• 4SC AG, of Martinsried, Germany, and Mutabilis SA, of Paris, signed a partnership to identify new molecules as a basis for drug discovery against an undisclosed target provided by Mutabilis. 4SC will use its virtual high-throughput screening technology, 4Scan, to screen a database of 4.6 million small organic molecules to identify active compounds that bind to the target. Mutabilis will get a selection of the best-ranked molecules for biological testing and evaluation. 4SC receives undisclosed research funding and is eligible for milestone payments.

• Acambis plc, of Cambridge, UK, said the FDA designated its joint project with Baxter Healthcare Corp., of Deerfield, Ill., to develop a modified vaccinia Ankara (MVA) vaccine a fast-track program. MVA is a weakened form of smallpox vaccine being developed for use in people for whom the traditional smallpox vaccine is contraindicated. Acambis is co-developing its MVA vaccine candidate with Baxter under a contract with the U.S. National Institute of Allergy and Infectious Diseases.

• Alizyme plc, of Cambridge, UK, said it is "closing in on the finishing line" for its three lead programs with discussions on the design of Phase III studies for irritable bowel syndrome and ulcerative colitis drugs now under way with regulators in the U.S. and Europe, respectively, and permission granted for a second Phase IIb trial of its lipase inhibitor in obese diabetics. Alizyme initiated the regulatory process with the FDA for a Phase III study of renzapride, a 5HT4 full agonist/5HT3 antagonist, following a U.S. Phase IIb trial in constipation-predominant IBS at the Mayo Clinic. The company expects the go ahead before the end of the year. The company already agreed with European regulators that it needs to complete only a single Phase III registration study for Colal-Pred in ulcerative colitis. Colal-Pred is a formulation of the steroid prednisolone that is not digested by enzymes in the stomach, passing into the colon before it is released. Alongside renzapride, Alizyme has another potential blockbuster in ATL-962, a lipase inhibitor that has completed a Phase IIb trial in obese subjects who were otherwise healthy. The company is expanding the label with a 600-patient European trial in obese diabetics, after demonstrating in a Phase I trial in healthy subjects that ATL-962 does not interact with the diabetes treatment metformin.

• Amgen Inc., of Thousand Oaks, Calif., said the European Commission approved expanded marketing authorization for Aranesp (darbepoetin alfa) in the European Union following a positive opinion from the European Committee for Medicinal Products for Human Use in July. The decision allows extended Aranesp dosing intervals of once every three weeks for anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month administration for anemia in chronic kidney disease patients not on dialysis. Aranesp was first granted EU marketing authorization and FDA approval in 2001 for anemia associated with chronic renal failure.

• Arexis AB, of Gothenburg, Sweden, obtained funding under the European Union's Sixth Framework Program to move its treatment for reducing developmental deficits in preterm infants into a Phase II trial in 2005. The company is developing a recombinant form of human bile salt-stimulated lipase (BSSL), an enzyme that is destroyed by pasteurization and is absent from infant formula, as a food ingredient for preterm infants. It plays a role in the metabolism of a large spectrum of lipids in food. Arexis is also planning to move BSSL into a Phase III trial in adult cystic fibrosis patients with pancreatic insufficiency.

• aRigen Inc., of Tokyo, began a Phase I study of WAP 8294A2, an antibiotic with antimicrobial efficacy against methicillin-resistant Staphylococcus aureus and other drug-resistant strains. The study is designed to provide information on the safety, tolerability and pharmacokinetic profile of the compound as an intravenous infusion. All rights for the product's future development have been assigned to privately held aRigen, which was formed to acquire and develop assets from Japanese pharmaceutical firms, public research institutes and universities.

• Biocompatibles International plc, of Farnham, UK, released positive safety data from Phase I trials of its drug-eluting bead in liver cancer. The drug delivers the chemotherapeutic doxorubicin in a controlled-release formulation to the liver through the hepatic artery, in combination with an embolic agent to block blood flow and seal in the drug. Data for plasma levels of doxorubicin over the first 72 hours in 15 patients demonstrated a reduction in systemic exposure, compared to the standard treatment of administering doxorubicin and the embolic agent separately.

• Biotica Technology Ltd., of Cambridge, UK, appointed Mark Bodmer CEO, as it embarks on its second funding round. Bodmer comes from Lorantis Ltd., also of Cambridge, where in the past five years he raised £45 million (US$81.3 million) in three private rounds. Biotica specializes in the discovery and development of polyketide drugs using targeted alterations of polyketide biosynthetic pathways.

