• 4SC AG, of Martinsried, Germany, began Phase I trials of SC12267, its first small-molecule candidate for rheumatoid arthritis. The compound will be examined in 56 healthy volunteers divided into seven groups to evaluate the safety, tolerability and pharmacokinetics of the agent under increasing dosage.

• Aeres Biomedical Ltd., of London, and Peregrine Pharmaceuticals Inc., of Tustin, Calif., entered an agreement to humanize one of Peregrine's vascular targeting agent (VTA) antibodies. Peregrine will provide the murine VTA antibody to Aeres, which will use its humanization technology to provide a humanized VTA clinical candidate. Financial terms were not disclosed.

• Alliance Pharmaceuticals Ltd., of Johannesburg, South Africa, and Neopharm Ltd., of Petach-Tikva, Israel, established agreements with Barrier Therapeutics Inc., of Princeton, N.J., for the marketing, sales and distribution of Zimycan, Barrier's lead topical ointment for Candida-associated diaper dermatitis. Alliance will be responsible for marketing, sales and product distribution in the UK and Scandinavia, while Neopharm will embark on the same initiatives in Israel and Turkey. Financial terms were not disclosed.

• Arakis Ltd., of Cambridge, UK, said ED1612 entered a Phase I trial to investigate it as a treatment for chronic benign pain. ED1612 is based on an existing drug that is marketed for a different indication. Arakis believes it has the ability to increase the analgesic efficacy of mild opioids, thus avoiding, or delaying, the need for stronger agents such as morphine. There also is evidence ED1612 reduces the nausea associated with opioids, it said.

• Ariana Pharmaceuticals, of Paris, extended its collaboration with the Centre National de Recherche Scientifique (CNRS). Ariana negotiated exclusive access to use artificial intelligence technology developed jointly with the CNRS lab in Montpellier, France. The collaboration will focus on developing Ariana's artificial intelligence technology that it said has the potential to decrease drug discovery timelines by improving the prediction of the quality profile of molecules.

• Biotica Technology Ltd., of Cambridge, UK, moved all its research and support facilities to Chesterford Research Park. The company is focused on discovering pharmaceuticals through a targeted alteration of biosynthetic pathways, producing natural products.

• Cenix BioScience GmbH, of Dresden, Germany, entered a research collaboration with Bayer HealthCare AG, a subgroup of Bayer AG, of Leverkusen, Germany, to screen all known human druggable genes using RNA interference (RNAi) to identify and validate new therapeutic drug targets for several disease indications. Using cell-based assays co-developed with Bayer, Cenix will apply its genome-based high-throughput RNAi screening platform to more than 6,000 genes in less than nine months. Cenix will receive up-front payments and research funding and is eligible for downstream milestone payments, while Bayer will have the option to obtain all rights to new intellectual property generated by the project.

• CliniGenetics, of N mes, France, reported results from preclinical studies of its anti-atherothrombotic drug, Nimoxine. In treated mice, cholesterol levels dropped, atheroma plaque showed signs of regression and weight gain slowed. Nimoxine is one of several compounds identified and optimized by CliniGenetics for their ability to reduce cholesterol and triglyceride levels. It has the effect of blocking the accumulation of lipids and macrophages associated with the growth of vascular lesions in atherothrombosis, the company said.

• Codon AG, of Berlin, reported positive results from preclinical studies of its intervertebral disc-replacement materials. The results, published in the December 2003 edition of Spine, showed both the safety and effectiveness of the company's biological disc-cell transplants. The study also demonstrated the material's relevance for regeneration of degenerated discs. Codon believes that it might introduce the product to the German market in 2004.

• Cytomyx Holdings plc, of Cambridge, UK, and Clinomics Biosciences Inc., of Frederick, Md., entered a conditional agreement in which Clinomics will be acquired Cytomyx. Founded in 1998, Clinomics provides gene expression services used in the biological characterization of gene and protein targets throughout human disease. Financial terms were not disclosed.

