• Active Biotech, of Lund, Sweden, initiated a Phase I dose-escalation study of TASQ for prostate cancer. The four-week tolerance study could be extended up to one year to assess long-term tolerability and safety. The study includes patients who did not respond well to hormonal therapy. Patient recruitment will continue into 2005 at urology clinics in Sweden.

• Altana AG, of Bad Homburg, Germany, said the 90-day phase of the European mutual recognition procedure is complete, and the company may market Alvesco (ciclesonide) in various European markets in 2005 to treat persistent asthma. Altana received approval for Alvesco in the UK in April. The company soon expects to receive national marketing licenses for Germany, the Benelux countries, Scandinavia and Eastern Europe.

• Aureus Pharma, of Paris, entered an agreement to establish Infocom Corp., of Tokyo, as the exclusive distributor of Aureus' products in Japan. Infocom will distribute Aureus' AurScope databases, AurScope GPCR, ADME/Drug-Drug Interactions and Ion Channel, as well as AurQuest, web-based software for interrogating the databases. Financial terms were not disclosed.

• Bionest Partners, of Paris, created a new business unit dedicated to providing support and advisory services to biotechnology start-ups. Called Bionest Start-Up, it is based at the Biocitech life sciences technology and business park in the Paris suburb of Romainville, which was created in 2003 on the site of a former research and development center of the Sanofi-Aventis Group. Bionest Partners has played a part in creating three biotechnology firms there.

• Biosignal Ltd., of Sydney, Australia, was advised that early stage laboratory research led by Diane McDougald, a senior research associate in the Centre for Marine Biofouling and Bio-Innovation at the University of New South Wales, demonstrates the efficacy of Biosignal's furanones against bacteria that cause cholera. Among the conclusions of the research, the lab tests demonstrated that when the bacteria that cause cholera, Vibrio cholerae, are exposed to furanones, they cannot switch on the so-called virulence factors that trigger infection and disease development.

• BioVisioN AG, of Hannover, Germany, entered a service agreement to use its Differential Peptide Display technology to evaluate clinical samples provided by Novartis Pharma AG, of Basel, Switzerland, to find and identify clinically relevant peptides. Financial terms were not disclosed.

• BrainStorm Cell Therapeutics Ltd., of Tel Aviv, Israel, leased space in Kiryat Ha'Mada Ve Ha'Technologia in Petach Tikva. The space will be used as an R&D facility, and for corporate offices. Brainstorm is focused on developing NurOwn cell-therapy products derived from adult stem cells that might treat neurodegenerative diseases.

• Capio AB, of Gothenburg, Sweden, acquired Laboratorium for Klinisk Mikrobiologi, of Oslo, Norway, a diagnostic testing firm with 17 employees and annual revenues of NOK13 million (US$2.1 million). The acquisition will become part of Capio's diagnostics business unit, which has annualized revenues of SEK1.2 billion (US$177 million).

• Cell Therapeutics Inc., of Seattle, said that Nippon Shinyaku Co. Ltd., of Kyoto, Japan, launched Trisenox in Japan after receiving pricing approval from the Japanese Ministry of Health for patients with relapsed or refractory acute promyelocytic leukemia. CTI markets Trisenox in the U.S. and Europe. CTI also reported that it signed agreements with five new distributors of Trisenox in Latin America, Eastern Europe, Israel, Turkey and South Africa.

• Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, signed a memorandum of understanding with the University of Queensland's Institute for Molecular Biosciences to collaborate on the identification of potential therapeutics for cardiovascular diseases. The IMB will provide Cryptome with compound libraries, which Cryptome will screen for activity using its Cryptomics platform technology. That platform is based on finding small protein fragments with previously undiscovered therapeutic activities.

• Cytos Biotechnology AG, of Zurich, Switzerland, initiated a combined Phase I/II trial with the Immunodrug candidate CYT006-AngQb, a therapeutic vaccine for hypertension. The study will include 16 normotensive and 72 hypertensive participants with mild to moderate hypertension. Efficacy will be determined by measuring systolic and diastolic blood pressure. First results are expected in the second half of 2006.