• Biovitrum AB, of Stockholm, Sweden, acquired rights to a set of anti-obesity drug leads discovered by its partner, BioFocus plc, of Chesterford Research Park, UK, as part of a research collaboration entered in 2001. The program has yielded a set of compounds that are potent and selective inhibitors of a G protein-coupled receptor thought to be associated with regulation of body weight. Biovitrum now plans to take those compounds into preclinical development. BioFocus will receive an up-front payment, along with potential milestones and product royalties.

• BioXell SpA, of Milan, Italy, plans to move its treatment for benign prostatic hyperplasia into a dose-ranging Phase IIb trial early next year, following a Phase IIa trial involving 120 subjects that yielded promising results. The drug, BXL-628, was well tolerated and the primary endpoint of prostate volume reduction was met with a high degree of significance, the company said. Those receiving the drug exhibited a reduction in prostate volume of 7.2 percent vs. those in receipt of placebo. The company also will soon commence Phase IIa trials of BXL-628 in patients suffering from overactive bladder, interstitial cystitis and in a third undisclosed indication.

• Cardiff University in Wales said its researchers reported findings at this week's British Pharmaceutical Society Conference in Manchester, UK, detailing their use of the HPMA (N-[2-hydroxypropyl] methacrylamide) copolymer to deliver cancer drugs to a tumor site. They found that it is possible to deliver chemotherapy and hormonal drugs at the same time, attached to the same carrier, and early work suggests that the combination is more effective than giving the drugs separately.

• Clavis Pharma AS, of Oslo, Norway, said its cancer drug CP-4055 exhibited preliminary signs of efficacy in a Phase I trial of 24 patients with advanced malignant melanoma, lung cancer or ovarian cancer. Eight of the subjects who had failed to respond to other therapies exhibited some cessation of tumor growth. Clavis already has initiated a dose-finding study in Belgium and France, while combination studies with other drugs are being planned. CP-4055 is a fatty-acid derivative of the cytotoxic agent cytarabine, which Clavis developed using its lipid vector technology.

• Cyclacel Group plc, of Dundee, Scotland, granted Corgentech Inc., of South San Francisco, an exclusive license to use its Penetratin endonuclear delivery system with Corgentech's Transcription Factor Decoy (TF Decoy) technology platform. The Penetratin system is a peptide with carrier properties for delivery into cells, while Corgentech's TF Decoy technology is a new class of therapeutics that blocks the activity of multiple genes linked to a disease. Penetratin enables systemic cellular delivery by chemically linking to TF Decoys, and actively transporting the TF Decoy therapy into cells. Corgentech will be responsible for the development and commercialization of TF Decoys combined with a Penetratin peptide. Cyclacel will receive an up-front payment, milestone payments and royalties if licensed products are commercialized. No further financial terms were disclosed.

• Cytos Biotechnology AG, of Schlieren, Switzerland, reached its targeted enrollment of 300 smokers in a Phase II trial of its lead Immunodrug candidate, CYT002-NicQb. The primary endpoint of the study, which began in January, is continuous abstinence from smoking, which is determined by self-reporting and confirmed by measuring a long-lasting metabolite of nicotine called cotinine. The company expects initial results in the second quarter of next year.

• DakoCytomation A/S, of Copenhagen, Denmark, began shipping its CyAn ADP instrument platform for flow-cytometry analysis. It provides access to more than 300 research antibodies optimized for the platform.

• Evotec OAI AG, of Hamburg, Germany, signed a deal with Hydra Biosciences Inc., of Cambridge, Mass., to advance the discovery of ion channel modulators. Evotec will provide Hydra biology and screening services to identify active compounds against an ion channel target being developed by Hydra. Evotec will produce reagents, develop assays, screen compounds and characterize hits generated by the program.

• Galapagos Genomics NV, of Mechelen, Belgium, created a new business unit for its viral-based discovery and validation service. The unit will operate under the name Galadeno from the Galapagos facility in Leiden, the Netherlands. The drug discovery business will be conducted from the Mechelen facility and continue to trade under the name Galapagos. Galadeno will offer individual adenoviral-based siRNA and full-length gene reagents for drug target discovery and validation.