• Cytopia Pty. Ltd., of Melbourne, Australia, and Myomatrix Therapeutics LLC, of Rensselaer, N.Y., entered a collaboration in which Cytopia will provide specific inhibitors to Myomatrix for testing in animal models. Resulting data generated in the effort will be jointly owned. The first product is being targeted at an undisclosed chronic orphan disease for which there is no current treatment, and subsequent products will target heart failure and hypertension.

• Debiopharm SA, of Lausanne, Switzerland, and Dyax Corp., of Cambridge, Mass., reported that the FDA granted orphan drug designation to the engineered protein inhibitors of human neutrophil elastase (EPI-hNE4), or DX-890, for the treatment of cystic fibrosis. DX-890 was discovered at Dyax, and Debiopharm is responsible for clinical evaluation of the compound as a treatment for CF.

• DeCode Genetics Inc., of Reykjavik, Iceland, isolated two genes as part of its alliance with Merck & Co. Inc., of Whitehouse Station, N.J., to develop drugs for obesity. The genes were identified through population and genome-wide linkage scans and association with analyses of at-risk haplotypes using genetic and clinical data from the 17,000 participants in DeCode's obesity program in Iceland. The companies now are analyzing the genes and the biological pathways they delineate to select optimal targets for the development of new drugs.

• Elan Corp. plc, of Dublin, Ireland, said it is retaining its NanoSystems drug delivery business based in King of Prussia, Pa., as well as its drug delivery business and operations located in Gainesville, Ga. The company also plans to hold onto its U.S. acute care business, which includes its Maxipime and Azactam hospital care products. Elan, which said it is entering the final stages of its recovery plan, said the businesses would generate value and provide opportunities for revenue growth and key technological capabilities. Separately, Elan said it is seeking binding arbitration in connection with a dispute regarding an agreement with Pfizer Inc., of New York, related to the discovery of small-molecule inhibitors of beta secretase for Alzheimer's disease. Elan said it terminated the agreement, which it originally entered with Pharmacia Corp. in August 2000, as a result of certain breaches by Pfizer. As a result of the termination, Elan believes that it holds the exclusive worldwide license to the intellectual property developed in connection with the research-stage program.

• ESBATech AG, of Zurich, Switzerland, and Chemical Diversity Labs Inc., of San Diego, entered an agreement in which CDL supplied ESBATech with a maximally diverse library for in vivo and in silico screening. The library is being screened by ESBATech in its yeast-based screening system and by the University of Zurich in an in silico-based approach. Financial terms were not disclosed.

• Innogenetics NV, of Ghent, Belgium, raised €23 million in a public offering, rather than the €39 million it had hoped for. The offering, which closed Dec. 9, priced at €12 per share. The original offer price was €14.10. Also, the company sold about 1.9 million shares, although it offered about 2.5 million, plus an overallotment option of 253,797, for a total of about 2.8 million shares. Existing shareholders took up 414,161 new shares, out of the more than 1 million allotted to them. However, volumes placed privately with Belgian and international institutions - 76,230 and about 1.4 million, respectively - were fully subscribed. Innogenetics CEO Phillipe Archinard said the funds, together with the company's existing cash reserves, the future cash flow from its diagnostics business and income from current and future partnering agreements, would enable it to achieve sustainable profitability by 2006.

• JSR Corp., of Tokyo, and Panacea Pharmaceuticals Inc., of Gaithersburg, Md., entered an agreement to develop and improve various assays within Panacea's HAAH oncology program. JSR will provide its expertise and capabilities in magnetic particle fabrication and surface chemistries toward the development of specialized particles designed for maximum performance in various assays that measure HAAH. The assays represent potential tools for cancer detection, diagnosis, prognosis, treatment selection and follow-up. Financial terms were not disclosed.

