• Amersham plc, of Buckinghamshire, UK, reported the in-licensing of a class of molecules from the University of Pittsburgh in Pennsylvania targeting amyloid plaques in the brain. Amersham's strategy is to identify a lead candidate for clinical evaluation as a positron emission tomography diagnostic and monitoring agent for Alzheimer's disease. Financial terms of the agreement have not been disclosed. Other molecules in the class also will be used by Amersham's pharmaceutical partners through its Imanet network of imaging research centers to accelerate and facilitate the development of therapeutic drugs that target Alzheimer's disease.

• Antisoma plc, of London, said it completed recruitment in a Phase I dose-ranging study of its small-molecule vascular targeting agent, AS1404, in solid tumors. It is the third Phase I study of the product, which works by selectively disrupting established tumor blood vessels. Animal studies indicate that AS1404 enhances the effect of conventional therapy, and Antisoma is planning further trials in 2004 in combination with radiotherapy and chemotherapy.

• Australian Cancer Technology, of Perth, Australia, entered a partnership agreement with the Telethon Institute for Child Health Research (TICHR) in Perth, which developed a test that can detect the loss of genes in cancer cells, paving the way for more targeted and effective treatments for patients, it said. The head of the Children's Leukemia and Cancer Research Division at TICHR, said the development of a fast, simple gene test could improve patient outcomes.

• Avecia Biotechnology Inc., of Billingham, UK, said its DNA medicines production facility in Grangemouth, Scotland, received European Union certification to produce DNA-active pharmaceutical ingredients for clinical trials and commercial products.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, has taken its Humira royalty dispute with Abbott Laboratories, of Abbott Park, Ill., to the High Court in London. CAT is contesting Abbot's right to reduce the level of payments on the rheumatoid arthritis drug, which had sales of $161 million in the first nine months of the year. Abbott claims the terms of the license allow it to offset payments due to CAT against royalties due to third parties.

• Cobra Biomanufacturing plc, of Keele, UK, said it was granted a European patent for its device and methods for extracting and purifying plasmid DNA in large-scale manufacturing plants.

• Crucell NV, of Leiden, the Netherlands, presented efficacy results from a malaria vaccine at the Viral Vectors & Vaccines conference in Las Vegas. The study is part of a collaboration between Crucell and the Department of Medical and Molecular Parasitology at New York University to provide proof of principle that a vaccine based on Crucell's AdVac technology can protect against malaria. The study shows a single shot of a recombinant adenovirus 35 (rAd35) vector-expressing circumsporozoite protein protects mice from infection by the mouse malaria parasite Plasmodium yoelii.

• Cyclacel Ltd., of Dundee, UK, announced positive preclinical data on CYC202, a cyclin-dependent kinase (CDK) inhibitor, in two variants of the kidney disease glomerulonephritis. The company says the results show that CDK inhibitors can address cell proliferation diseases other than cancer, by disrupting cell division. CYC2002 is already in Phase IIa trials in breast and lung cancer, and those results underpin the rationale for Phase II trials in glomerulonephritis. Details of the studies were presented at the American Society of Nephrology meeting in San Diego.

• Cyprotex Ltd., of Macclesfield, UK, said it has validated its Cloe pharmacokinetics (PK) software in more than 150 compounds from seven pharmaceutical companies. The trials showed that Cloe PK can estimate how long a drug stays in the body, and is sufficiently accurate to be used to aid in the selection of compounds for clinical development. The company says the software provides similar PK information to that obtained in a Phase I trial and could be used to reduce the number of animals used in discovery research, while improving the chances that a compound will work in humans.

• De Novo Pharmaceuticals Ltd., of Cambridge, UK, announced Bart Wuurman is to be its new CEO. He joins the in silico drug design company from Antisoma plc where he was director of business development.

• DeCode Genetics Inc., of Reykjavik, Iceland, acquired an exclusive worldwide license to an investigational cardiovascular therapeutic called DG031 from Bayer AG, of Leverkusen, Germany. The small molecule is active against a key target, located within an inflammatory pathway, made by a gene isolated at DeCode that predisposes to myocardial infarction. Previous clinical work in a different indication has shown DG031 to be well tolerated with no major safety issues. DeCode plans to test it for efficacy in preventing heart attack in a Phase II trial, enrollment for which is expected to start at the beginning of next year. Bayer will receive milestones as the compound advances, as well as royalties on sales should the compound reach the market. More specific financial terms were not disclosed.

• Definiens AG, of Munich, Germany, began a partnership with Serva Electrophoresis, of Heidelberg, Germany, in which Serva will undertake the marketing of Definiens' products to life science research institutes and pharmaceutical companies. Definiens' products aim to automate precise evaluation of 2-dimensional gel arrays, particularly multiple iterations on a single gel. Serva sells related products. Financial terms were not disclosed.

