• Amersham Biosciences, the life sciences business of Amersham plc, of London, signed an agreement with the Windber Research Institute in Windber, Pa., to develop a Scierra Solutions Laboratory Workflow System to manage the data generated in its clinical breast cancer project. Windber has been using Amersham's technology for gene expression, sequencing, genotyping and proteomics, but needed to expand its work to include a clinical laboratory workflow system to collect information on patient histories, samples and pathologies. Financial terms were not disclosed. In addition, Amersham signed a deal that expands the scope of its rights, under its existing license, to patents in the DNA microarray patent portfolio of Oxford Gene Technology, of Oxford, UK. The expanded rights give Amersham access to OGT's sequence variation patents as well as core patents relating to analyzing polynucleotide sequences. In addition, Amersham has obtained rights to sublicense the technology in the research and clinical diagnostics markets.

• Ark Therapeutics Ltd., of London, was granted a U.S. patent for EG009, its gene-based therapy for brain cancer. EG009 is injected following the removal of a tumor and prompts the production of thymidine kinase that subsequently converts a prodrug, ganciclovir, to a toxic form that kills dividing cells. Healthy neurons are nondividing, and thus unaffected. In the first clinical study, EG009 was well tolerated and produced an 80 percent increase in average survival time from eight to 15 months. A larger second study is nearing completion.

• Artus GmbH, of Delkenheim, Germany, together with Abbott Laboratories, of Abbott Park, Ill., released three tests for detecting infectious diseases, including the virus believed to cause severe acute respiratory syndrome. The SARS test is based on real-time polymerase chain reaction (PCR) technology and detects the virus in patient samples. Artus developed the test together with the Bernhard-Nocht Institute for Tropical Medicine in Hamburg, Germany. The other two PCR tests are for Chlamydia trachomatis and Mycobacterium tuberculosis. The tests will be available globally, except for the U.S., Canada and Japan. Artus will manufacture the test, while Abbott will be responsible for marketing and distribution.

• Berna Biotech Ltd., of Bern, Switzerland, granted Dynavax Technologies Corp., of Berkeley, Calif., worldwide, nonexclusive rights to a hepatitis B surface antigen, HBsAg. Dynavax will use the product in its programs for the disease to develop a prophylactic vaccine and therapeutic products that use its immunostimulatory sequence technology. Berna will supply HBsAg to Dynavax and will have the right to elect to commercialize resulting vaccine and therapeutic products on an exclusive basis. Financial terms were not disclosed.

• Biobase GmbH, of Wolfenbuttel, Germany, launched its Brenda enzyme database. It includes information on 80,000 enzymes, which have been largely extracted by hand from scientific publications, and the company already has customers in Europe, the U.S., Australia and Japan.

• BioGeneriX AG, of Mannheim, Germany, entered an exclusive agreement with Cangene Corp., of Winnipeg, Manitoba, in which it will market and distribute Cangene's recombinant human growth hormone in Europe. Both parties will jointly pursue European regulatory approval. Financial terms were not disclosed.

• Celltech Group plc, of Slough, UK, said a milestone was achieved in its deal with Amgen Inc., of Thousand Oaks, Calif., regarding the research, development and global commercialization of treatments for osteoporosis using Celltech's antibody fragment technology, which aims to identify antibody fragments against sclerostin, a protein discovered by Celltech. Amgen and Celltech scientists have identified a high-affinity, function-modifying Celltech antibody for further study, triggering an undisclosed payment to Celltech. In other news, Celltech Pharmaceuticals, a division of Celltech Group, licensed European sales and marketing rights for Xyrem (sodium oxybate) oral solution from Orphan Medical Inc., of Minneapolis. Orphan Medical received FDA approval in July 2002 to market Xyrem as a treatment for cataplexy in patients with narcolepsy. Celltech has indicated that it expects to file a Xyrem marketing authorization application for the cataplexy indication in Europe in early 2004 and would use its specialist sales forces to market the product to a target audience of neurologists and sleep specialists. Celltech will be responsible for the registration, sales and marketing of Xyrem in Europe. Celltech has made an up-front payment of $2.5 million to Orphan Medical and could make further payments of up to $6 million tied to product development milestones and up to $7 million tied to sales-related milestones. Celltech also will pay Orphan Medical a royalty on sales of the product, which will begin no earlier than 2005. The licensing agreement includes the use of Xyrem in narcolepsy and provides Celltech with rights to negotiate in regard to other potential future indications, including fibromyalgia syndrome.

