• Amarin Corp. plc, of London, signed an agreement with Valeant Pharmaceuticals International Inc., of Costa Mesa, Calif., on a dispute related to the sale of Amarin Pharmaceuticals Inc. (API). Amarin sold API and a majority of its U.S. products to Valeant. Under the agreement with a mutual release of claims, the companies agreed to waive $6 million of the $8 million in contingent milestones due Amarin. The remaining $2 million is no longer contingent and is payable by Valeant on Nov. 30. Valeant waived Amarin's contingent obligation to repurchase $414,000 of wholesale inventory. The agreement is subject to approval from Elan Corp. plc, of Dublin, Ireland, on or before Oct. 7. Of the $2 million, half is payable to Elan as part of a settlement between Elan and Amarin. Separately, Amarin's nonexecutive chairman, Thomas Lynch, agreed to buy the following securities in Amarin from Elan and its subsidiaries: about 4 million American depository shares representing about a 26 percent shareholding on an undiluted basis; warrants to subscribe for 500,000 Amarin ordinary shares at an exercise price of $1.90 per share; and $5 million in principal amount of Amarin secured 8 percent loan note, issued pursuant to a loan note instrument dated Feb. 25.

• Biacore International AB, of Neuch tel, Switzerland, is cutting its R&D work force from 95 to 65 employees following a business review. The move, combined with a reduction in the use of external consultants, will yield cost savings of SEK55 million (US$7.5 million). The company also has written off SEK44 million in the asset value of its array technology, following a decision to revise its launch strategy and reduce its medium-term sales forecast. The company also will shut down its headquarters in Neuch tel and relocate to Uppsala, Sweden, by mid-2005. The company plans to cut a total of about 80 positions from its present work force of 345 people. It will take a one-off charge of SEK80 million, which includes the array technology write-down, in the fourth quarter. It said the actions will lead to annualized savings of SEK90 million.

• BioAlliance Pharma SA, of Paris, reported preclinical data demonstrating that styrylquinolines, a new family of inhibitors the company is developing, specifically and efficiently inhibit the nuclear import of integrase, thereby blocking the viral replication of HIV-1-infected cells. The company said the findings are significant because they point to a way of combating the emergence of drug-resistant strains of HIV-1.

• BioInvent International AB, of Lund, Sweden, entered a long-term collaborative research and licensing agreement with ThromboGenics Ltd., of Dublin, Ireland, to co-develop antibody-based drugs for vascular indications. Both parties will provide core intellectual property based on specific therapeutic targets and will share costs and revenues equally, though when a candidate has been identified prior to the collaboration, the revenue split will be 60/40. The initial program will focus on the co-development of ThromboGenics' fully human anti-Factor VIII monoclonal antibody as an anticoagulant therapy for indications such as the prevention and treatment of deep-vein thrombosis and treatment of atrial fibrillation.

• Cosmo Bio Co. Ltd., of Tokyo, launched its new U.S. subsidiary, Cosmo Bio USA, in West Carlsbad, Calif. Cosmo Bio USA will offer more than 2,000 products and services, including its Bioruptor multi-sample cell disruptor, I-MyRun HTS agarose gel electrophoresis system and a range of Japanese-made antibodies and reagents.

The European Centre for Disease Prevention and Control held its official start-up meeting in Stockholm, Sweden. David Byrne, EU health commissioner, said the center will provide more effective surveillance of infectious diseases, improve preparation for and response to epidemics and lead to better disease prevention. The center, which is due to start operating in May 2005, will not replace national bodies but provide them with a central reporting and coordinating point.

• Evolutec Group plc of Oxford, UK, said its partner Merial Animal Health Ltd., of Harlow, began the treatment phase of cattle trials with Evolutec's vaccine against ticks and tick-borne disease. Results are due toward the end of 2005, and if positive will trigger a milestone payment to Evolutec, which went public on London's Alternative Investment Market in June.

• Genmab A/S, of Copenhagen, Denmark, got positive safety data in a HuMax-EGFr Phase I/II study in head and neck cancer. No patients experienced dose-limiting toxicity receiving doses up to 8 mg/kg, and preliminary pharmacokinetic data suggest that saturation of the EGF receptor is provided by doses close to 2 mg/kg. Genmab expanded the ongoing study to include a group of up to 10 additional patients at the highest dose level.

