• ACE Biosciences A/S, of Odense, Denmark, named Ingelise Saunders CEO. Saunders was CEO of the Celltech Pharmaceuticals subsidiary of Celltech Group plc, until its acquisition by UCB SA, of Brussels, Belgium, in May. She previously spent 15 years at Novo Nordisk A/S, of Bagsvaerd, Denmark.

• ACO HUD, of Stockholm, Sweden, and Avanir Pharmaceuticals Inc., of San Diego, signed an exclusive agreement to manufacture and market Avanir's docosanol 10 percent cream as a treatment for cold sores in Sweden, Norway, Denmark and Finland. ACO HUD will be responsible for all sales and marketing activities, as well as manufacturing and distribution. It plans to launch Avanir's product in 2005. Avanir will receive a license fee, royalties and milestones related to product approval.

• Amarin Corp. plc, of London, raised gross proceeds of $12.75 million after completing a private placement of about 13.4 million ordinary shares at about 95 cents apiece to a group of new and existing accredited investors and management. Amarin said the financing allows it to drive forward with plans for Phase III trials of Miraxion, its lead compound for Huntington's disease, and would facilitate in-licensing discussions for new late-stage compounds and out-licensing discussions with prospective partners for indications outside neurology.

• Antisense Therapeutics Ltd., of Melbourne, Australia, accepted a proposal from the Bank of New York to establish a Level 1 American depository receipt program. The company, which expects the stock listing to provide exposure to its programs, is developing antisense pharmaceuticals. Its two most advanced projects target multiple sclerosis and psoriasis.

• Arexis AB, of Gothenburg, Sweden, entered a commercial agreement with Beiersdorf AG, of Hamburg, Germany, under which the latter will develop skincare products based on Arexis' research on skin enzyme biology and biochemistry. The companies plan to develop products that specifically target the activity of enzymes involved in controlling cell turnover within the outer layer of the skin epidermis. Beiersdorf will be responsible for skin assay development, topical formulation and clinical testing. Financial terms were not disclosed.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, signed service and license agreements in the area of mouse genetics and genomics. Boehringer Ingelheim granted Artemis a worldwide exclusive commercial license and a nonexclusive research license, including sublicensing rights, to the patented tetraploid technology for the generation of genetically modified mice. The technology facilitates the generation of modified mice directly from mouse embryonic stem cells.

• Australian Cancer Technology Ltd., of Sydney, Australia, said it received A$1.9 million (US$1.4 million) through a share placement with Bioaccelerate Inc., of New York. Terms call for the sale of about 4.9 million AustCancer shares at about A38 cents apiece. Included in the agreement is a commitment to a wider collaboration, focused in particular on a new prostate cancer compound introduced by Bioaccelerate. The collaboration also will include work on AustCancer's pancreatic drug, RP101, which is targeted at preventing cells from developing resistance to chemotherapy.

• Benitec Ltd., of Queensland, Australia, granted a nonexclusive license to Revivicor Inc., of Blacksburg, Va., to use Benitec's ddRNAi technology in the field of regenerative medicine to replace human cells, tissues and organs. The ddRNAi will be used to down-regulate genes in transgenic pigs, supplying tissues and organs for grafting and transplantation in humans, called xenotransplantation. Revivicor already has begun preclinical trials. In exchange, Benitec will receive up-front and annual maintenance fees, a milestone payment upon FDA approval and ongoing royalty payments upon commercialization. Further financial terms were not disclosed.

• Biofrontera AG, of Leverkusen, Germany, acquired a Phase II compound for various cancerous and precancerous skin lesions, and some gynecological indications, from ASAT AG, of Zug, Switzerland. The product applies aminolevulinic acid in a nanocolloid formulation, which is suited for photodynamic therapy. Biofrontera said it provides effective permeation, specifically into malignant tissue, and enhances the formation of protoporphyrine in those cells, ultimately causing cell degeneration. Its efficacy and safety have been investigated, with positive results in pilot Phase II and III studies. Financial terms were not disclosed.

• BioInvent International AB, of Lund, Sweden, said the American Heart Association's journal, Circulation, presented in its latest issue a report on antibody-based treatment of atherosclerosis. The report describes research performed by a team led by professor Jan Nilsson at the University Hospital MAS in Malmo, Sweden, in collaboration with BioInvent. The antibody-based drug candidates have been shown to reduce plaque formation in preclinical animal studies, the company said.