The German parliament failed to agree on a version of a law to implement the EU's directive on agricultural biotechnology, which should have been enacted into national law by 2002. In July, the upper house defeated a draft passed by the lower house. The two houses differ on the amount of liability farmers who plant genetically modified crops should bear if nearby organic farms are "contaminated" by the modified plants. The lower-house draft has been criticized by many of Germany's leading research institutions as inhibiting scientific investigation. It also has drawn scrutiny from the EU for not implementing its directive. An arbitration committee will meet in October.

• Glenmark Pharmaceuticals SA, a wholly owned subsidiary of Glenmark Pharmaceuticals India, of Mumbai, India, could gain up to $190 million after entering a collaborative agreement centered on its PDE4 inhibitor, GRC 3886, with Forest Laboratories Inc., of New York. Forest will develop, register and commercialize GRC 3886 for the North American market, while Glenmark will retain commercialization rights for the rest of the world. GRC 3886, in development for chronic obstructive pulmonary disorder and asthma, is entering Phase I trials in the UK. Forest will pay Glenmark an up-front payment, followed by milestones if the development and commercialization of the product is successfully completed in the North American market. Should the product be commercially launched, Glenmark would earn a royalty in the mid-teens, and would supply all active pharmaceutical ingredients to Forest.

• Glycart Biotechnology AG, of Zurich, Switzerland, began a collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to discover therapeutic antibodies using Glycart's technology. Roche will have options on developing and marketing antibodies that Glycart creates from an undisclosed product candidate. Glycart will receive an up-front fee and research funding, as well as potential milestone payments and royalties.

• Immuno-Designed Molecules SA, of Paris, received FDA approval to begin a clinical trial of Uvidem, its therapeutic vaccine for melanoma. The Phase II study will enroll 37 patients with Stage III or IV melanoma, whose disease is progressing with measurable or evaluable lesions. The product, developed in partnership with Sanofi-Aventis Group, also of Paris, consists of mature dendritic cells loaded with lysates of tumor cell lines.

• Insitut Curie in Paris identified and characterized the genetic mutation associated with Ewing's sarcoma, a bone cancer affecting the young. It discovered that an accidental exchange of genetic material between two chromosomes leads to the formation of a mutated gene, which produces an abnormal protein called EWS/FLI-1. That protein reduces IGFBP-3, which is reduced in the tumor cells where it is expressed normally in the absence of the altered protein. The protein manufactured by the IGFBP-3 gene is thought to block insulin-like growth factor-1 (IGF-1), a cellular messenger that controls cell proliferation and apoptosis. IGFBP-3 could be a therapeutic target for blocking the abnormal cell proliferation induced by IGF-1 and hence for the treatment of Ewing's sarcoma.

• Insitut Pasteur in Paris discovered that there are three genetic factors that determine if stem cells will become muscle tissue as opposed to bone, skin or other tissue. It had been assumed that only two genes, Myf5 and Myod, caused stem cells to become muscle cells, but the Pasteur researchers say a third gene, Mrf4, plays the predominant role in the process. They suggested that the discovery could result in advances in gene and cell therapies for muscular dystrophy.

• Inte:Ligand GmbH, of Vienna, Austria, launched a drug-design software package called ilib diverse. The technology can be used to create computer-generated molecules and test their ability to pass the blood-brain barrier or be orally administered.

• KuDOS Pharmaceuticals Ltd., of Cambridge, UK, said its partner Novacea Inc., of San Francisco, Calif., began a Phase I dose-escalation study of AQ4N, licensed from KuDOS in December 2003. AQ4N, a topoisomerase-II inhibitor and DNA intercalator, is a first-in-class hypoxic cell-activated chemotherapy that is changed to its toxic form when it reaches hypoxic tumor cells. In June, KuDOS released interim results from a UK trial of 13 of an expected 22 patients with advanced esophageal carcinoma receiving palliative radiotherapy. The results showed AQ4N was well tolerated, with favorable pharmacokinetics and that no sensitization of healthy tissues to radiotherapy was observed.

• LemnaGene SA, of Lyon, France, opened its new laboratory and biomanufacturing facility in the incubation space for new projects located at the Ecole Normale Superieure de Lyon. The space will allow LemnaGene to provide a full range of biomanufacturing services to the pharmaceutical, vaccine, veterinarian, diagnostic, nutraceutical and industrial protein markets. LemnaGene also produced its first transgenic Spirodela containing genes of interest to industrial partners. LemnaGene was established in October 2003 and focuses on the aquatic plant Spirodela from the Lemnaceae family.

