• Acrongenomics Inc., of Athens, Greece, launched its Nano-JETA Real Time PCR Pilot kits for DNA/RNA quantification with the use of beta-globin and Ep-CAM gene, respectively. The Real Time PCR delivers quantitative detection of nucleic acids from the second cycle up to the 13th cycle.

• Altana AG, of Bad Homburg, Germany, said its Daxas (roflumilast) collaboration with Pfizer Inc., of New York, was mutually terminated. As a result, Pfizer returned all rights to the phosphodiesterase 4 (PDE4) inhibitor to Altana, which will assume sole responsibility for its development, including ongoing clinical studies. At the same time, Altana said top-line results from a one-year study in chronic obstructive pulmonary disease (COPD) showed that the drug significantly improved lung function compared to placebo, the primary endpoint. Specifically, Daxas treatment was associated with 39 +/- 12 ml (p=0.0005) and 48 +/- 9 ml difference from placebo using a full longitudinal data analysis, respectively (p<0.0001). The study included 1,513 patients with severe and very severe COPD. A co-promotion agreement with Pfizer on Detrol will continue under its current terms until the end of next year.

• AnalytiCon Discovery GmbH, of Potsdam, Germany, entered an alliance with Evolva Biotech SA, of Allschwil, Switzerland, to generate and optimize nuclear receptor agonists and related compounds. Evolva will create and optimize the agonists, while AnalytiCon will be responsible for compound de-replication, identification and scale up. Financial terms were not disclosed.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the second Phase III induction trial of Tysabri (natalizumab) in moderately to severely active Crohn's disease in patients with evidence of active inflammation met its primary endpoint of clinical response as defined by a 70-point decrease, as measured at weeks eight and 12 using the Crohn's Disease Activity Index. In addition, Tysabri met all secondary endpoints in the ENCORE trial, and there were no notable differences in the rates of adverse events between the Tysabri and placebo treatment groups. All patients enrolled in the ENCORE trial completed dosing prior to the voluntary market withdrawal of Tysabri in February by Biogen and Elan, due to a possible link to two cases of progressive multifocal leukoencephalopathy, a potentially fatal nervous system disease. Researchers continue to investigate safety issues relating to Tysabri.

• Cellectis SA, of Paris, signed a license agreement with Xenogen Biosciences Corp., a subsidiary of Alameda, Calif.-based Xenogen Corp., granting it nonexclusive worldwide rights to its patented process covering the specific replacement or insertion of a gene in a eukaryotic genome. The deal will enable Xenogen to create and develop genetically engineered mice as part of its knock-in mice production activities, as well as develop custom animal models and related technologies. Financial terms were not disclosed.

• Cenix BioScience GmbH, of Dresden, Germany, and the Instituto de Medicina Molecular in Lisbon, Portugal, initiated a collaboration to identify human genes required for the malaria infection process, using systematic genome-scale RNAi screening. Financial terms were not disclosed.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, and Stragen Pharma SA, of Geneva, entered an alliance to develop Ceflatonin, ChemGenex's lead cancer therapeutic. ChemGenex will be responsible for its global clinical development and registration and marketing in North America and the Asia-Pacific region. Stragen will be responsible for drug production and global supply, as well as facilitating regulatory approvals in Europe. Once Ceflatonin is approved in Europe, the partners would market the product under the ChemGenex brand and share sales profits in that territory, with Stragen getting 51 percent and ChemGenex 49 percent. The drug is in Phase II testing at the M.D. Anderson Cancer Center in Houston, treating chronic myeloid leukemia patients who are resistant to Gleevec (Novartis AG). Also, Ceflatonin has established clinical activity in other hematological malignancies including myelodysplastic syndrome and acute myeloid leukemia.

• Chronogen Inc., of Montreal, and Inpharzam Richerche, of Taverne, Switzerland, a subsidiary of Zambon SpA, entered a research and development agreement to identify small molecules for the treatment of cardiovascular and metabolic diseases induced by oxidative damage and/or lipid disorders. Chronogen will screen the library of Inpharzam using its in vivo screening assays.

• Eporgen Venture SpA, of Turin, Italy, said it is providing the bulk of private capital for six start-up companies as result of a joint project called Discovery, carried out with Bioindustry Park Canavese SpA. Investments totaled €3 million in private capital and €2.7 million in public money for the new companies - BioNucleon, Biopaint, Eicosamed, Narvalus, Spider Biotech and Target Heart. They are based in the Bioincubator facility, which was created by the Bioindustry Park, and Eporgen holds between 60 percent and 76 percent of each company.