• bioMerieux, of Paris, its affiliates and Gen-Probe Inc., of San Diego, signed licensing agreements granting access to Gen-Probe's ribosomal RNA technologies and, in turn, providing Gen-Probe admittance to bioMerieux's intellectual property related to genetic mutation detection, specifically in blood clotting disorders. Terms include a payment to Gen-Probe of up to $250,000 for a limited nonexclusive research license and options to develop diagnostic products for certain targets using its technology. Options if exercised could be worth an aggregate $4.5 million. BioMerieux also could acquire development rights for extra targets, paying up to $3 million by the end of 2006, and Gen-Probe is entitled to sales-based royalties. Gen-Probe will pay bioMerieux $1 million plus potential royalties for a nonexclusive worldwide license to its intellectual property to develop mutation detection kits focusing on genes coding for Factor V and prothrombin. The French company ended agreements to develop assays for its VIDAS instrument with Gen-Probe, which expects to record the remaining $500,000 in the third quarter. The companies agreed that Gen-Probe could negotiate rights to develop certain transcription-mediated amplification assays to run on bioMerieux's Easy Q platform.

• BioVision, of Hannover, Germany, said improvements on its Peptidomics technologies were presented at the Protein Biomarkers Conference in Philadelphia. Peptidomics comprises methods and technologies for analyzing small proteins and peptides in clinical research and development and for accompanying studies. The company increased the sensitivity of analysis methods and accelerated research projects by integrating a new generation of mass spectrometers, improving internal process chains and providing sample preparation.

• Cellectricon AB, of Gothenburg, Sweden, named Ulf Jonsson CEO effective Jan. 1. He has served as CEO of Biacore and worked for London-based Amersham Pharmacia Biotech (now Amersham plc) as marketing manager for molecular biological systems.

• Crucell NV, of Leiden, the Netherlands, began patent-infringement proceedings in the District Court of Dusseldorf against Cevec Pharmaceuticals GmbH. Crucell alleges that Cevec is planning to create a company based on a human cell line that mirrors features of Crucell's patented PER.C6 technology. Crucell said on Oct. 6 the European Patent Office granted a patent covering cell lines marketed by Crucell as part of its PER.C6 technology.

• Debiopharm SA, of Lausanne, Switzerland, said researchers presented data at the 11th international symposium on hepatitis C and related viruses held in Heidelberg, Germany, on the inhibition effect of DEBIO-025 on the replication of the hepatitis C virus. Using the luciferase activity in Huh-5-2 cells, the compounds were about 10-fold more potent than cyclosporine A. Debiopharm started Phase I studies this year with DEBIO-025, which demonstrated a favorable toxicological profile and was well tolerated in healthy volunteers.

• DeCode Genetics Inc., of Reykjavik, Iceland, was awarded a five-year, $23.9 million contract by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md. Under the contract, DeCode will apply its population approach and resources to discover genetic factors associated with susceptibility to certain infectious diseases and with vaccine response. DeCode will work with scientists at the University of New Mexico to conduct functional validation of biological pathways discovered through its genetics research. The National Center for Genome Resources will provide bioinformatics resources to make study information and results available to the scientific community.

• Epigenomics AG, of Berlin, began a research collaboration with Biogen Idec Inc., of Cambridge, Mass., to identify potential biomarkers for use in an oncology program. Epigenomics will use its DNA methylation technology to examine candidate biomarkers. Epigenomics will receive research and development funding and said it has an opportunity to participate in the development of a potential pharmacodiagnostic product. Financial terms were not disclosed.

• Evotec OAI AG, of Hamburg, Germany, signed an agreement with Altana Pharma AG, a division of Altana AG, of Konstanz, Germany, to advance the discovery of one of their kinase targets. The companies will seek to identify and optimize lead compounds that interact with the target by applying Evotec's drug discovery engine. Financial terms were not disclosed.

• Ferring Pharmaceuticals A/S, of Copenhagen, Denmark, said degarelix, its new gonadotrophin-releasing hormone blocker (GnRH), showed rapid onset and sustained activity in a Phase II study in men with prostate cancer. Degarelix is designed to target and block the GnRH receptor. At the highest dose, 97.5 percent of patients experienced a reduction in testosterone to target levels of less than 0.5 ng/ml within three days of treatment.

• GeneMedix plc, of Newmarket, UK, raised £830,000 (US$1.5 million) through a placing of 7.5 million new shares. The shares, representing 2.4 percent of the biogenerics company's equity, were placed with new and existing investors.

• Genetic Technologies Ltd., of Melbourne, Australia, granted a licensed to Genzyme Corp., of Cambridge, Mass., for human-testing applications, as part of a new collaboration. Genzyme will pay GTL a signing fee and an annual fee for the life of certain non-coding patents. The rights apply nonexclusively in the U.S., Europe and Japan. GTL retains all rights in the Asia-Pacific region. Financial terms were not disclosed.