• Elan Corp. plc, of Dublin, Ireland, said the holders of its Liquid Yield Option notes due 2018 have the right to surrender their notes for purchase through Dec. 15. Pursuant to the indenture, each holder can require Elan to purchase the notes at a price equal to $616.57 per $1,000 principal amount at maturity. The aggregate principal amount due at maturity for all outstanding notes is about $801.2 million, and if all are surrendered for purchase, the aggregate cash purchase price would be about $494 million.

• EpiTan Ltd., of Melbourne, Australia, said that, following a successful meeting with the FDA, the company expects to submit an investigational new drug application in mid-2004 and begin clinical trials shortly thereafter. An acceptable indication for Melanotan is expected to be for prevention or reduction of UV-induced skin damage in subjects at high risk (genetic or occupational). The IND will be for Melanotan in a sustained-release implant formulation.

• Gastrotech Pharma A/S, of Copenhagen, Denmark, appointed Claes Post CEO. Post is a professor of neuropharmacology at Karolinska Institute in Stockholm, Sweden. Post also has served as vice president, preclinical pain and inflammation research at AstraZeneca plc, of London. Gastrotech is focused on the medical application of gastrointestinal hormones.

• Genmab A/S, of Copenhagen, Denmark, and ACE BioSciences A/S, of Odense, Denmark, said they would develop an antibody therapeutic product to treat fungal infections. The antibody will be directed against a target on Aspergillus fumigatus. The target discovered by ACE is the first in the collaboration between Genmab and ACE that covers four commercially promising disease targets in the area of infectious diseases. In the deal, ACE provides commercially promising disease targets and Genmab provides human antibody technology to create and develop antibody products. The two companies share development costs and commercial rights equally.

• Igeneon AG, of Vienna, Austria, intends to start two pivotal trials for its cancer vaccine IGN101. The first, in metastatic colorectal cancer, will be a 700-patient, placebo-controlled Phase III conducted in 24 European centers. The other is a Phase III in adjuvant breast cancer, scheduled to be conducted in cooperation with the Austrian Breast & Colorectal Cancer Study Group. A Phase II/III trial in adjuvant non-small-cell lung cancer is ongoing. IGN101 is designed to trigger an immune response to EpCAM (epithelial cell adhesion molecule), a membrane protein that is almost always expressed - and often overexpressed - on epithelial cancer cells. It aims at the selective destruction of disseminated tumor cells and might prevent or delay the formation of metastases.

• Ion Genetics AG, of Munich, Germany, and Novoplant GmbH, of Gatersleben, Germany, entered a licensing agreement giving Novoplant access to Icon's platform for manufacturing immune response proteins in green plants. Novoplant said the platform will improve its position in animal health. Icon is active in both pharmaceutical and agricultural biotechnology, specializing in developing production hosts. Financial terms were not disclosed.

• Kemin Pharma, of Herentals, Belgium, reported the identification of carbohydrate-based molecules with highly effective and selective activity against human cytomegalovirus (CMT). The molecules are part of a new class being screened by Kemin Pharma that exhibit positive activity, selectivity and toxicity profiles, the company said. The company was able to chemically modify and optimize the lead molecule, creating molecule KPE1015, which Kemin said delivered improved in vitro activity, superior to ganciclovir, against both the Davis and AD-169 strains of CMV.

• Kourion Therapeutics AG, of Langenfeld, Germany, was acquired by ViaCell Inc., of Cambridge, Mass. Concurrent with the transaction, ViaCell received additional investment capital from Genzyme Corp., of Cambridge, Mass., MPM Capital, of Boston, and others. Kourion founders discovered the Unrestricted Somatic Stem Cell, a pluripotent stem cell found in human umbilical cord blood that they identified, isolated and expanded in culture. ViaCell said the acquisition provides it research and development programs in two new therapeutic areas - cardiac repair and orthopedic indications - along with intellectual property covering products for these and other therapeutic uses. Kourion CEO Stephan Wnendt will lead ViaCell's European operations in the role of senior vice president for that territory. Financial terms were not disclosed.

• Leica Microsystems, of Wetzlar, Germany, and Axaron Bioscience AG, of Heidelberg, Germany, agreed to co-market laser microdissection and gene expression analysis products and services. The agreement extends the companies' existing cooperation and also covers Leica's system for laser microdissection and Axaron's cell-specific transcription profiling. The companies aim to attract new clients from their complementary customer bases. Financial terms were not disclosed.

• Life Sciences Partners, a European venture capital firm located in Amsterdam, the Netherlands, and Munich, Germany, made an initial commitment to NeuroNova AG, of Munich, as part of a €14 million round of equity financing. NeuroNova is a biopharmaceutical company in the field of affective disorders. The company said the funding will enable it to pursue product acquisition and outlicensing options as well as to start its first collaborations with the pharmaceutical industry.