• Definiens AG, of Munich, Germany, and BioImage A/S, of Copenhagen, Denmark, began a partnership to devise new applications for the high-content screening market. Definiens specializes in software tools for automated analysis of graphic data, while BioImage concentrates on drug discovery and assay services. The companies expect to offer detailed data extraction from cellular assays, and promise improved flexibility and throughput. Financial details were not disclosed.

• Domantis Ltd., of Cambridge, UK, launched AlbudAb, a domain antibody technology for improving the efficacy of small-molecule and peptide and protein therapeutics by increasing their half-life. AlbudAbs bind to serum albumin in the blood, extending the half-life of drugs that are conjugated to them. Domantis has demonstrated the technology in three studies with proteins that normally would clear rapidly from the body.

• Evolutec Group plc, of Oxford, UK, announced preclinical results showing its lead product, rEV131, is effective in treating inflammation of the eye. The company intends to carry out a U.S. Phase II trial in post-cataract surgery in 2005. REV131, a histamine-binding protein, is in Phase II in allergic rhinitis and conjunctivitis.

• Flamel Technologies SA, of Lyon, France, enrolled the first patient in a Phase I/II study of Flamel's Medusa formulation of long-acting interleukin-2 in comparison with Proleukin. Proleukin is the only treatment approved for renal cancer. Flamel's formulation resulted in measurable increases in levels of lymphocyte CD4 and CD8, as well as CD25, which are considered surrogate markers for stimulation of the body's immune system.

• Genmab A/S, of Copenhagen, Denmark, said the FDA accepted its investigational new drug application to start a Phase I/II dose-escalation trial in the early part of 2005 for HuMax-CD20 to treat active rheumatoid arthritis in patients who have failed one treatment with one or more anti-rheumatic drugs. A total of 60 patients will be randomized into three cohorts. In each cohort, 16 of 20 patients will receive two infusions of HuMax-CD20 and four patients will receive placebo. All patients in the study will receive methotrexate. They will be followed for 24 weeks to evaluate safety and efficacy and then every 12 weeks until B-cell counts return to baseline levels.

• GPC Biotech AG, of Martinsried, Germany, received Swiss regulatory approval to begin Phase I testing of a cancer product, 1D09C3. The study is designed to determine the safety and tolerance of escalating doses of the monoclonal antibody in patients with relapsed or refractory B-cell lymphomas, and to recommend a dose and schedule for Phase II. The product was generated using HuCAL technology from MorphoSys AG, of Munich, Germany. The commencement of clinical trials triggers a milestone payment from GPC to MorphoSys, due on the product's first administration. Specific financial details were not disclosed.

• Guerbet SA, of Roissy, France, and ImaRx Therapeutics Inc., of Tucson, Ariz., entered an agreement to jointly develop a targeted magnetic resonance contrast agent for use in MRIs. The contrast agent would be designed to detect, diagnose and monitor cancers at the molecular level. Formulations will be developed using ImaRx's nanodroplet technology in combination with Guerbet's targeting ligands and magnetic resonance contrast agents. Financial terms were not disclosed.

• Henderson Morley plc, of Birmingham, UK, was granted a U.S. patent on its Ionic Contra Viral Therapy. The technology is in Phase I for the treatment of adenovirus keratoconjunctivitis.

• Inpharmatica Ltd., of London, formed a discovery collaboration with Novartis Institutes for BioMedical Research, a unit of Basel, Switzerland-based Novartis AG. For an undisclosed sum, Novartis Discovery Technologies will use Inpharmatica's Chematica technology to identify molecular targets for Novartis' bioactive compound project. Chematica is capable of target selection through druggability assessment and identification of hits and leads against those targets.

• Intercell AG, of Vienna, Austria, signed an exclusive agreement with SciGen Ltd., of Singapore, to develop a new therapeutic vaccine against hepatitis B virus. The proposed vaccine will combine an HBV antigen from SciGen with an adjuvant from Intercell to induce an immune response. Intercell and SciGen said the companies will share development costs and have joint ownership of products, but did not specify financial details of the partnership.

• Invitrogen Corp., of Carlsbad, Calif., signed an agreement to acquire Shanghai, China-based Bio Asia in an all-cash transaction that will total up to $8 million. Founded in 1999, Bio Asia is a manufacturer and provider of sequencing reagents and supplies and custom research and development services. It has annual revenues of about $5 million. The transaction received approval from both boards and is pending government approval. New World Trade Organization guidelines recently opened the Chinese biotech industry to foreign-owned companies.