• GNI Ltd., of Tokyo, entered a research and development collaboration with Toyama Chemical Co. Ltd., of Tokyo, for use of its gene regulatory network technology platform in Toyama's drug development efforts. GNI will also offer its gene-expression data and discovery services.

• Hapto Biotech Inc., of Jerusalem, and Ortec International Inc., of New York, formed a joint venture partnership for the purpose of further developing product leads identified through a research collaboration established in September 2002. The partnership will seek to optimize the combination of peptides found in Hapto's Haptide technology with the properties of Ortec's collagen biomaterial.

• Helsinn Healthcare SA, of Lugano, Switzerland, granted exclusive Israeli rights to palonosetron (Aloxi) to Rafa Ltd., of Jerusalem. The 5-HT3 receptor antagonist was approved by the FDA to prevent acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. U.S. rights belong to MGI Pharma Inc., of Minneapolis.

• Karo Bio AB, of Huddinge, Sweden, carried out a new share issue with preferential rights for the company's shareholders generating about SEK96 million (US$13.1 million), excluding transaction costs. The subscription period ended Oct. 1. The rights issue was expected to be 98.9 percent subscribed with preferential right for the shareholders. Remaining shares will be allocated by the company's board.

The Medicon Valley Academy (MVA) and the UK government established a collaboration, the MVA-UK Challenge Programme, to foster cooperation in biotechnology research between the UK and the Medicon Valley region, which spans the greater Copenhagen area and the Sk ne region of southwest Sweden. Lord Sainsbury, the UK trade and industry minister, unveiled the initiative at the BioTech Forum in Copenhagen last week.

• Mologen AG, of Berlin, started a collaboration with the Max Planck Institute for Infectious Biology to develop a DNA-based prophylactic tuberculosis vaccine. The collaboration will make use of Mologen's "minimalistic immunogenically defined gene expression" (MIDGE) technology. The partners expect the collaboration to last about 18 months. Financial details of the deal were not disclosed.

• MorphoSys AG, of Martinsried, Germany, reported initial in vitro and in vivo data on its internal cancer antibody program, MOR202, at the Human Antibodies & Hybridomas conference in Dublin, Ireland. By directing the antibodies against primary patient tumor material and specific hematologic cancer cell lines, the assays demonstrated that the antibodies were able to kill cancer cells efficiently. A MOR202 antibody also proved to be effective in an in vivo animal model. The fully human antibodies are directed against CD38, and the MOR202 program is in preclinical development for multiple myeloma and other blood cancer-related diseases. MorphoSys plans to out-license the MOR202 antibody program before starting clinical development.

• Newron Pharmaceuticals SpA, of Bresso, Italy, licensed a series of ion channel modulators to Dynogen Pharmaceuticals Inc., of Boston, which will apply its predictive pharmacology platform to assess their potential as treatments for genitourinary and gastrointestinal disorders. Financial terms were not disclosed.

• Paion GmbH, of Aachen, Germany, licensed the rights to develop and market the neuroprotective drug Enecadin from Nippon Shinyaku. Paion's license covers global rights, except for Japan, where the companies will have coexclusive rights. Paion has made an up-front payment of undisclosed size, and could make milestone and royalty payments. The company expects to begin Phase II trials for the compound next year.

• Peplin Biotech Ltd., of Brisbane, Australia, and Allergan Inc., of Irvine, Calif., agreed to discontinue their collaboration for the development and commercialization of skin cancer products in North and South America based on Peplin's cancer compound PEP005. Allergan said it continues to believe that Peplin's lead investigational product PEP005 Topical has potential in the market for treating non-melanoma skin cancer. Terms of the deal's dissolution were not disclosed.

• PharmaMar SA, of Madrid, Spain, received orphan drug status for Aplidin, its second marine-derived compound, now in Phase II development. Aplidin has twice been granted orphan designation - the first time in June for acute lymphoblastic leukemia. The antitumor agent derived from the marine tunicate Aplidium albicans is designed to induce apoptosis and inhibit secretion of VEGF. Separately, PharmaMar said the FDA designated Yondelis an orphan drug for soft-tissue sarcoma. The U.S. application was sponsored by Johnson & Johnson Pharmaceutical Research & Development Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. European authorities already granted orphan status to the product, a marine-derived antitumor agent isolated from the colonial tunicate Ecteinascidia turbinata.

• Pharmaplaz, of Athlone, Ireland, and Samaritan Pharmaceuticals Inc., of Las Vegas, entered a collaboration for the production and supply of Samaritan's lead compound, SP-01A, and its product pipeline that includes AIDS, Alzheimer's disease, cancer and cardiovascular disease products. The companies will work on pipeline development, scale-up and manufacturing requirements, while Pharmaplaz also will work on drug formulation and testing, production of pilot batches, development of analytical methods, drug specifications, process validations and drug optimization.