• Chiron Corp., of Emeryville, Calif., announced the formal launch of Chiron Vaccines, to be headquartered in Oxford, UK, following the integration of PowderJect Pharmaceuticals plc, acquired by Chiron earlier this year. Sales for the combined entity were more than $600 million last year. The financial significance of the PowderJect acquisition was reflected in Chiron's third-quarter results, released last week, which showed revenues up by 47 percent to $540 million.

• Curacyte AG, of Munich, Germany, said its wholly owned subsidiary, Curacyte Chemistry GmbH, of Jena, Germany, was awarded a $1.2 million research and development grant from the German state of Thuringia's Corporate Technology Development program. The grant will fund the lead optimization and preclinical development of the company's orally available small-molecule inhibitors of the blood clotting factor Xa for the treatment of thrombotic disorders.

• Elan Corp. plc, of Dublin, Ireland, said the lead manager exercised its option to purchase an additional $60 million of guaranteed convertible notes due 2008 to cover overallotments in connection with the convertible notes offering announced Oct. 29, increasing the size of the issue to $460 million. Elan expects to settle the transaction Nov. 11. Late Thursday, Elan priced an offering of 35 million shares at $4.95 apiece and $400 million in notes, which were priced at par and will pay an annual coupon of 6.5 percent, payable semi-annually in arrears.

• Girindus AG, of Kuensebeck, Germany, said its U.S. subsidiary won a grant from the state of Ohio to accelerate the expansion of the oligonucleotide production at its facility in Cincinnati. The grant comes from a state fund to provide incentives for high-technology companies to locate in Ohio and will be disbursed over the next two years. Girindus manufactures active pharmaceutical ingredients.

• GPC Biotech AG, of Martinsried, Germany, reported the achievement of several milestones in its five-and-a-half-year alliance with Altana AG, of Bad Homburg, Germany, to build the U.S. Altana Research Institute (ARI) in Waltham, Mass. The milestones include the successful transfer of technologies, as well as research milestones reached under the drug discovery collaborations that are part of the ARI collaboration. The milestones trigger payments totaling $1.5 million to GPC Biotech.

• Hybrigenics SA, of Paris, entered an agreement with Group de Recherche Servier, also of Paris, to begin a pair of drug discovery collaborations and license arrangements related to cancer drugs. Servier will provide research funding for two years to Hybrigenics, as well as milestone payments and royalties on any resulting products. Servier will have exclusive worldwide rights to develop and market drugs against the selected targets, as well as an option for other therapeutic indications and a users' license to Hybrigenics' PIMRider software. More specific financial terms were not disclosed. The agreement marks the renewal of a drug target discovery collaboration that began in early 2001.

• Ingenium Pharmaceuticals AG, of Munich, Germany, and Molecular Engines Laboratories SA, of Paris, entered an agreement under which MEL gained exclusive rights to Ingenium's Ingenotypes TSAP6 genetic mouse model. TSAP6 is a gene discovered by MEL's scientific founders to have a role in cancer tumor reversion. Ingenium discovered the TSAP6 mouse model through its Deductive Genomics approach, which screens animals with random alterations in the genome. Terms of the agreement were not disclosed.

• Inpharmatica Ltd., of London, said UCB Research Inc., of Cambridge, Mass., became the first subscriber to its Biopendium Online proteomics database, launched in June. Biopendium Online contains 10 billion precalculated protein relationships derived from more than 1.4 million sequences from 150 different genomes.

• LION bioscience AG, of Heidelberg, Germany, and Silicon Genetics, of Redwood City, Calif., completed their first joint products, the LION Target Engine and SRS-GeneSpring Connectors. The companies entered a multiyear joint development and marketing collaboration in June with the goal of integrating their software technologies, and completed that first step ahead of schedule. The combination of the products is expected to enable researchers to improve the speed and accuracy of their analysis.

• Medical Marketing International Group plc, of Cambridge, UK, said it would be granted a European patent for its ruthenium chemotherapy compounds, being developed by its wholly owned subsidiary, Oncosense Ltd. In September, MMI claimed the preclinical ruthenium compounds have the potential to create a new class of cancer therapy, showing potency at least as great as carboplatin or cisplatin, but with lower toxicity and a novel mechanism of action.

