• Amarin Corp. plc, of London, signed a definitive agreement to acquire privately held Laxdale Ltd., of Stirling, Scotland. The neuroscience development company's pipeline includes programs in Huntington's disease, treatment-unresponsive depression and other neurological disorders. Amarin licensed U.S. rights to Laxdale's Miraxion (formerly LAX-101) for Huntington's in November 2000. The purchase price includes an initial payment of 3.5 million Amarin American depository shares, worth about $3.3 million. Other success-related milestones could include a stock or cash payment of GBP7.5 million (US$14 million) on Miraxion's approval for Huntington's disease in the U.S. and Europe, for each approval, and a stock or cash payment of GBP5 million for each of the first two approvals for any other indication or product using Laxdale intellectual property. The transaction is contingent on Amarin shareholder approval, completion by Amarin of a $15 million financing and other customary conditions. Amarin agreed to loan Laxdale up to GBP950,000, a facility secured by a floating charge against Laxdale's assets.

• Avidis SA, of Clermont-Ferrand, France, raised €1.5 million from CHP, a private venture capital fund based in the same city, after completing an initial funding round in late 2002 in which it raised €1.7 million. Avidis uses a protein-engineering technology platform called Heptafold to develop vaccines and therapeutics. It also appointed François Miceli CEO; Fergal Hill executive director, research and intellectual property; and Michel Wurm executive director, business and preclinical development. Miceli joined Avidis from LMD Pharmacognosie, of Veyre-Monton, France.

• Benitec Ltd., of Queensland, Australia, and Promega Corp., of Madison, Wis., granted a worldwide nonexclusive research license to Merck & Co. Inc., of Whitehouse Station, N.J., to practice DNA-directed RNAi (ddRNAi) technology. The commercial research license provides Merck with freedom to use ddRNAi in undertaking research activities throughout its global operations, but does not provide downstream commercial rights for therapeutic development. Financial details were not disclosed.

• BioMérieux SA, of Lyon, France, now is listed on the Premier Marché of the Euronext stock exchange in Paris, following the initial public offering it launched in late June. The offering priced at €30 per share, toward the top end of the €26.90-€31.25 price range, and was five times oversubscribed. Some 30 percent of the company's equity now is in public hands.

• Bionomics Ltd., of Adelaide, Australia, entered a research collaboration focused on its animal model of epilepsy with the University of Wisconsin Medical School. The mouse model exhibits epileptic seizures similar to those found in humans. The research collaboration is funded by a five-year, $1.7 million grant from the National Institutes of Health. Bionomics will provide the university with the animal model, and gain access to new data and other intellectual property that result from the research.

• Biovitrum AB, of Stockholm, Sweden, and Artemis Pharmaceuticals GmbH, of Cologne, Germany, signed a research services agreement concerning the generation of RNAi-modified transgenic mice for the in vivo functional analysis of selected disease-related genes. Artemis will generate shRNAi knock-down transgenic mice that Biovitrum will use in certain pharmaceutical research programs. Biovitrum will provide selected shRNA sequences that correspond to genes that might play a central role in human diseases. Artemis will use its technologies to functionally down-regulate expression of targeted proteins.

• CJ Corp., of South Korea, received regulatory approval from the Korea Food and Drug Administration for Hextend, a product from licensing partner BioTime Inc., of Berkeley, Calif. Hextend is blood plasma volume expander. BioTime received a $300,000 license fee from CJ, which now will seek Korean National Health Insurance pricing. Following that six-month process, it could begin marketing Hextend. BioTime will receive a royalty on Hextend sales.

• Crucell NV, of Leiden, the Netherlands, and contract manufacturer DSM Biologics, of Groningen, the Netherlands, achieved the first development milestone in their protein-production collaboration. The alliance signed in December 2002 combines DSM's manufacturing capacity and production expertise with Crucell's PER.C6 cell line technology. The companies have secured 10 licensees to date and have been working on a development program that has demonstrated industry-high yields in Fed-batch and perfusion. DSM made an undisclosed milestone payment to Crucell. Separately, Crucell said GlaxoSmithKline plc, of London, renewed its PER.C6 technology license agreement. The pharmaceutical firm has a nonexclusive, worldwide license to use the technology for research and clinical development of viral-vectored biopharmaceutical products, with an option for a commercial license. Crucell will receive up-front and annual payments. Further financial details were not disclosed.