• Merck KGaA, of Darmstadt, Germany, said the Swiss Agency for Therapeutic Products has sent pre-notification of its intent to authorize marketing of Erbitux (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. Final approval is expected within 30 days. The Swiss authorization would be the first approval for Erbitux in the world, Merck said. It submitted applications at the end of June for approval in Switzerland and also to the European Agency for the Evaluation of Medicinal Products. An EU marketing authorization is expected in mid-2004. The drug also is on file in the U.S., with ImClone Systems Inc. and Bristol-Myers Squibb Co., both of New York, having submitted their package in August.

• Norwood Abbey Ltd., of Melbourne, Australia, signed an exclusive license arrangement for its immunology intellectual property with TAP Pharmaceutical Products Inc., of Lake Forest, Ill. Norwood's immunology intellectual property will be studied for use in the enhancement of an existing class of sex steroid drugs called GnRH analogues, of which TAP's Lupron is a member. TAP made a $2 million investment in Norwood Abbey's stock. Norwood will receive a milestone payment and royalty payments based on incremental sales in the immunology arena.

• Oxford BioMedica plc, of Oxford, UK, said its MoNuDin gene therapy product was effective in an animal model of motor neuron disease, resulting in significant motor improvement, a substantial delay in the onset of the disease and increased survival time. The product delivers a neuroprotective gene using the company's LentiVector delivery mechanism. The results were presented last week at the European Society on Human Gene Transfer and Therapy, held in Edinburgh, Scotland.

• Oxford Immunotec Ltd., of Oxford, UK, raised £2.5 million (US$4.2 million) from Quester Capital Management for the commercialization of a new diagnostic test for tuberculosis. The test, launched at the Medica Conference in Dusseldorf, Germany, is faster and more accurate than the existing skin test that has been in use for 100 years, Oxford said. The test measures white blood cells generated in response to TB infection, and can be used to monitor how their numbers vary over time, to determine if a person is infected, and if they are responding to treatment. The technology is based on research carried out at Oxford University.

• Predix Pharmaceuticals Inc., of Woburn, Mass., entered a partnership with RRD International LLC, of Ramat Gan, Israel, to bring Predix's first compound, PRX-00023, into the clinic. Predix expects to file an investigational new drug application to initiate a Phase I study for its serotonin 1A receptor agonist in early 2004. The collaboration should allow the initiation of clinical studies of Predix's anti-anxiety compound in the first half of next year. The proposed indications for PRX-00023 are for the treatment of general anxiety disorder and other neuropsychiatric conditions. PRX-00023 is a full agonist targeted against the GPCR 5-HT1A receptor.

• Prima Biomed Ltd., of Melbourne, Australia, reported new data from its preclinical drug development program for rheumatoid arthritis indicating that a short course of treatment with its compounds can result in sustained suppression of the debilitating autoimmune disease. The company said those findings validate past results in which scientists at Melbourne's Austin Research Institute identified the Fc receptor on human white blood cells as a key source of the chemicals that cause inflammation. .

• Progen Industries Ltd., of Brisbane, Australia, reported the divestiture of their non-core life sciences business unit with the agreement signed with Global Science and Technology Ltd., a subsidiary of New Zealand EBOS Ltd., of Christchurch, New Zealand. The transaction, valued at $1.2 million along with recent capital raising, leaves Progen with about $16 million in cash to focus on its cancer drug development.

• Switch Biotech AG, of Neuried, Germany, reported positive results from its clinical trials of its compound for treating psoriasis. The drug candidate, SWT01.100, had shown success in inhibiting T-cell activation and keratinocyte proliferation in previous trials, and the new results show modulation of ion channel activity in body cells. The product is in Phase II trials, with Phase III trials expected to begin in 2004.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said University of Maryland School of Medicine researchers published data in this month's issue of the Journal of Neurological Sciences showing that Copaxone (glatiramer acetate injection), used to treat relapsing-remitting multiple sclerosis, stimulates anti-inflammatory T cells to produce a neuroprotective protein, brain-derived neurotrophic factor (BDNF). More specifically, results demonstrated that in cell lines originating from the same patients, Copaxone-reactive T cells produced significantly higher levels of BDNF than T cells reactive to other compounds (p=0.033).

• The Genetics Co Inc., of Zurich, Switzerland, raised CHF14 million (US$10.5 million) in a Series B round of financing. The total amount includes CHF5.5 million from debt financing granted in connection with its recent acquisitions of core assets of CallistoGen AG, of Berlin, and Abeta GmbH, of Heidelberg, Germany, which has now been converted into equity. The round was led by Nextech Venture and Novartis Venture Fund. Other investors included Najeti Capital, Heidelberg Innovation and a number of individuals. The company plans to use the funds to progress its therapeutic lead projects in Alzheimer's disease and cancer.

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