germany, and Ambion Inc., of Austin, Texas, launched an RNA interference library targeting the Drosophila genome. It consists of more than 13,000 double-stranded RNA molecules for experimental use without further synthesis or purification steps.

• Chemoprojekt a.s., of Prague, Czech Republic, bought the raw materials and manufacturing operations of Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., in the Czech Republic. The operations previously were reported as discontinued operations by Valeant. Terms were not disclosed.

• Evotec OAI AG, of Hamburg, Germany, and ActivBiotics Inc., of Lexington, Mass., entered a drug discovery project. Evotec OAI will apply its rational drug design platform, EVOrationale, to one of ActivBiotics' anti-infective lead optimization programs. Financial terms were not disclosed.

• Flamel Technologies SA, of Lyon, France, started construction of a new pilot plant and manufacturing facility adjacent to its existing research, development and production center at Pessac, in western France. The new facility is expected to cost $10 million and should be completed before year end. About half the cost will be covered by the company's partners and French government funding. Flamel CEO Gérard Soula said the plant would enable the company to scale up polymer production for its Medusa drug delivery system, as well as give it the capacity to expand its output of biopharmaceutical products incorporating its other delivery system, Micropump. Also, Flamel announced a net profit of $2.7 million for the first half of 2004, compared to a loss of $3.3 million in the first six months of 2003, reflecting a jump in total revenues from $8.5 million to $23.3 million from one period to the next.

• Gamida-Cell Ltd., of Jerusalem, completed enrollment in its Phase I/II trial of StemEx for leukemia. The company expects initial results within the next six months. It also said preclinical data published in this month's issue of Cytotherapy describe the research underlying StemEx, a unit of an expanded population of stem cells derived from cord blood.

• Genome Express, of Grenoble, France, and Paris-based Institut Pasteur signed an agreement giving Pasteur access to Genome Express's functional genomics platform, especially in the field of bacterial genomics. The agreement also provides for future co-development of biopharmaceutical and agrifood products and services. Financial terms were not disclosed.

• Ingenium Pharmaceuticals AG, of Munich, Germany, achieved a milestone in its Ingenotyping agreement under which it develops specific genetic mouse models for Bayer HealthCare AG, a subgroup of Bayer AG, of Leverkusen, Germany. Specifically, Ingenium developed mouse models for Bayer target genes, though the companies did not disclose financial terms or further details of the ongoing agreement.

• Innate Pharma SAS, of Marseille, France, raised €15 million in a third round of financing. The company said the funds would be used to continue its clinical development programs and begin developing newly identified molecules. Innate, which approaches drug development based on the pharmacology of non-conventional lymphocyte populations such as natural-killer and gamma-delta T cells, has raised more than €40 million since its creation in 1999. The latest financing included new investors Novo Nordisk A/S, Quilvest and NIF Ventures, as well as existing investors Sofinnova Partners, Alta Partners, GIMV, Auriga Partners, Axa Private Equity, Gilde Biotech & Nutrition and Innoveris.

• Lectus Therapeutics Ltd., of Bristol, UK, announced a collaboration with Evotec OAI, of Hamburg, Germany, in which Evotec will provide medicinal chemistry services for Lectus' ion channel drug discovery and development program. Lectus is focusing on second-generation ion channel modulators for the treatment of disorders related to smooth muscle hyper reactivity, including urinary bladder disorders, angina and hypertension. The company has a technology platform, Leptics, for identifying small molecules that modulate the interaction between ion channel accessory proteins and the pore-forming domain counterparts in ion channels.

• Lonza Group Ltd., of Basel, Switzerland, and Codexis Inc., of Redwood City, Calif., entered an agreement to commercialize a new process for the synthesis of an undisclosed chiral pharmaceutical compound. Codexis has developed a biocatalytic process using its MolecularBreeding-directed molecular evolution platform, which Lonza will use for the commercial manufacture and supply of the compound. The process employs enzyme catalysts and uses raw materials produced in bulk by Lonza. Each enzyme has been evolved by Codexis, which will receive license fees and royalties from Lonza, and will sell commercial quantities of the biocatalysts to Lonza for use in the production process.

• MWG Biotech AG, of Ebersberg, Germany, said it signed a global supply contract for oligonucleotides with an unnamed international pharmaceutical firm. MWG added that it expects an annual turnover of about €1 million to result from the synthetic nucleic acid supply agreement. Further details were not disclosed.

• NV Organon, of Oss, the Netherlands, has agreed to use Gaithersburg, Md.-based Gene Logic Inc.'s platform of toxicogenomics services to assist in the assessment and prioritization of a preclinical pipeline. Over the next 18 months, Gene Logic will provide a series of ToxScreen reports and Mechanism of Toxicity reports for use in evaluating the safety and toxicity of Organon's drug candidates. Financial terms were not disclosed.

