• Active Biotech AB, of Lund, Sweden, disclosed the final report of its Phase IIa study of TTS (Tumor Targeted Superantigens) CD2 in patients with advanced pancreatic cancer. Of the 19 subjects enrolled in the study, five exhibited stable disease after two months, and median survival time was 148 days. The next generation of the treatment, TTS CD3, is in a Phase I trial in non-small-cell lung carcinoma.

• Affibody AB, of Stockholm, Sweden, and Finnzymes Oy, of Espoo, Finland, entered a collaboration in which Affibody will develop specific affibodies - high-affinity protein ligands that mimic the binding properties of antibodies - for incorporation into Finnzymes' PCR kits. The affibodies will be developed to inhibit the action of the polymerase enzyme used in the kits, which Finnzymes will market. Affibody will receive undisclosed milestones and royalties, as well as payments for the ligands it supplies.

• Benitec Ltd., of Queensland, Australia, initiated patent-infringement lawsuits in the U.S. District Court for the District of Delaware against Nucleonics Inc., of Malvern, Pa.; Ambion Inc., of Austin, Texas; and Genscript Corp., of Piscataway, N.J. to protect its gene-silencing technologies. The lawsuit alleges that the three companies are infringing issued U.S. Patent No. 6,573,099.

• BioTie Therapies Oyj, of Turku, Finland, said the county government of Western Finland rejected an application by certain minority shareholders for a special audit. The application, filed July 17, 2003, related to the company's communications with the stock exchange, investors and the press, and issues surrounding a press release issued May 7, 2003, which outlined a new share issue.

• BioVex Ltd., of Oxford, UK, reported that the combination of its oncolytic agent, OncoVex, with first-line chemotherapeutic agents resulted in significant lowering of the dose of drug needed to achieve tumor-cell killing in preclinical models. OncoVex is an oncolytic virus that selectively replicates in and kills tumor cells, leaving normal tissue unharmed. In tumor models in vitro, studies demonstrated that the concentrations of cisplatin or taxol required for tumor-cell killing could be reduced (more than 100-fold) when combined with low, otherwise subtherapeutic doses of OncoVex.

• The Cambridge-MIT Institute, a joint venture between Cambridge University, UK, and the Massachusetts Institute of Technology in the U.S., launched a Next Generation Drug Discovery Community, to tackle bottlenecks in the drug discovery process. The community will involve academic researchers in a range of disciplines, along with partners from the information technology, pharmaceutical and biotechnology industries. IBM Life Sciences and AstraZeneca plc were the first to sign up. The aim is to move away from the one-gene, one-protein, one-drug approach to applying a systems-level view of life and disease processes to drug discovery.

• Can-Fite BioPharma Ltd., of Petach-Tikvah, Israel, presented interim results from the Phase II trial of CF101 for colorectal cancer, at the 95th meeting of the American Association for Cancer Research in Orlando, Fla. The double-blind study tested three doses of CF101 in patients with metastatic colorectal cancer and showed that CF101 is a specific and effective agonist against the A3 adenosine receptor. Thirty-six percent of the 56 evaluable patients had stable disease and continued on the study after eight weeks. Six patients were stable at eight weeks, six were stable after 16 weeks and two remained stable after 24 weeks.

• Cerep SA, of Paris, reported a drop in its consolidated net profit to €0.46 million in 2003 from €3.2 million in 2002. Revenues were virtually unchanged at €34.1 million, although there would have been a 9.3 percent increase in the absence of currency fluctuations. Service income, in particular, rose by 16 percent to €29.5 million (and would have shown an increase of nearly 29 percent on a constant currency basis). For 2004, Cerep is forecasting a 45 percent rise in sales revenues.

• Crucell NV, of Leiden, the Netherlands, and the Aeras Global TB Vaccine Foundation in Bethesda, Md., reported a new collaboration on the preclinical and clinical development of candidate tuberculosis vaccines. Aeras agreed to provide Crucell up to $2.9 million contingent on meeting certain development milestones, for development of TB vaccine candidates. The Crucell-Aeras TB vaccine program will focus on improvement of the only currently available TB vaccine, Bacillus Calmette-Guerin, using Crucell's PER.C6 and AdVac technologies. With the collaboration, Crucell's early stage TB vaccine development is funded up to entering the clinic, it said.