• Dompe International SA, of Lausanne, Switzerland, and AltaRex Medical Corp., of Edmonton, Alberta, signed an exclusive distribution agreement for AltaRex's lead product OvaRex MAb. The covered territory includes Italy, Spain, Portugal, Hungary, Poland, Czech Republic, Switzerland and Austria, as well as other Eastern European countries. The collaboration is structured so that AltaRex remains responsible for product development and registration of OvaRex upon commercialization for the agreed territory. Also, AltaRex will supply OvaRex to Dompe, and will work with Dompe and other collaborators in achieving OvaRex registration in Europe. The agreement, which grants Dompe certain rights of first refusal for additional cancer antibodies in the territory - such as BrevaRex, AR 54, ProstaRex and GivaRex - calls for Dompe to be responsible for product marketing, storage, sales and distribution in the territory.

• Elan Corp. plc, of Dublin, Ireland, completed the sale of its worldwide rights to Myobloc/Neurobloc (botulinum toxin Type B) injectable solution to the new company Solstice Neurosciences Inc. The sale includes related intellectual property, product inventory and the manufacturing facility. Employees will be offered the opportunity to continue work with Solstice. Financial terms were not disclosed. Myobloc was developed by Elan and is approved in the U.S., Canada and Europe for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain.

• Fujitsu Ltd., of Tokyo, and the National Institute of Genetics, also known as Idenken, agreed to collaborate on developing a next-generation database system. Idenken and Fujitsu plan to position it as the de facto standard for the field. The system will be based on Fujitsu's Interstage Shunsaku Data Manager Enterprise Edition XML database engine. The prototype is to be installed at Idenken's Center for Information Biology and DNA Data Bank in Japan, and is expected to be unveiled by the end of the year.

• Immuno-Designed Molecules SA, of Paris, said the European Commission granted its product Mepact orphan medicinal product designation for the treatment of osteosarcoma. Designation was granted following the positive opinion given by the European Medicines Agency and its Committee for Orphan Medicinal Products. Mepact obtained orphan drug status in the U.S. in June 2001. Mepact is an immune system stimulant designed to promote the destruction of cancer cells by activating macrophages present in the body.

The International Technology Cooperation Network in Germany and the Frankfurt Innovation Center for Biotechnology signed an agreement with the Indian state of Karnataka to facilitate establishing subsidiaries or joint ventures in the state, particularly in its capital, Bangalore. The Karnataka Biotechnology Development Council will work with German firms on policies and incentives to promote the sector. In May, MWG Biotech, of Ebersberg, Germany, opened a production and sales subsidiary in Bangalore.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland, said Phase II data of its chronic wound treatment product Allox demonstrated complete wound closure in 45 percent of patients, compared with 33.3 percent of controls. The study enrolled 110 eligible patients at 20 centers in Europe and America. Patients received Allox in different proportions and quantities of keratinocytes and fibroblasts. The primary endpoint was the closure of hard-to-heal ulcers after 16 weeks, while the secondary endpoint was ulcer size reduction. IsoTis and its subsidiary, EpiSource, intend to file an investigational new drug application to begin a Phase III trial of Allox.

• Jerini AG, of Berlin, said the FDA granted orphan drug status to Icatibant, the company's bradykinin receptor antagonist, for the treatment of edema in severe burn patients. Edema is a complication in burn patients with more than 20 percent of skin having second- and third-degree burns. Jerini plans to initiate Phase II trials for Icatibant in patients with severe burn injuries in 2005.

• Laboratories Del Dr. Esteve SA, of Barcelona, Spain, received import authorization for Ampligen, which is partnered with Hemispherx Biopharma Inc., of Philadelphia, to conduct a clinical trial in patients co-infected with hepatitis C and HIV viruses. Hemispherx shipped the total amount of vials of Ampligen required for the trial to Esteve, which agreed to conduct, at its expense, trials in that patient population as part of a 2002 agreement. In exchange, Esteve gained exclusive rights to market Ampligen in Spain, Portugal and Andorra for chronic fatigue syndrome.

• Merck KGaA, of Darmstadt, Germany, selected Chemical Diversity Labs Inc., of San Diego, as its preferred provider of screening libraries of lead-like small compounds through 2006. A steering committee with representatives from both companies will determine compounds to be synthesized by Chemical Diversity for early screening at Merck. Promising hits then will be further optimized and placed into Merck's discovery pipeline. Financial terms were not disclosed, though the agreement also includes an option to extend beyond 2006.