• Merck KGaA, of Darmstadt, Germany, said its Australian pharmaceuticals subsidiary, Alphapharm Pty. Ltd., filed for marketing approval in that country for Erbitux (cetuximab) to treat metastatic colorectal cancer. Alphapharm, which is seeking approval of the drug as a monotherapy and in combination with irinotecan, could receive authorization by the end of next year. The drug is under FDA review following U.S. submission by ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York.

• MetaGen Pharmaceuticals GmbH, of Berlin, and Astex Technology Ltd., of Cambridge, UK, are merging. The merged company will operate as Astex Technology Ltd. The new company will continue work on Astex's fragment-based drug discovery and MetaGen's efforts in identifying and validating cancer targets will contribute to the effort. Financial terms were not disclosed.

• MWG Biotech AG, of Ebersberg, Germany, is cooperating with Quanta Biotech, of Somerton, UK, to develop new thermocycling technologies. Thermocyclers are analytical devices used in polymerase chain reactions for amplification or sequencing selected DNA sections. The companies report that the new cyclers will range from personal cycler, through multiblock, gradient, and into real-time PCR analysis. MWG expects to bring the first devices to the market in the first quarter.

• Optimata Ltd., of Tel Aviv, Israel, using predictive computer-based biosimulation, showed that significantly lower doses of a treatment when given at repeated intervals that respect natural biokinetics work better than a single, higher dose. The first test of its in silico model, known as the Virtual Patient Engine, provided a computer-generated validation of two new regimens of Genentech/Pharmacia and Amgen/Kirin recombinant human thrombopoietin (TPO), proven in mice and monkeys. TPO, designed to alleviate thrombocytopenia in patients during chemotherapy, had failed later-stage clinical trials because patients suffered from severe immunogenic side effects at the doses tested. The model predicted that significantly reduced doses when given at biologically respectful intervals would greatly reduce immunogenicity, improve efficacy, cease to cause side effects and increase platelet counts at levels forecast. The Optimata study will be published in the British Journal of Haematology on Nov. 17, 2003.

• Orchid BioSciences Inc., of Princeton, N.J., signed a definitive agreement to sell the assets of its diagnostics unit for $4.3 million to Tepnel Life Sciences plc, of Manchester, UK. Orchid Diagnostics provides systems, consumables and services for HLA testing for organ transplantation matching, tests for cystic fibrosis genetic screening and certain related support services. Tepnel, which will assume certain of the diagnostics business's liabilities, also will gain control of Orchid's facilities in Stamford, Conn., and Brussels, Belgium, and retain all current diagnostics employees.

• Pevion Biotech Ltd., of Bern, Switzerland, moved its lead candidate vaccine, a synthetic peptide in development for treatment of malaria, into a Phase I trial in 46 healthy volunteers. Pevion, a joint venture established in January 2002 by Berna Biotech AG, of Bern, and Bachem AG, of Bubendorf, is developing the vaccine in collaboration with the Swiss Tropical Institute in Basel. The vaccine, Pev3A, is based on Pevion's PeviPRO virosome platform, which comprises spherical lipid vesicles incorporating fusion proteins from the influenza virus.

• Pharmexa A/S, of Horsholm, Denmark, and Bavarian Nordic A/S, of Copenhagen, Denmark, entered a collaborative agreement that will test the use of Bavarian Nordic's MVA-BN vector technology in combination with Pharmexa's HER-2 DNA AutoVac vaccine. The parties expect that Phase I/II trials could begin in Germany and Italy within 18 months. In the spring of 2003, Pharmexa received approval from the UK and Denmark to continue into a Phase II trial with the HER-2 DNA AutoVac vaccine. In addition to testing HER-2 AutoVac MVA-BN directly in patients, the parties also expect to test another possibility in which HER-2 AutoVac MVA-BN will be combined in a way to stimulate the immune system.

• Phytopharm plc, of Godmanchester, UK, completed a Phase Ib study of its Alzheimer's and Parkinson's disease product, PYM50028, a neuroprotective agent derived from an Asian plant, and now is planning a placebo-controlled Phase II study in Alzheimer's patients. The results will trigger a milestone payment from Yamanouchi Pharmaceutical Co Ltd., of Tokyo, Japan, which licensed the product in a $33 million deal in May.