• Kemin Pharma, of Herentals, Belgium, entered a collaborative molecule-screening program with the U.S. Army Medical Research Institute for Infectious Diseases in Fort Detrick, Md., which will screen Kemin's library of carbohydrate-based small molecules for effectiveness against severe acute respiratory syndrome and smallpox. Kemin said its internal screenings have identified several active and selective lead molecules effective against cytomegalorvirus, hepatitis C virus and herpes simplex virus.

• ML Laboratories plc, of Warrington, UK, entered an agreement with Pliva Pharmaceuticals, of Zagreb, Croatia, to develop an asthma treatment based on Pliva's steroid PLD-177 and ML's breath-activated dry powder inhaler. ML's respiratory division, Innovate Biomed, will do the development work, for which it will receive fee income and milestone payments. It would receive royalties on sales and supply of the inhalers. PLD-177 is a new compound class with a mode of action resembling corticosteroids, but a better safety profile, ML said. Phase I studies are due to start in the first quarter of 2005.

• November AG, of Erlangen, Germany, raised about €3.4 million in additional capital in a secondary stock issue. The company placed about 658,000 new shares with institutional investors, raising the firm's available capital to about €7.5 million. November, which was founded in 1996, specializes in molecular diagnostics and biological solutions for industrial product and trademark protection.

• Novotech Pty. Ltd., of Sydney, Australia, will conduct Australia- and New Zealand-based trials for Angiogenix Inc., of Burlingame, Calif., on Angiogenix's Acclaim (organic nitrate combined with L-arginine) for chronic angina. The clinical research organization's role is part of an international team that also includes research organizations in North America and Europe.

• Onyvax Ltd., of London, signed an agreement with Scancell Ltd., of Nottingham, UK, giving Onyvax a nonexclusive license to Scancell's ImmunoBody cancer vaccine technology. ImmunoBody uses antibodies to target dendritic cells in vivo, leading to the stimulation of both helper-cell (CD4-mediated) and cytotoxic T-lymphocyte responses.

• Oxford BioMedica plc, of Oxford, UK, said it achieved the best results of any research to date in animal models of nerve repair, using its Innurex gene therapy product. Innurex consists of the company's LentiVector delivery system carrying the gene for RARbeta2, which can program nerve cells to regrow. Preliminary data, which did not include assessments of any improvements in function, were presented by Oxford BioMedica's collaborator, Malcolm Maden of King's College in London, at the 10th International Symposium of Neural Regeneration in Pacific Grove, Calif. Innurex is on course to enter clinical development in the next 12 months, it said.

• Pharmagene plc, of Royston, UK, signed an agreement giving Bayer HealthCare AG, a division of Bayer AG, of Leverkusen, Germany, access to Pharmagene's custom validation platform, a human tissue-based system for validating targets and compounds. The two-year agreement will focus initially on cardiovascular diseases, diabetes and oncology. Financial terms were not disclosed.

• Phytopharm plc, of Godmanchester, UK, is starting a Phase II study of PYM 50028 in Alzheimer's disease. The randomized, double-blind, placebo-controlled study will test once-daily oral administration of PYM 50028 in 200 patients over three months. Effects on memory, concentration and functional abilities will be evaluated. The synthetic compound is based on extracts from an Asian plant. Phytopharm said the compound offers the potential for disease modification in neurodegenerative diseases. In preclinical studies it was shown to be neuroprotective, to reverse the decrease in neuronal growth factors and to reverse neuronal degeneration observed in the ageing brain.

• PPL Therapeutics, of Edinburgh, Scotland, brought in £169,000 (US$295,250) at a public auction of the contents of its pilot production last week. Items including manufacturing and laboratory equipment remained unsold, and the company said it would continue to market those, as well as the pilot plant building.