• Mologen AG, of Berlin, licensed its dSLIM-based product, DNABarrier II, to Starvax Inc., of Peking, China. The product is one of three applications in development based on Mologen's dSLIM immune-modulation technologies. The agreement between the companies provides for an up-front payment of €1 million. A first tranche of €400,000 already has been made. The license covers use of DNABarrier II in China and other East Asian countries, while Mologen will retain the rights for Europe, the U.S. and the rest of the world. Additional milestone payments and royalties also are part of the agreement.

• Morphochem AG, of Munich, Germany, appointed Sijmen de Vries CEO. De Vries was most recently head of global business development and licensing for Novartis Ophthalmics. He succeeds Lutz Weber, who had been both acting CEO and chief scientific officer for Morphochem, and who will continue as chief scientific officer. Morphochem specializes in thrombosis and infectious diseases.

• MWG Biotech AG, of Ebersberg, Germany, said it will engage in the worldwide distribution of the ExpressArt product line of mRNA amplification kits (excluding Great Britain, Japan and Switzerland), starting in September. Kits for the amplification of bacterial mRNA, for severely degraded RNAs from difficult samples, and from paraffin-embedded tissues will be launched before the end of 2004. The ExpressArt product line is based on a technology by Artus GmbH, of Hamburg, Germany.

• Novogen Ltd., of Sydney, Australia, began a second clinical trial to evaluate its cardiovascular drug, trans-NV-04. The company called the compound an advanced version of its experimental NV-04 compound. In the study, trans-NV-04 will be tested in subjects who are at risk of cardiovascular disease, but are otherwise healthy. Initially it will evaluate safety and tolerability in a dose-ranging study, followed by a randomized, crossover, placebo-controlled and double-blind study.

• Nycomed Group, of Roskilde, Denmark, provided notice that it is terminating a recently reported license agreement with San Diego-based Alliance Pharmaceutical Corp., its development partner for Oxygent in the European Union. Nycomed's decision was based on its interpretation of the scientific advice from the European Agency for the Evaluation of Medicinal Products with regard to Oxygent development for European approval. The EMEA advised that blood transfusion is considered an effective treatment of blood loss with a well-documented safety profile and said adverse events such as mismatching and infection are rare. Oxygent is a synthetic PFC emulsion-based oxygen therapeutic.

• Oxford BioMedica plc, of Oxford, UK, granted Viragen Inc., of Plantation, Fla., exclusive worldwide rights to a LentiVector gene delivery technology. The agreement allows Viragen to use the technology in its collaboration with the Roslin Institute in Edinburgh, Scotland, to develop Avian Transgenic Technology as a platform for manufacturing therapeutic proteins in chicken eggs. In exchange, Oxford received an up-front license fee and annual maintenance payments, and also is entitled to milestone payments and royalties. Further financial details were not disclosed.

• Paion GmbH, of Aachen, Germany, and Forest Laboratories Inc., of New York, entered an agreement for the U.S. and Canadian development and marketing of Paion's desmoteplase. The blood clot-dissolving agent is under development in the U.S. and Europe for acute ischemic stroke. Phase II results showed that the compound has the potential to treat patients up to nine hours after the onset of stroke symptoms. Forest made an undisclosed up-front payment to Paion, which also is entitled to milestone payments and royalties. Forest will fund all continuing clinical development activities for the U.S. and Canadian markets, where it is responsible for regulatory and sales and marketing activities. Forest also will have development and marketing rights to other indications in the territories. Paion retains commercial rights in Europe, Japan and the rest of the world.

• PamGene International BV, of s-Hertogenbosch, the Netherlands, licensed its 3-D Flow-Through Microarray Platform to Nottingham University in England. The license, which includes the sale of a PamGene 4-array PamStation, will enable the university to develop Multiplex Amplifiable Probe Hybridization (MAPH) as a service on the PamGene platform. MAPH is designed to determine copy number changes in genomic DNA.

• Probiodrug AG, of Halle, Germany, sold a platform of Dipeptidyl Peptidase IV (DP-IV) technology to Prosidion Ltd., of Oxford, UK, for $35 million, plus additional milestone payments if clinical candidate P93/01 is successfully developed. Prosidion is a subsidiary of OSI Pharmaceuticals Inc., of Melville, N.Y. The compound is about to enter Phase II testing for Type II diabetes. Prosidion will fund additional research at Probiodrug for three years.