• Phynova Group plc, of Oxford, UK, launched a fund raising for up to £3 million (US$5.4 million) to fund development of treatments for infectious diseases and cancer that are based on Chinese herbal medicines. Phynova has a joint venture with the Chinese Ministry of Health. Phynova's lead product, PYN 17, for the treatment of hepatitis C, is in a Phase II trial in the UK, with results expected next year. Other compounds in development are PYN5 for respiratory tract infections, which has shown activity against the severe acute respiratory syndrome coronavirus in vitro; PYN6 for treating antibiotic-resistant infections; and PYN7 for treating cancer of the esophagus.

• pSivida Ltd., of Sydney, Australia, and Singapore General Hospital announced interim data from a Phase IIa trial of Brachysil in the treatment of inoperable liver tumors. The first four patients, reviewed three months after treatment, had an average of 60 percent regression of the treated tumors. Brachysil, developed by Qinetic Group plc, pSivida's largest shareholder, is a nanostructured form of silicon loaded with the radioactive isotope 32P. The product is injected directly into solid tumors. PSivida is developing Brachysil as a medical device.

• Sareum Holdings plc, of Cambridge, UK, raised £2 million (US$3.6 million) in a placing of 100 million shares at 2 pence per share, and joined the Alternative Investment Market in London. Sareum was founded by executives made redundant last year when Millennium Pharmaceuticals Inc., of Cambridge, Mass., shut its research center in the UK. Following the AIM listing, the company has a market capitalization of £6.96 million.

• Serono International SA, of Geneva, said data reported at the European Committee for Treatment and Research In Multiple Sclerosis meeting in Vienna, Austria, showed that relapsing-remitting multiple sclerosis patients who were on placebo and then treated with Rebif in the PRISMS study showed substantial clinical benefits, with a 54 percent relative reduction in relapse rate. There was a statistically significant relative reduction in the mean number of brain lesions of 67 percent, and in addition, 76 percent of patients treated with Rebif 44 mcg remained free of disease progression. The findings are based on a prospective pre-planned analysis of the progress of patients who received two years of placebo therapy followed by two years of Rebif in PRISMS.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said data presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis held in Vienna, Austria, demonstrated the clinical benefits of Copaxone in relapsing-remitting multiple sclerosis. Results with Copaxone were superior to treatment with interferon-beta therapies on several clinical endpoints, and to no treatment in terms of preventing relapses and slowing disability progression. The company's subsidiary, Teva Neuroscience Inc., also said that MS patients who remained on Copaxone therapy for an average of 10 years showed significantly less progression of disability compared to patients who discontinued therapy. Teva Neuroscience plans to extend the observation period of the trial to 15 years.

The U.S. Department of Health and Human Services granted four new contracts totaling more than $232 million to fund development of vaccines against three potential agents of bioterrorism: smallpox, plague and tularemia. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., will administer the contracts. Two contracts are worth up to $177 million for MVA vaccines against smallpox. The three-year contracts were awarded to Bavarian Nordic A/S, of Copenhagen, Denmark, and Acambis plc, of Cambridge, UK. Avecia Biotechnology Ltd., of Manchester, UK, received a three-year, $50.7 million contract for the manufacture of a new plague vaccine as well as animal testing and initial human trials.

• Varian Inc., of Palo Alto, Calif., entered a definitive agreement to acquire Magnex Scientific Ltd., of Oxford, UK, for $32 million in cash and assumed net debt. The transaction also includes an opportunity for additional purchase price payments over three years, depending on financial performance. Magnex designs and manufactures magnetic resonance imaging magnets, and it is a supplier of vertical high-resolution nuclear magnetic resonance magnets, superconducting magnets for Fourier Transform mass spectroscopy, and MR microscopy gradients. Varian expects the acquisition to generate external revenues of $15 million to $18 million in the first 12 months. Magnex will operate as a wholly owned subsidiary of Varian. Closing is expected in 30 days.

• Wilex AG, of Munich, Germany, entered an agreement with Centocor Inc., of Malvern, Pa., that gives Wilex the option to acquire exclusive U.S. marketing rights on the antibody Rencarex (WX-G250). Under the deal, Centocor received an option fee and is eligible for milestone payments and royalties. Wilex now has an option to own full worldwide marketing rights on its lead compound, Rencarex, excluding certain countries of southern Europe where it already has a marketing partnership with Esteve SA, of Barcelona, Spain. In August 1999, Wilex acquired an exclusive license to Rencarex from Centocor for all countries outside of the U.S., and in the process assumed full clinical development and financial responsibility for the compound. Wilex is conducting a global pivotal Phase III trial with adjuvant Rencarex in non-metastasized renal-cell carcinoma.

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