• Evotec AG, of Hamburg, Germany, appointed Tim Tasker executive vice president for clinical development. Tasker will lead the company's clinical development activities. He comes from GlaxoSmithKline plc, where he was vice president global clinical units, clinical pharmacology and discovery medicine.

• ExonHit Therapeutics SA, of Paris, added a fifth array product to its SpliceArray Service business unit with the addition of Cytokine SpliceArrays.

• GeneMax Corp., of Vancouver, British Columbia, received its lead vaccine candidate, AdhTAP (OS-1) from its PER.C6 technology licensor and contract manufacturer, Crucell NV, of Leiden, the Netherlands. The adenovirus construct has been optimized to allow enhanced expression of the transporter of antigen processing that, in animal models, has been shown to increase both the killing of tumors by the immune system and animal survival.

The German Ministry for Education and Research committed €10 million (US$11.9 million) to research the effects of plant resistance to antibiotics and herbicides brought about through genetic modifications. The funding will support 24 projects over the next three years.

• GPC Biotech AG, of Martinsried, Germany, began a Phase I trial of satraplatin, the company's lead candidate, in combination with Taxotere in patients with advanced solid tumors. Satraplatin already is in a Phase III trial for patients with hormone-refractory prostate cancer. The Phase I trial will assess toxicity, determine tolerated doses and recommend dosages for a Phase II trial of the combination. The trial is being undertaken with the University of Wisconsin Comprehensive Cancer Center in Madison.

• Intercell AG, of Vienna, Austria, and the Statens Serum Institute in Copenhagen, Denmark, gained support from the Aeras Global TB Vaccine Foundation for the development of a new prophylactic tuberculosis vaccine. Aeras will fund the development and subsequent clinical trials in return for a sub-license for developing countries with urgent medical needs and low standards of living. For the rest of the world, Intercell and SSI will retain joint marketing and profit-sharing rights. Terms were not disclosed. Also, Intercell said Sanofi Pasteur SA, the vaccines business of Paris-based Sanofi-Aventis Group, exercised its option on exclusive worldwide commercial rights on certain bacterial vaccine antigens identified by Intercell. The option brings Intercell research funding and success fees to about €3 million (US$3.6 million). Intercell is entitled to additional milestone-based payments, reaching up to €20 million, plus royalties.

• KeyNeurotek AG, of Magdeburg, Germany, a developer of drugs for degenerative disorders of the central nervous system, closed an exclusive license agreement with Bayer Healthcare AG, of Leverkusen, Germany. KeyNeurotek will proceed with the further clinical development and marketing of Bayer's compound Bay 38-7271 for traumatic brain injury.

• MediGene AG, of Martinsried, Germany, said results of a Phase II trial of its Polyphenon E Ointment (15 percent) for the treatment of actinic keratosis, a precursor of skin cancer, showed that the drug demonstrated immunomodulatory properties, though the chosen treatment regimen and trial length were not sufficient for complete healing of all visible skin lesions on patients' scalps and faces. The company said it plans to continue with clinical development after determining an optimal dosage plan.

• MerLion Pharmaceuticals Pte. Ltd., of Singapore, and the Institute of Molecular and Cell Biology in Singapore entered a three-year drug discovery and development collaboration in which the institute will provide the company with a series of selected drug targets and projects. MerLion will provide access to its natural products sample collection and apply its screening and natural products chemistry processes to the isolation of new chemical leads and drug candidates. It also will supply its medicinal chemistry in the optimization and preclinical development of active chemical templates. The deal's initial focus will center on identifying potential cancer drug candidates based around the Bcl-2 family of proteins. The partners will work together on lead discovery and optimization and share ownership of the output.

• Morphochem AG, of Munich, Germany, reached a milestone in its research collaboration with The Genetics Co., of Zurich, Switzerland, by illuminating the structure of ß-secretase. The Genetics Co. is optimizing compounds that inhibit ß-secretase as part of the firm's Alzheimer's program. Financial terms related to the milestone were not disclosed.

• Neurochem International Ltd., of Ecublens, Switzerland, said the FDA agreed to file and review a new drug application for Fibrillex that would include efficacy and safety data from a single Phase II/III trial. The investigational product candidate, developed for treating amyloid A amyloidosis, is the subject of an exclusive collaboration and distribution agreement with Centocor Inc., of Malvern, Pa. The regulatory news follows a recent meeting with the FDA's cardio-renal division to discuss results of that Phase II/III trial, and the agency encouraged Neurochem to look at and provide additional follow-up data collected from the open-label extension study as part of its submission. The company is a wholly owned subsidiary of Neurochem Inc., of Laval, Quebec.