• Progen Industries Ltd., of Brisbane, Australia, said the terms of the placement agreement announced on Sept. 18 have been renegotiated. As a consequence of the Nasdaq Biotechnology Index falling by more than 10 percent since signing the agreement, the terms of the placement agreement signed with Taylor Collison Ltd. are no longer valid. Progen and Taylor Collison entered a new unconditional agreement in which 3.8 million shares were placed at $1.40 per share, raising a total of $5.3 million. The new funds will be applied to pursue a strategic growth strategy for the company that intends to build a pipeline of drug candidates. The company's PI-88 Phase II trial in multiple myeloma has been concluded with PI-88 meeting the trial efficacy endpoints, it said.

• Pyrosequencing AB, of Uppsala, Sweden, completed its purchase of Biotage LLC, the separations subsidiary of Dyax Corp., of Cambridge, Mass. Dyax received about $35 million for the unit. The sale was first reported earlier this month.

• Qiagen NV, of Venlo, the Netherlands, and Affymetrix Inc., of Santa Clara, Calif., entered a collaboration to optimize Qiagen's siRNA-mediated gene silencing technology using Affymetrix's GeneChip microarray technology. The collaboration aims to develop optimized procedures to be standardized to analyze gene-silencing effects on a genome-wide basis. Financial terms were not disclosed. Also, Affymetrix entered a nonexclusive agreement with PreAnalytiX GmbH, a joint venture between Qiagen and Becton, Dickinson and Co., of Franklin Lakes, N.J., to optimize the PreAnalytiX PAXgene Blood RNA System for use with the GeneChip technology to improve gene expression profile results on RNA extracted from whole blood.

• Serono SA, of Geneva, said the European Commission approved its new prefilled syringe for Ovitrelle (choriogonadotropin alfa). Designed to make infertility treatment easier for patients, the new Ovitrelle Solution for Injection is designed to enable patients to administer r-hCG in one step. Ovitrelle is used to promote follicle growth, ovulation and maturation of eggs in the ovaries.

• Teva Neuroscience Inc., a unit of Teva Pharmaceutical Industries Ltd., of Jerusalem, said 16-month retrospective data published in the November issue of the European Journal of Neurology showed that Copaxone (glatiramer acetate injection) was associated with a significant reduction in relapse rate and a high proportion of relapse-free patients compared to an untreated group. The Argentinean-based observational study evaluated 134 relapsing-remitting multiple sclerosis patients comparing Teva's drug or interferon treatment to a group of untreated patients. A significant fall in the annual relapse rate (compared with pretreatment values) was observed for all four treatments, including reductions of 81 percent in 30 Copaxone patients, 66 percent in 20 Rebif patients, 65 percent in 20 Betaseron patients, 49 percent in 26 Avonex patients and a 31 percent increase in 38 patients with no treatment.

The UK Health Protection Agency (HPA) Business Division, of Porton Down, UK, licensed exclusive rights to a meningitis B vaccine to Chiron Vaccines, of Oxford, UK. Financial terms were not disclosed but the deal includes an up-front payment, milestones and sales royalties. The HPA retains the right to continue R&D in the field. Currently, there are no vaccines for meningitis B.

• Transgene SA, of Strasbourg, France, entered an agreement with the French AIDS Research Agency (ANRS) and the French Institute for Health and Medical Research (INSERM) in which it will make constructs consisting of modified vaccinia ankara vectors carrying AIDS virus epitopes from Gag, Nef and Pol genes, and will manufacture the preclinical lots. INSERM, which owns the intellectual property of the Nef protein fragments, will conduct the immunological preclinical testing together with ANRS, which will make payments to Transgene.

• Watson Pharmaceuticals Inc., of Corona, Calif., acquired Amarin Development AB, a wholly owned drug development subsidiary of Amarin Corp. plc, of London, for about $15 million in cash. Watson said it expects the deal to have no financial impact on an earnings-per-share basis in 2003, including the amortization of goodwill. The buyout includes a number of patented, oral, controlled-release drug delivery technologies developed or under development by Amarin AB, as well as with the products it has developed using these technologies - including the recently approved glipizide extended-release tablets for hyperglycemia in Type II diabetes.

• Xcellsyz Ltd., of Newcastle-upon-Tyne, UK, secured a $125,892 DTI Grant for research and development. The grant will be used to help test the feasibility of Xcellsyz's human cell-based approach to drug discovery through further development of the company's lead compound series XD4000. The XD4000 family of compounds has been shown to act on three therapeutically relevant kinases: glycogen synthase kinase 3, rho-kinase II and p70s6 kinase.

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