• Qiagen GmbH, a wholly owned subsidiary of Qiagen NV, of Venlo, the Netherlands, and Artus GmbH, of Hamburg, Germany, entered a manufacturing and supply agreement. Artus will integrate Qiagen's nucleic acid sample preparation products in its diagnostic systems for use in the detection of a variety of infectious diseases, such as severe acute respiratory syndrome, herpes simplex virus 1/2, EBV and others. Those diagnostic solutions employ Artus' RealArt amplification technology. Separately, Qiagen licensed from Novartis Pharma AG, of Basel, Switzerland, an algorithm for the selection of functional target sequences for RNA interference applications. More than 300 randomly designed synthetic siRNA duplexes against 34 targets were analyzed for functionality. Based on that large data set, an automated siRNA sequence selection algorithm was developed. Extensive evaluation of the new algorithm demonstrated a performance improvement over existing design methods, Qiagen said.

• Sankyo Co. Ltd., of Tokyo, and Tularik Inc., of South San Francisco, selected a target for further development under their collaboration focused on orphan G protein-coupled receptors (GPCRs). Sankyo will fund research and preclinical development activities relating to compounds with activity against the selected target for up to four years. The parties will share equally all clinical development costs and profits in the U.S. and Europe. Tularik is entitled to milestone and royalty payments. Other financial terms were not disclosed.

• Schering AG, of Berlin, said the first multiple sclerosis patient entered the second phase of the Beyond trial, a Phase III trial aiming to enroll more than 2,100 patients. That trial will compare the efficacy of a new, higher-dose Betaferon (500 mcg) with Betaferon 250 mcg and glatiramer acetate in patients with relapsing-remitting MS. Recently, the company reported positive safety and tolerability data from the first phase of the study program examining Betaferon 250 mcg and Betaferon 500 mcg. Also, one of the treatment arms in Beyond will compare Betaferon with glatiramer acetate.

• Shire Pharmaceuticals Group plc, of Basingstoke, UK, entered an agreement to outlicense Japanese rights to Fosrenol (lanthanum carbonate) to Bayer AG, of Leverkusen, Germany. The non-aluminium, non-calcium-based phosphate binder is approved for hyperphosphataemia associated with end-stage renal disease, which afflicts about the same number of Japanese patients as in the U.S. Shire, which will receive a $12 million up-front payment and potentially more than $70 million total, called the outlicensing arrangement in line with its strategy of focusing direct operations in North America and Europe, while finding complementary partners in other worldwide territories.

• Sidec Technologies AB, of Stockholm, Sweden, entered a joint collaboration with the Center for Biophysical Sciences and Engineering at the University of Alabama at Birmingham to offer a solution for structure-based drug design. The co-marketing agreement provides for them to offer combined research services, pairing the center's structure-based drug discovery experience with Sidec's methods to define the structure-function relationships of membrane protein targets, as well as biotherapeutic molecules.

• Sigma-Tau International SA, of Rome, a subsidiary of Sigma-Tau Pharmaceuticals Inc., and InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., entered a nonexclusive co-promotion agreement. InKine's U.S. gastrointestinal sales force will promote Sigma-Tau's VSL#3 in the second sales position behind InKine's purgative product, Visicol. VSL#3 is a probiotic designed to treat certain gastrointestinal disorders, including pouchitis, an inflammation of the small bowel reservoir. InKine could receive up to $1.5 million during the one-year term based on the completion of 15,000 second-position quarterly sales calls. Additional performance-based incentives are in place to further align InKine's sales force with the success of VSL#3. The company will use a portion of the cash generated from the co-promotion agreement to fund the expansion of its gastrointestinal sales force to about 50 sales professionals.

The UK government set up a biotechnology and pharmaceutical team to attract inward investment and help UK companies trade abroad. The team will be based in Cambridge, but will work throughout the UK, providing specialist input to existing bodies such as regional development agencies.

The University of Sheffield in the UK said its researchers published Phase III findings in the Dec. 9, 2003, online edition of the Journal of Clinical Oncology showing that the use of low-dose interferon following surgery in patients with high-risk melanoma failed to improve survival. After five years, the 674-patient study showed that 63 percent of patients who received interferon following surgery and those who did not experienced a recurrence of disease. Also, 46 percent of patients in both groups died. Five-year overall and recurrence-free survival was the same for both groups, estimated at 44 percent and 32 percent, respectively.

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