• Debiopharm SA, of Lausanne, Switzerland, received approval in Germany of Pamorelin LA (long-acting) 11.25 mg to treat prostate cancer. The product is manufactured at Debio RP in Martigny, Switzerland, using the Debio PLGA technology. Debio RP will supply its partner Ipsen SA, of Paris, with commercial quantities of Pamorelin LA to be marketed in Germany. Debiopharm will receive milestone payments for the registration, as well as royalties on sales of the product.

• D-Pharm Ltd., of Rehovot, Israel, said in vivo results published in the online edition of Neurobiology of Aging demonstrates the effect of DP-109 in reducing amyloid pathology in the brains of human beta-amyloid precursor protein transgenic mice. More specifically, daily oral administration of the lipophilic metal ion modulator for three months markedly reduced the burden of amyloid plaques and the degree of cerebral amyloid angiopathy in brains, compared to animals receiving vehicle treatment. Moreover, DP-109 treatment facilitated the transition of amyloid-beta from insoluble to soluble forms and the moderation of brain inflammation characteristic of Alzheimer's disease.

• EpiTan Ltd., of Melbourne, Australia, said that, following a review of its clinical strategy in Europe, it will be expanding its clinical trials for polymorphous light eruption, otherwise known as sun poisoning, during 2004. The company will lodge a Clinical Trial Exemption application with the European Medicines Evaluation Agent to expand the number of PMLE trial sites in Europe to include the UK and Sweden. The company's current German PMLE proof-of-concept study will be deferred, despite receiving ethics committee approval, to facilitate the expansion and to allow the use of the new lower-dosage, sustained-release solid injectable, which will be used in place of the larger implant.

• Evotec Neurosciences GmbH, of Hamburg, Germany, acquired from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, an exclusive worldwide license to develop and market NMDA-receptor NR2B subtype selective antagonists for the treatment of central nervous system disorders, such as neuropathic pain, and Alzheimer's and Parkinson's diseases. Financial details were not disclosed. The compounds are in late-stage preclinical development and show an improved side effect profile compared to non-selective NMDA-receptor antagonists. Evotec Neurosciences is a subsidiary of Evotec OAI AG, which also announced a medicinal chemistry collaboration with Panacos Pharmaceuticals Inc., of Gaithersburg, Md. Panacos will use Evotec's capabilities to identify drug candidates to treat HIV. Panacos recently began Phase I trials of its small-molecule HIV drug candidate PA-457.

• Genmab A/S, of Copenhagen, Denmark, said that HuMax-CD4 was designated a fast-track product by the FDA. The designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed available therapy. The patient group includes those who are refractory, as well as those who cannot tolerate available treatment. HuMax-CD4 is in two Phase II studies to treat CTCL. HuMax-CD4 is a high-affinity human antibody that targets the CD4 receptor on T lymphocytes.

• GPC AG, of Martinsried, Germany, reported positive results from its three most advanced drug development programs at the American Association for Cancer Research's annual meeting in Orlando, Fla. Data showed its lead cell-cycle inhibitor compound - RGB-286199 - results in cell-cycle arrest and apoptosis in a range of tumor cells in culture. GPC said the compound's role in inhibiting certain kinases suggested that it could be effective against a range of cancer targets. The company also presented results for satraplatin, its lead compound, which is in a Phase III registrational trial. Those data showed that hormone-refractory prostate cancer cells were particularly sensitive to the compound. Finally, GPC presented preclinical data showing the effectiveness of a monoclonal antibody, designated 1D09C3, against a variety of hematological malignancies. One study showed that 1D09C3 together with the cancer drug Rituxan was more effective against a non-Hodgkin's lymphoma model than either drug alone.

• Immuno-Designed Molecules SA, of Paris, launched a Phase II/III trial of Bexidem, its cell therapy for bladder cancer. The product consists of activated macrophages obtained from the patient's white blood cells. The trial is being conducted in Europe, mainly in France, Germany and Luxembourg, and the intermediate results on the first 138 patients will be used to determine the number of patients enrolled in the Phase III trial.