• GenOway, of Lyon, France, entered a research agreement with Pfizer Inc., of New York, to provide Pfizer researchers in the U.S. with a genetically modified rat model based on GenOway's nuclear transfer program. It is GenOway's second agreement with the biopharmaceutical sector to generate conditional knockout and knock-in rat models.

• GPC Biotech AG, of Martinsried, Germany, said that data on its cancer monoclonal antibody, 1D09C3, were presented at the 16th annual EORTC-NCI-AACR meeting in Geneva. The data demonstrate that 1D09C3 selectively induced apoptosis in a variety of xenotransplant lymphoid tumor models. It is an anti-MHC (major histocompatibility complex) Class II monoclonal antibody that binds to certain cell-surface receptors, selectively killing activated, proliferating MHC Class II-positive tumor cells.

• Henderson Morley plc, of Birmingham, UK, released interim results from a Phase II named-patient study of its Ionic Contra Viral Therapy (ICVT) in the treatment of warts caused by herpes papillomavirus. ICVT is designed to prevent viruses replicating by changing the electrical characteristics of the host cell. The company said the latest data show its gel formulation of ICVT is able to penetrate through the skin to the dermis. No adverse effects were detected, and the warts were treated successfully.

The Institut Pasteur, of Paris, and Procter & Gamble Pharmaceuticals, of Cincinnati, signed an agreement providing for P&GP to develop and commercialize EFD, a new immunomodulating drug, for the treatment of asthma and other allergies. The drug was discovered in a joint research program carried out by the Institut Pasteur and P&GP, a subsidiary of the Procter & Gamble Co. The agreement grants P&GP an exclusive worldwide license for the development, manufacture and commercialization of EFD. Financial terms were not disclosed. P&GP will start a preclinical evaluation of the compound, which inhibits allergy-related bronchial hyper-reactivity by regulating the immune response. In animal models, a single administration was found to inhibit the liberation of cytokines and cells associated with the allergy for more than a month.

• KaroBio AB, of Huddinge, Sweden, said its preferential rights issue was fully subscribed and generated SEK96 million (US$13.1 million) net of expenses. The company said its board will decide whether it will authorize the issue of an additional tranche of new shares that would represent up to 10 percent of the total number of shares outstanding at present. That would yield additional gross proceeds of SEK24 million.

• Nitec Pharma AG, of Basel, Switzerland, raised $10 million in a Series A funding led by Atlas Venture and Global Life Science Ventures. Nitec was recently spun out of Merck KGaA, of Darmstadt, Germany. The company will focus on anti-inflammatory drugs. It has a compound in Phase III trials, and will use the funding largely to advance the trials.

• Nucleonics Inc., of Horsham, Pa., requested that the U.S. Patent and Trademark Office re-examine a patent belonging to Benitec Ltd., of Queensland, Australia, and the Australian Commonwealth Scientific and Industrial Research Organization. U.S. Patent No. 6,573,099 is titled "Genetic Constructs for Delaying or Repressing the Expression of a Target Gene." The request submits prior art documents showing the patent claims are invalid because they lack novelty or they were obvious at the time the priority patent application was filed. Nucleonics also believes that the claims are ambiguous. Nucleonics made a similar filing in September with the Commissioner of Patents in Australia.

• PharmaMar SA, of Madrid, Spain, presented data from six studies, four of which were from pharmacogenomics research projects at the EORTC-NCI-AACR conference in Geneva. The results presented at the conference reported on two studies of Yondelis, one of Aplidin and one of Kahalalide F.

• Pierre Fabre Dermotologie, of Castres, France, signed an agreement with Connetics Corp., of Palo Alto, Calif., for exclusive commercial rights to Connetics' Olux (clobetasol propionate) Foam, 0.05 percent for Europe, excluding Italy where the product is licensed to Mipharm SpA, of Milan. The agreement with Pierre Fabre also grants marketing rights for certain countries in South America and Africa. The product will be marketed by Pierre Fabre under different trade names. Connetics will receive an up-front license payment, potential milestone payments and royalties. Pierre Fabre will be responsible for costs associated with product manufacturing, sales, marketing and distribution in its licensed territories.