• Recalcine Farmaceutica SA, of Santiago, Chile, and Aqua Bounty Technologies Inc., of Waltham, Mass., entered an agreement to develop, manufacture and market a range of aquatic veterinary vaccines, antimicrobial agents and diagnostic products targeted to infective species and strains specific to South America. The companies will create several regional diagnostic centers in shrimp and salmon farming areas to target shrimp and salmon diseases characteristic of the southern hemisphere.

• Schwarz Pharma AG, of Monheim, Germany, said findings from a multinational Phase IIb trial of rotigotine for restless legs syndrome produced a statistically significant and clinically relevant reduction of symptoms. The company, which licensed the dopamine agonist from Aderis Pharmaceuticals Inc., of Hopkinton, Mass., is preparing to begin Phase III testing next spring. Schwarz also plans to submit marketing approval applications for rotigotine for the treatment of Parkinson's disease this quarter.

• Sinovac Biotech Ltd., of Beijing, said the second subgroup of 14 volunteers in Phase I trials of its SARS vaccine received their first inoculation two weeks ago and blood tests have shown there are no adverse reactions to date. The first four volunteers also showed no adverse side effects. The vaccination and observation of 18 remaining volunteers soon will begin in different subgroups.

• SkyePharma plc and AstraZeneca plc, both of London, completed Phase III trials of a new version of AstraZeneca's Pulmicort (budesonide), an inhaled corticosteroid for asthma. The metered-dose aerosol inhaler (MDI) uses a hydrofluoroalkane propellant, replacing the chlorofluorocarbon propellant used in the marketed MDI version of Pulmicort. A milestone will be payable to SkyePharma upon delivery of final Phase III data and stability reports to AstraZeneca, expected in autumn. That is part of the total milestone payments of up to $12 million due to SkyePharma under the 2001 agreement. In addition, SkyePharma could receive royalties.

• Strand Genomics Pvt. Ltd., of Bangalore, India, and the CombiMatrix Group of Acacia Research Corp., of Newport Beach, Calif., entered a co-marketing agreement to market avadis, a data analysis software tool for microarray gene expression. Avadis combines scalable analytical algorithms with visualization to examine gene-expression data. It enables CombiMatrix's customers to order, redesign and reorder CustomArrays through various data analysis approaches within the avadis software.

• Swedish Brain Power, a neuroscience research program supported by six funding bodies in Sweden, has awarded €11 million to a team at Karolinska Institute in Stockholm, Sweden, led by Bengt Winblad. The funding will support research on earlier diagnosis of neurodegenerative diseases and the development of new therapies.

• T-cellic A/S, of H rsholm, Denmark, said its T-cell-guided cancer therapy is nearing clinical trials, following positive animal data indicating that it could use radiolabeled T cells to home in on tumors and metastases. The company aims to use tumor-specific T cells as carriers of cytotoxic cancer drugs.

• UCB Pharma, of Brussels, Belgium, said its recommended £1.5 billion (US$2.7 billion) cash offer for Celltech Group plc, of Slough, UK, for £5.50 per share was successful, with UCB acquiring or receiving acceptances equivalent to 92.8 percent of Celltech. The offer remains open for acceptances until further notice, but UCB now has the right to compulsorily purchase the remaining Celltech shares. UCB is listed in Brussels, and the company intends to cancel Celltech's listings on the London and New York Stock Exchanges.

• ViaLactia Biosciences Ltd., of Auckland, New Zealand, and Orion Genomics LLC, of St. Louis, said they would provide sequence data to characterize the gene sequence of ryegrass to Cold Spring Harbor Laboratory researchers in New York. The data stem from a 2001 research alliance. Cold Spring Harbor researchers will use the data to annotate publicly available plant sequences with the aim of improving forage and cereal crops for greater nutritive value and higher yield. Results will be made available through the Gramene database.

• Xenova Group plc, of Slough, UK, began patient dosing in a Phase III trial of TransMID to treat progressive or recurrent non-operable glioblastoma multiforme. The randomized, open-label, multicenter trial will enroll up to 323 patients who have failed conventional therapy. It will compare TransMID against a number of chemotherapeutic agents. In May, Xenova and the FDA reached agreement under the special protocol assessment procedure for the revised Phase III trial program.

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