• Jerini AG, of Berlin, was awarded €847,000 (US$1.1 million) in funding from the German Federal Ministry for Education and Research to intensify its discovery and preclinical development activities for an orally available bradykinin B2 receptor antagonist. The project could increase the number of indications treatable with Jerini's products. The funding will be paid over a two-year period. Jerini's products include Icatibant, a peptidomimetic bradykinin B2 receptor antagonist, which is in Phase II studies for hereditary angioedema.

• KetoCytonyx Inc., of London, completed a Phase I study of KTX 0101, its lead therapeutic targeting prevention of cognitive impairment in patients undergoing coronary artery bypass graft (CABG) surgery. The product was found to be well tolerated by all 20 volunteers, with no serious adverse events reported, and drug pharmacokinetics were as predicted in the dose-escalation study. Also, statistically significant changes compared to placebo were seen in electroencephalogram recordings, indicating that KTX 0101 had a pharmacodynamic effect on the central nervous system. The effect is similar to that seen in patients when hypothermia was used to provide neuroprotection for patients undergoing CABG surgery and following head injury.

• Laboratorios del Dr. Esteve SA, of Barcelona, Spain, and Discovery Laboratories Inc., of Warrington, Pa., restructured their deal. Discovery regained full commercialization rights in certain European markets, Central America and South America for its Surfactant replacement therapies, including Surfaxin for respiratory distress syndrome in premature infants and acute respiratory distress syndrome in adults.

• LG Life Sciences Ltd., of Seoul, South Korea, and Anadys Pharmaceuticals Inc., of San Diego, reported positive interim data from a Phase II trial of ANA380 in patients infected with lamivudine-resistant hepatitis B virus at the Asian Pacific Association for the Study of the Liver in New Delhi, India. After 12 weeks of treatment, patients receiving 30-mg and 60-mg doses of ANA380 showed an average DNA viral load reduction of 2.8 and 3.2 log10 units, respectively. Interim data from the 90-mg cohort showed an average viral load reduction of 2.7 log10 units after four weeks. The data also showed that administration of ANA380 was well tolerated and safe. ANA380 is an oral prodrug of ANA317, a nucleotide analogue that has exhibited activity against HBV, the company said.

• MediBIC, of Tokyo, and DNA 2.0 Inc., of Menlo Park, Calif., formed a collaboration in Japan focused on protein engineering and gene synthesis. The relationship will integrate the capabilities of each company in the areas of bioinformatics, data analysis, machine learning algorithms and gene synthesis to support the work of genomic drug discovery and research science. Under terms of the agreement, MediBIC will collaborate with DNA 2.0 in new product research and development, and it will be the sole Japanese distributor for DNA 2.0's existing repository of synthesized genes.

• Oxford Biomedica plc, of Oxford, UK, licensed its retroviral gene delivery technology to MolMed SpA, of Milan, Italy.

• Pharmagene plc, of Royston, UK, reached an agreement with Bayer Healthcare AG, of Leverkusen, Germany, to restructure their relationship. Bayer recently realigned its research focus, and certain compounds in advanced preclinical development that now fall outside its core research interests will be evaluated by Pharmagene, which will have the right to negotiate terms for further development and commercialization. Bayer also withdrew from its custom-validation agreement with Pharmagene, but will continue to use Pharmagene's human tissue-validation services on an ad hoc basis.

• Prana Biotechnology Ltd., of Melbourne, Australia, announced that 9.5 million unlisted options expiring on Dec. 1 were exercised prior to that date. The options originally were largely owned by certain insiders and directors of the company then transferred to new owners, who, in turn, exercised them at a price of A$0.50 (US$0.38) per share. Prana focuses on research into Alzheimer's disease and other age-related degenerative disorders.

• ProStrakan Group Ltd., of Galashiels, UK, and Cellegy Pharmaceuticals Inc., of South San Francisco, entered an exclusive agreement for the commercialization of Rectogesic in Europe. The product is known as Cellegesic in the U.S., and it is a 0.4 percent topical nitroglycerin ointment indicated to treat pain associated with chronic anal fissures. The product was approved by UK authorities in September. Under terms of the agreement with ProStrakan, Cellegy could receive up to $5.6 million in up-front and milestone payments, including payments if the product later is approved to treat hemorrhoids. Cellegy also is entitled to an amount in excess of 25 percent of net sales of Rectogesic in Europe, including costs of goods. ProStrakan is responsible for additional regulatory filings, sales, marketing and distribution of Rectogesic throughout Europe.