• ProBioGen AG, of Berlin, entered an agreement with Chiron Vaccines, a unit of Emeryville, Calif.-based Chiron Corp. to evaluate ProBioGen's vaccine cell lines for vaccine production. ProBioGen will create cell lines derived from primary tissue under pre-specified criteria. Chiron Vaccines will test the lines' capabilities in virus propagation and productivity against currently used vaccine cell substrates. Both companies have option rights to enter into collaboration to further develop cell lines for vaccine applications.

• SC Biosciences, of Tokyo, and Cyntellect Inc., of San Diego, formed a marketing agreement in which SC will exclusively market Cell Xpress cell line development service in Japan. The service is based on Cyntellect's high-throughput LEAP platform, and offers accelerated cloning of cell lines possessing ideal growth and protein-secretion properties, Cyntellect said.

• Schering AG, of Berlin, and Tripos Inc., of St. Louis, expanded their contract that governs the companies' ongoing discovery informatics collaboration on the Enterprise Chemical Information Management System, which is designed to allow Schering scientists to manage their chemical research plans more efficiently.

• Sirenade Pharmaceuticals AG, of Martinsried, Germany, appointed Lynn Butler CEO. Pierfausto Seneci, who had been interim CEO, has been named chief scientific officer. Butler joins Sirenade from Swentibold sprl, of Ghent, Belgium, where she was director. Sirenade, formed in the merger of Nadag AG and Sireen AG in 2003, is specialized in neurodegenerative diseases and pain.

• SkyePharma plc, of London, said it reached accord with Merck KGaA, of Darmstadt, Germany, to assign the companies' agreement signed in August 1998 to a new Swiss company founded by former Merck executives. The agreement surrounded the development of a formulation of an unnamed drug using SkyePharma's Geomatrix oral delivery technology. The Swiss company will assume all funding obligations from Merck for development including the Phase III under way in Europe. It also will seek marketing partners outside Europe. SkyePharma is entitled to sales-dependent royalties and will manufacture product at its Lyon, France, plant. Merck retains marketing rights in Germany and Austria.

The Swiss government launched a referendum campaign in support of a law permitting embryonic stem cell research that would use fertilized eggs left over from in vitro fertilization procedures. The legislation already has been passed by the country's parliament but organizations opposed to the initiative, which include anti-abortion groups and the Swiss Green party, collected sufficient signatures to trigger a referendum. The vote will take place Nov. 28.

• Teva Neuroscience Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem, said Agilect (rasagiline mesylate) taken once daily significantly improved symptoms of Parkinson's disease both as initial monotherapy in patients with early Parkinson's disease and as adjunct treatment to levodopa in moderate to advanced patients. The data were presented at the American Neurological Association annual meeting in Toronto. Teva Neuroscience and Eisai Inc., of Teaneck, N.J., will co-promote Agilect in the U.S. The studies were conducted in the U.S. and Canada and included more than 875 patients.

The UK National Centre for the Replacement, Refinement and Reduction of Animals in Research announced funding for projects totaling £860,000 (US$1.5 million) following the inaugural meeting of the center, which was set up earlier this year by the government to minimize the use of animals in research. The first two grants, worth £360,000 in total, were awarded to a group researching methods for detecting behavioral changes in mouse knockouts that indicate poor welfare, and to a second group working on ways to avoid and alleviate cancer pain in rodents.

• Trinity Biotech plc, of Dublin, Ireland, received FDA approval for the use of its Uni-Gold Recombigen HIV test with finger-stick whole-blood samples. The test gives results within 10 minutes and is approved for the detection of antibodies to HIV in human serum, plasma, venous and finger-stick whole blood. The company has sold about $6 million of the products in the first three quarters of 2004.

• Vernalis plc, of Reading, UK, licensed exclusive worldwide rights to an Hsp90 inhibitor program from Cancer Research Technology Ltd. and the Institute of Cancer Research, both of London. Vernalis will pay an up-front fee, potential milestones and royalties on the inhibitors, which it is developing in collaboration with the Novartis Institute for Biomedical Research. Meanwhile, Vernalis announced its migraine treatment frovatriptan was launched in Italy by its partner Menarini Group, bringing the number of European countries where the drug is on the market to six.

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