• Peplin Biotech Ltd., of Brisbane, Australia, said its lead molecule, PEP005, has shown selective activity against acute myelogenous leukemia in preclinical studies. Based on that and other preclinical data, the company plans to file an investigational new drug application with the FDA to begin clinical trials of an intravenous formulation of the compound for leukemia.

• Proteome Sciences plc, of Cobham, UK, fell from £1.09 to 62.25 pence on July 30 after partner Biosite Inc., of San Diego, announced it would not be including Proteome's stroke biomarkers in its first-generation, point-of-care stroke diagnostic machine. Proteome said the delay was due to "the need to further evaluate recent data," and Biosite would continue to evaluate the Proteome stroke makers for use in the future. Biosite said it has selected six disease markers for its stroke diagnostic panel after analyzing more than 50 potential markers from more than 1,600 patient samples. It plans to file a pre-marketing approval with the FDA later this year.

• Qiagen NV, of Venlo, the Netherlands, entered a global supply agreement with Novartis Pharma AG, of Basel, Switzerland. Qiagen will be its global supplier for consumable products for nucleic acid stabilization, separation, purification, handling and amplification, as well as automated instrumentation, siRNA products and related services. Financial terms were not disclosed.

• ScheBo Biotech AG, of Giessen, Germany, said findings published in the British Journal of Cancer detail the use of a test that detects cancer cells in the stool through the enzyme Tumor M2-PK. Researchers from the University Clinic of Giessen investigated the marker in their study of a patient group with colorectal cancer and a healthy control group of 204 subjects altogether, all of whom underwent colonoscopy. The sensitivity of the new test was between 60 percent and 90 percent, according to the tumor stage, while, the company said, current tests such as blood in the stool tests have a sensitivity of about 25 percent.

• Sigma-Tau SpA, of Rome, is in an oral understanding with BioDelivery Sciences International Inc., of Newark, N.J., to out-license BioDelivery's formulation and delivery technology in connection with different compounds, particularly in oncology. Under the proposed licensing agreement, which is subject to further negotiation and execution, Sigma-Tau would pay an initial $250,000 up-front payment upon signing a letter of intent and an additional $750,000 upon the accomplishment of certain milestones leading to the filing of the first investigational new drug application for a compound formulated with the technology. Should a definitive license agreement be executed, BioDelivery said it would receive additional milestone payments and royalties on sales.

• Syngenta AG, of Basel, Switzerland, is in an expanded agreement with Diversa Corp., of San Diego, in the area of animal feed enzymes on an exclusive basis in exchange for an exclusivity fee and continued research and development funding. Zymetrics, an existing contract joint venture for animal feed enzymes, will be managed exclusively by Syngenta. At the same time, Syngenta and Diversa will collaborate on other enzymes and selected antibody and other biopharma products. The agreement also provides for a number of Syngenta employees to be relocated to work with Diversa in San Diego, and Diversa will assist Syngenta in developing the strategic direction of Syngenta's investment in enzymes.

The German Ministry of Research and Education (BMBF) reported on the effects of the first 18 months - July 2002 through December 2003 - of Germany's law regulating research with stem cells. The law permits only stem cells harvested before Jan. 1, 2002, to be used for "important research goals." In 2001-2006, BMBF support for projects using embryonal stem cells will total three projects, with financial support of €900,000. Overall, the BMBF will support 37 projects, with €7.3 million in funding, that use some form of stem cell: animal, embryonal or adult.

• TranXenoGen Inc., of Shrewsbury, Mass., which is listed on the Alternative Investment Market in London, is axing its research activities, becoming the latest company to fail in the field of producing human proteins in transgenic animals. The company is selling its Shrewsbury facility and cutting its work force from 14 to three. Remaining staff will concentrate on out-licensing the avian transgenic technology. TranXenoGen was founded by Kim Tan, who also founded the polyclonal antibody company KS Biomedix plc.

• Vernalis plc, of Reading, UK, said positive results from the preliminary Phase III trial of Frova in the treatment of menstrually associated migraine (MAM), were published in Neurology. The study, carried out at the Thomas Jefferson University in Philadelphia, showed Frova reduced the incidence of MAM, for which there is currently no approved treatment. Last month Vernalis agreed to a North American marketing agreement for Frova with Endo Pharmaceutical Holdings Inc., of Chadds Ford, Pa. with a potential value of $400 million. That includes a milestone payment of $40 million due on FDA approval of the use of Frova to treat MAM.

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