• Protherics plc, of Runcorn, UK, changed the manufacturing process for its polyclonal antibody CytoFab, for the treatment of septic shock. That has reduced production costs and, armed with FDA approval for the new process and an approved Phase III trial design, the company now is in talks with potential partners.

• Provalis plc, of Deeside, UK, signed an option agreement with Aventis Pasteur, the vaccines business of the Sanofi-Aventis Group, of Paris, for the development of vaccine candidates to prevent Streptococcus pneumoniae infection. Aventis was granted a 24-month exclusive option to evaluate Provalis' protein-based antigen vaccine candidates to prevent S. pneumoniae infection. Aventis Pasteur will pay an initial option fee to Provalis and will pay all costs, back-dated to May 2004, connected with the patients relating to those vaccine candidates.

• Sinovac Biotech Ltd., of Beijing, began listing its common stock as "SVA" on the American Stock Exchange. The company, which is developing vaccines for infectious illnesses such as hepatitis A and B, influenza and severe acute respiratory syndrome, is the second mainland China-based firm to list on the exchange this year. Sinovac is conducting clinical trials on a SARS vaccine. Separately, Sinovac entered a share purchase agreement with China Bioway Biotech Group Co. Ltd., Beijing Keding Co. Ltd. and Shenzhen Bio-Port Co. Ltd. to purchase about 20.6 percent of Sinovac. The closing date is set for Dec. 30, or on such earlier or later closing date as may be agreed to in advance and in writing by each of the parties. Also, Sinovac said its severe acute respiratory syndrome vaccine has induced SARS-neutralizing antibodies in tests of the human volunteers' blood serum. After a 56-day observation period, 11 out of 12 volunteers who received high-dosage vaccine, and 12 out of 12 who received low-dosage vaccine, showed blood serum conversion. The conversion indicates the ability of the induced antibodies to neutralize the SARS virus.

• TheraSTrat, of Allschwil, Switzerland, entered a worldwide exclusive commercialization agreement to use its SafeBase Knowledge Base with Discovery Partners International Inc., of San Diego, to help enhance DPI's lead identification, selection and optimization programs. SafeBase will provide drug safety-relevant knowledge to find candidates for preclinical and clinical development. By using knowledge obtained from compounds that have caused serious safety problems for individuals carrying single allelic variants or related haplotypes, the companies will try to enhance the safety of lead compounds.

• Transgene SA, of Strasbourg, France, appointed Philippe Archinard CEO and board director, replacing Jean-Francois Carmier, who is leaving the company for personal reasons. Since March 2000, Archinard served as CEO of Innogenetics NV, of Ghent, Belgium. Before that he held various positions for 15 years with Paris-based bioMerieux. Transgene's board said the company's principal shareholders will cover Transgene's cash needs until the end of 2005, giving the new CEO time to develop and implement his strategy.

• Vaxon-Biotech, of Evry-Genopole, France, completed the Phase I trial of its vaccine, VX-001, which was conducted at Heraklion University in Greece. VX-001 was well tolerated, stimulated T-cell immunity, and showed clinical benefits in patients. It contains hTERT572Y, a single optimized cryptic peptide that targets tumors expressing the telomerase antigen. The trial involved 19 patients with advanced-stage metastatic cancer of different types that progressed despite chemotherapy.

• The Wales College of Medicine at Cardiff University said its cancer and cell-aging researchers secured more than £15 million (US$28 million) to study cancer and DNA damage. The funding is expected to aid in their studies of unraveling the complexities of how cells maintain their chromosomes, how the repair of DNA in cells is influenced by chromosome structure and to analyze components in DNA-repair complexes.

• Zellera AG, of Berlin, appointed Gunter Rosskamp as the company's managing director. The company is a subsidiary of Aastrom Biosciences Inc., of Ann Arbor, Mich., and specializes in tissue-regeneration applications. Rosskamp previously held management and executive positions with Schering AG, of Berlin, and worked as CEO of Revotar Biopharmaceuticals AG, also of Berlin.

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