• Medivir AB, of Huddinge, Sweden, and Peptimmune Inc., of Cambridge, Mass., said they selected an orally active, small-molecule inhibitor of the protease enzyme Cathepsin S as a drug candidate. The partners said they would begin late-stage preclinical studies designed to support an investigational new drug application. The companies said Cathepsin S is a protease that plays a significant role in the activation of certain immune responses.

• Merck KgaA, of Darmstadt, Germany, and its partner ImClone Systems Inc., of New York, reported that the European regulatory agency recommended approval of ImClone's cancer drug, Erbitux (cetuximab), in combination with irinotecan in the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer after failure of irinotecan-based cytotoxic therapy. The recommendation came from the scientific advisory body of the European Agency for the Evaluation of Medicinal Products. Merck said that no specific post-approval obligations are required. Erbitux was first launched in Switzerland in December for use in combination with irinotecan.

• Micromet AG, of Munich, Germany, promoted Christian Itin from chief business officer to CEO. Itin succeeds Erich Felber, a co-founder of the company and CEO since its launch, who will continue as the company's president and a member of its executive board. Itin joined Micromet in 1999 from Zyomyx Inc., of Hayward, Calif., a protein chip company he co-founded. Following his doctorate in cell biology, Itin worked in research positions at the University of Basel and Stanford University. Micromet also signed a global, nonexclusive license granting Arizeke Pharmaceuticals Inc., of San Diego, use of Micromet's single-chain antibody intellectual property for developing and commercializing Arizeke's drug delivery technology. Arizeke will make an up-front payment and pay annual maintenance fees, as well as milestones and, potentially, royalty payments. The companies declined to specify the size of the payments.

• Mtm Laboratories, of Heidelberg, Germany, added three members to its supervisory board. Erich Platzer is an investment adviser with HBM Partners AG, of Zurich, Switzerland, and the former director of strategic marketing for Roche's oncology department. Platzer is also chairman of the supervisory board of Ingenium Pharmaceuticals AG, of Munich, Germany. Werner Schaefer is an adviser and consultant. Previously he +was a senior manager for Roche Diagnostics GmbH and Abbott Diagnostics GmbH. Rainer Strohmenger is a partner with Wellington Partners in Munich, Germany. Mtm concentrates on products for the early detection of cancer.

• Munich Biotech AG, of Munich, Germany, said results were presented during a congress of clinical investigators involving Phase I studies of MBT-0206 in cancer patients. Results indicated that patients continuing with MBT-0206 beyond the trial period on compassionate grounds showed quality-of-life improvements, stabilization and, in some cases, tumor regression. No cytotoxic side effects or drug resistance were recorded. That profile differentiates MBT-0206, an antineovascular therapy, from most other chemotherapies, the company said. MBT-0206 specifically targets tumor endothelial cells and inhibits vascularization of the tumor.

• Nautilus Biotech, of Paris, said it successfully completed comparative monkey studies between its IFNalpha (Belerofon) and two commercial IFNalpha drugs, native IFNalpha and pegylated IFNalpha. Among the results, the company found that preliminary dose-escalation and repeated-dosing studies of Belerofon in monkeys have shown an absence of adverse clinical or hematological events associated with treatment. Pharmacodynamic studies using surrogate markers indicate that Belerofon is active in vivo and that it triggers the appropriate biological response. Its pharmacokinetic profile outperformed those for non-pegylated, commercial IFNalpha and compared favorably with those obtained for commercial, pegylated IFNalpha in all parameters measured. It also required lower dosing levels.

• NeuroSearch A/S, of Ballerup, Denmark, gained a 14.7 percent stake in PainCeptor Pharma Corp., of Montreal, in exchange for transferring certain patent rights and know-how. NeuroSearch received about DKK3.5 million (US$580,000) as repayment of a convertible loan granted to PainCeptor, which recently was formed via a merger and raised about $17.3 million in the process.

• Novartis AG, of Basel, Switzerland, completed a feasibility study on a potential combination with Aventis SA, of Strasbourg, France, concluding that a business case is viable. But Novartis said a negative attitude from the French government has influenced its consideration to a point that it would only enter a negotiation phase if formally invited by the Aventis board, and if the French government assumed a neutral position. Novartis added that neither negotiations nor discussions about price have taken place. Recently, Aventis has been the subject of a takeover bid by Sanofi-Synthelabo SA, of Paris.