• Medical Marketing International, of Cambridge, UK, raised £2.3 million (US$4.2 million) through a placing of 3.35 million shares with new and existing shareholders at 70 pence per share. The money will fund drug development. The 70 pence placing was a 9.4 percent premium to the closing price on Sept. 22. The shares rose 2.5 pence to 67.5 pence when the placing was announced on Sept. 24.

• MorphoSys AG, of Martinsreid, Germany, formed a marketing cooperation with GeneFrontier Corp., of Tokyo, to establish MorphoSys' HuCAL technology in the Japanese life science market. Under the multiyear collaboration, the parties will invest in customer development and marketing in Japan as part of a wider MorphoSys effort to expand geographically into new markets. Financial terms were not disclosed.

• PA Consulting Group, of London, is selling the remaining 90 percent of a drug delivery technology company called Meridica Ltd., of Cambridge, UK, to Pfizer Inc., of New York, which will pay $125 million and a contingent payment. Almost a year ago, Pfizer purchased a 10 percent interest in the company and licensed the rights to Meridica's dry-powder inhaler. The transaction is subject to normal conditions and is expected to close next quarter.

• Phares Technology BV, the parent company of Phares Drug Delivery AG, of Muttenz, Switzerland, sold to Inyx Inc., of New York, its platform technology to enable Inyx to develop inhalation therapy drugs, including combination drugs, delivered in aerosol formats. Financial terms were not disclosed. Phares will provide related product development and technology support.

• Pharmion Corp., of Boulder, Colo., said the Agency for the Evaluation of Medicinal Products accepted for review the company's marketing authorization application for Vidaza for the treatment of myelodysplastic syndromes. Vidaza was granted orphan product designation by the EMEA. Vidaza is the first drug approved in the U.S. for MDS, and it was approved for all five subtypes of MDS on May 19.

• Protherics plc, of Runcorn, UK, announced the disposal of early stage products and patents, along with the R&D facility of Enact Pharma plc, to two start-up companies. Protherics acquired Enact in June 2003 to access the late-stage products Voraxaze and NQ02. The Enact R&D facility and staff have been taken on by Morvus Technology Ltd., with Protherics receiving an equity stake valued at £150,000 (US$270,971) and the right of first refusal to license certain products developed by Morvus in the next five years. The disposal will save Protherics £450,000 per year. Protherics also assigned patents to NanoMor BioMedical Ltd. in return for an equity stake of 2 percent and future royalties of 2 percent on any products. The new companies were founded by Tony Atkinson, former CEO of Enact.

• Serono SA, of Geneva, will market the psoriasis drug Raptiva in Europe in the fourth quarter, after receiving authorization from the European Union in patients with moderate to severe chronic plaque psoriasis for whom other systemic treatments or phototherapy have failed. The Swiss company is to launch the product in selected countries, including Germany and the UK, before year's end, and roll it out in the rest of the EU through 2005. Raptiva has been available in the U.S. since November 2003, and also is on the market in Switzerland and Argentina. It recently was approved in Mexico and Brazil. In the U.S. Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif., hold rights to the product.

• Switch Biotech AG, of Neuried, Germany, filed for insolvency on Sept. 3. Due to an unexpected outflow of funds at the end of August, the financial reach of the liquid funds was reduced substantially, the company said. Considering the current difficult climate at the European venture capital markets, it said, the remaining financial reach was too short to close the anticipated round of financing in time. During the insolvency process, Switch Biotech will focus on certain dermatological disease areas, such as psoriasis and vitiligo, and will restructure the organization accordingly, with the intention to further advance those activities in a new company. Assets, such as the patent portfolio in the area of diabetic foot ulcers, will be divested to third parties, the company said.

• Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, and FibroGen Inc., of South San Francisco, entered an agreement in which Fibrogen will license FG-2216, an erythropoietic small molecule that is undergoing clinical development as a treatment for anemia. Yamanouchi gains exclusive rights to develop and market FG-2216 and certain other FibroGen compounds with a similar mechanism of action to treat anemia in Japan. FibroGen retains rights in the rest of the world. Financial terms were not disclosed.

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