• NeuroSolutions Ltd., of Sydney, Australia, and Sosei Co. Ltd., of Tokyo, said they identified a candidate for neuropathic pain, the result of a year-old collaboration that brought together Sosei's Drug Reprofiling Platform (DRP) and NeuroSolutions' drug activity assay platforms. Labeled DRP-043 by Sosei and NSL-043 by NeuroSolutions, it originally was developed in Japan for a different indication but was terminated by its originator due to a lack of advantage at a late clinical stage. Intellectual property rights will be shared, and NeuroSolutions intends to raise funds to co-develop the compound with Sosei.

• NV Organon, of Oss, the Netherlands, agreed to collaborate with Cypress Bioscience Inc., of San Diego, to develop and commercialize a treatment for obstructive sleep apnea. The collaboration will involve an enantiomer of mirtazapine, ORG 4419, and combinations of mirtazapine with another approved drug to augment efficacy and improve tolerability. The companies jointly will select a development candidate based upon proof-of-concept trials, and then share costs and responsibility for further clinical activities. Further financial terms were not disclosed. In other news, Organon announced a global biotechnology discovery research initiative with a Boston seminar, and opened the doors to its new Cambridge, Mass.-based research center June 29.

• Oxford BioMedica plc, of Oxford, UK, said the patent office of the People's Republic of China granted two patents on its lentiviral gene vectors. The company plans to go ahead with commercializing the products in the Chinese market.

• Pharming Group NV, of Leiden, the Netherlands, is partnering with AgResearch Ltd., of Hamilton, New Zealand, on the production of recombinant human lactoferrin (rhLF). AgResearch, which will be responsible for the production of rhLF and will provide access to its purification and research capabilities for product development, will bear costs associated with rhLF's initial production and support its commercialization in the South Pacific and Asia. At the same time, Pharming granted AgResearch a research license to its recombinant protein production technology. In return, Pharming will have the first right to review new products from AgResearch's protein discovery and development projects. Pharming's commercial rights will include recombinant bovine and human proteins produced using its technology.

• Pharmos Corp., with offices in Iselin, N.J., and Rehovot, Israel, reported the initiation of a clinical program to commercialize its NanoEmulsion drug delivery technology. The company plans to initiate a Phase I/II feasibility clinical trial before year-end. The study will evaluate safety, pharmacokinetics and the analgesic effect of an approved non-steroidal anti-inflammatory drug formulated in its NanoEmulsion in patients with osteoarthritic pain in the knee.

• Qiagen NV, of Venlo, the Netherlands, entered an agreement to acquire Nextal Biotechnology Inc., of Montreal, in exchange for $9.7 million in cash. An additional consideration of about $4.5 million is subject to certain milestones. Nextal provides sample-preparation tools that make protein crystallization more accessible, while Qiagen sells preanalytical sample preparation products enabling genetic and protein analysis. Gargoyle Partners LLP is acting as Qiagen's exclusive financial adviser.

• Sareum Holdings, of Cambridge, UK, reached a milestone in its collaboration with an unnamed UK central nervous disease system specialist, elucidating the 3-dimensional structure of a protein target in complex with drug and potential drug targets that inhibit its action. That triggers the first milestone payment under the agreement signed in December.

• Tecan Schweiz AG, of Mannedorf, Switzerland, and BioDiscovery Inc., of El Segundo, Calif., entered a collaboration to offer a data-management solution to interpret and verify microarray results. The collaboration is based on direct integration of data collected by Tecan's HS series of automated hybridization stations with BioDiscovery's GeneDirector microarray data management software.

• Teva Pharmaceuticals Industries Ltd., of Jerusalem, and Active Biotech AB, of Lund, Sweden, submitted an investigational new drug application to the FDA to initiate a trial in the U.S. with laquinimod to assess drug-drug interaction. Laquinimod is an orally administered immunomodulatory substance, developed by Active Biotech and recently licensed to Teva.

• UK legislation to combat animal rights extremism has been enacted. The laws introduce a new offense of harassment of a person in his or her home, and give the police additional powers. It also becomes an offense to target any scientist, research facility, or company in the supply chain of an animal research organization with a campaign of criminal damage, trespass, blackmail or libel. The offense carries a penalty of up to five years in prison and an unlimited fine.

• York Pharma plc, of Hitchin, UK, received approval for a Phase II study of YP003 for the treatment of psoriasis. Dosing in the Australian study will begin shortly and is expected to complete by the end of 2005. YP003 is topically applied and targets an unnamed enzyme that acts as a regulator of cellular proliferation and occurs in psoriatic lesions but not in normal skin.

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