• Ozgene Pty. Ltd., of Perth, Australia, was awarded an $8.5 million contract from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., to supply genetically modified mice to individual investigators in the institute.

• Peplin Biotech Ltd., of Brisbane, Australia, filed three separate investigational new drug applications with the FDA for a topical formulation of its lead compound, PEP005. The INDs are for the treatment of the pre-cancerous condition actinic keratosis, as well as basal-cell carcinoma and squamous-cell carcinoma. The filings were made under a collaboration with Allergan Inc., of Irvine, Calif., triggering a $1 million payment to Peplin.

• PPL Therapeutics plc, of Edinburgh, UK, sold the New Zealand farm where it raised its transgenic sheep for £1.13 million (US$2.1 million), as it continued to dispose of its assets. That leaves the company, which created Dolly the cloned sheep, with just its Fibrin-1 wound-sealant technology, a pilot manufacturing plant and some intellectual property relating to its transgenic programs. PPL is in discussions that might lead to the sale of the remainder of the company, and says it is also considering terminating its Fibrin-1 license to minimize liabilities. Following the sale of the farm, the number of employees will be reduced from seven to four.

• RNAx GmbH, of Berlin, signed a distribution agreement with Funakoshi Ltd., of Tokyo, related to RNAx's services for the validation of siRNA oligonucleotides and genetic targets based on RNA interference technology. Funakoshi will act as exclusive agent for RNAx in Japan, promoting RNAx's services in the Japanese market. Financial terms were not disclosed.

• Serono SA, of Geneva, and IVAX Corp., of Miami, reported positive results from two clinical trials of an oral formulation of cladribine, a potential treatment for multiple sclerosis. The data showed that oral cladribine met the targets for an orally administered product, with blood levels of cladribine in the expected therapeutic range. Efficacy studies are planned to start late this year. Previous Phase II and III trials have demonstrated the positive effect of injectable cladribine in multiple sclerosis patients, resulting in a reduction in new lesion development in the brain as seen on magnetic resonance imaging scans.

• Sinovac Biotech Ltd., of Beijing, said it began a research and development program on an inactivated human influenza vaccine for avian flu (H5N1). The company expects to finish preclinical research by the end of this year. The vaccine is produced through the steps of manual cultivation, propagation, inactivation, purification and splitting the virus strain.

• Solexa Ltd., of Essex, UK, and Lynx Therapeutics Inc., of Hayward, Calif., reported the joint acquisition from Manteia SA, of Coinsins, Switzerland, of the rights to technology assets for DNA colony generation. The technology assets feature a process to enable parallel amplification of millions of DNA fragments, each from a single DNA molecule, to create DNA colonies or clusters. For Lynx, the planar cluster technology, when fully developed, will replace its Megaclone technology, a process that transforms a sample containing millions of DNA molecules into one made up of millions of micro-beads coated with DNA. Terms of the transaction were not disclosed.

• Tripep AB, of Huddinge, Sweden, said shareholders at its annual general meeting authorized the company to seek a parallel listing of its shares on the Alternative Investment Market of the London Stock Exchange. Its shares are already listed on the Stockholm Stock Exchange.

• Vakzine Projekt Management GmbH, of Braunschweig, Germany, began a program to develop a new tuberculosis vaccine researched by the Max Planck Institute for Infection Biology in Berlin. VPM was founded by Germany's Ministry for Education and Research, as part of a national vaccine initiative. The company will manage the preclinical and clinical studies in the tuberculosis program, together with the German Research Center for Biotechnology also in Braunschweig. The proposed vaccine builds on the live BCG vaccine, which has been used since 1921, while adding gene coding for a protein that perforates the phagosomes, which usually shield BCG bacteria from immune response. VPM aims to bring the vaccine through Phase II clinical testing, and then seek licensing partners.

• Xcellsyz Ltd., of Newcastle, UK, was granted a nonexclusive license from Geron Corp., of Menlo Park, Calif., to Geron's telomerase reverse transcriptase technology for research applications and the development of research products. Xcellsyz will use hTERT to create immortalized cell lines for in vitro use in drug discovery and screening. The license is limited to cell lines that also include a recombinant, conditionally inducible oncogene, using Xcellsyz's own technology. Geron will receive a license fee in cash and equity in Xcellsyz, as well as potential royalties.