• AnalytiCon Discovery GmbH, of Potsdam, Germany, began a multiyear collaboration to identify novel drug candidates in oncology with the Experimental Therapeutics Center at Memorial Sloan-Kettering Cancer Center. AnalytiCon specializes in structurally, fully elucidated natural-product libraries. Financial details were not disclosed.

• Antisoma plc, of London, acquired exclusive rights to BC1-IL12, which it was developing in collaboration with EMD Lexigen Research Center Corp., an affiliate of Merck KgaA, of Darmstadt, Germany. Antisoma will accelerate development of the drug, which has been renamed AS1409 and uses Antisoma's tumor-targeting antibody BC1 to deliver the cytokine IL-12. AS1409 will be prepared for clinical trials, building on preclinical data that showed it reduced the growth of colon, prostate and skin cancers in mice.

The Atomic Energy Commission's Functional Genomics Department at Genopole, France's national biotechnology science and business park in Evry, identified the cellular mechanisms responsible for Clouston's syndrome, a rare dermatological disease of genetic origin that is characterized by a congenital absence of sudoriparous glands, resulting from mutations affecting the gene coding for connexin 30, a membrane protein that exists in the cells of the palm of the hand, the sole of the foot and hair follicles. Research has established that, while the mutated connexins are present at the cell membrane level and permit the flow of chemical molecules from one cell to another, they die within 24 hours because they are permeable to adenosine triphosphoric acid, whereas normal ones are not. The researchers plan to determine whether the process they discovered in vitro exists in vivo.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it received fast-track designation from the FDA for its investigational new drug application for its smallpox vaccine candidate Imvamune. Ongoing studies of the third-generation product are designed to evaluate its immune response in comparison to Dryvax, as well as to test the vaccine in special populations for which Dryvax is contra-indicated.

• BioVet Inc., of Tokyo, confirmed that the Ministry of Agriculture, Forestry and Fisheries of Japan granted regulatory approval for an oral interferon treatment of rotavirus in cattle. BioVet is collaborating on the treatment with Amarillo Biosciences Inc., of Amarillo, Texas. Rotavirus diarrhea is a major cause of disease and death in animals and humans. The approval is for low-dose oral administration of human interferon-alpha supplied by Hayashibara Biochemical Laboratories. It will be launched in Japan in September. Amarillo, which owns the distribution rights to HBL interferon for animal health outside Japan, will receive a royalty on sales in Japan.

• Cancer Research Technology, of London, the technology transfer arm of Cancer Research UK, agreed to an exclusive license with Genentech Inc., of South San Francisco, giving Genentech rights to an oncology target discovered by Cancer Research UK. Genentech will evaluate protein therapeutics directed against the undisclosed target.

• CellFactors plc, of Cambridge, UK, entered administration following its failure to raise additional equity finance. Stephen Hull and John Twizell of Geoffrey Martin & Co. were appointed as the company's joint administrators. CellFactors has raised a total of £7 million (US$12.9 million) since its 1997 founding. CellFactors has put its assets up for sale, including its lead product Skeletex, a biological matrix derived from human cells designed to induce vascularized bone growth.

• Elan Corp. plc, of Dublin, Ireland, and Wyeth, of Madison, N.J., presented Phase IIa results of AN-1792 for Alzheimer's disease at the 9th International Conference on Alzheimer's Disease and Related Disorders in Philadelphia. AN-1792 is a synthetic form of the beta-amyloid peptide. Dosing was halted in 2002 when encephalitis was found in a subset of patients, but the trial remained blinded and patients were followed through December of that year. Examining the beta-amyloid immunotherapy approach, researchers found less worsening on a neuropsychological test battery, as well as a reduction of beta-amyloid plaque in three patients. Also, Elan and Biogen Idec Inc., of Cambridge, Mass., said the FDA accepted their biologics license application for Antegren (natalizumab). Last month, the agency designated the product for priority review and accelerated approval for the treatment of multiple sclerosis. As a result, the companies expect FDA action about six months from the submission date.

• Evotec OAI AG, of Hamburg, Germany, said it was selected by Morphochem AG, of Munich, Germany, as a preferred partner for the chemical and pharmaceutical development of one of its dual-action antibiotics. Evotec will support Morphochem with development through preclinical development and into Phase I trials using its integrated chemical and pharmaceutical development platform, EVOdevelop.

• IrsiCaixa, of Barcelona, Spain, and the CombiMatrix Group unit of Acacia Research Corp., of Newport Beach, Calif., entered an expanded three-year research, development and licensing agreement. They have chosen two siRNA candidates for preclinical development against HIV. CombiMatrix and its potential partners will pursue the preclinical development of the noted sequences with irsiCaixa providing research, as appropriate. CombiMatrix will provide irsiCaixa research funding, and could pay milestones and royalties. The agreement also covers additional virology work at irsiCaixa, including hepatitis C.

• Jerini AG, of Berlin, received fast-track designation from the FDA for Icatibant as a subcutaneous treatment of hereditary angioedema. Patients treated with the drug have reported fast, reliable relief of symptoms, and they experienced no drug-related adverse events, the company said. Pivotal trials will be initiated in the third quarter. Icatibant is a specific peptidomimetic bradykinin B2 receptor antagonist.

• KeyNeurotek AG, of Magdeburg, Germany, added three members to its supervisory board: Axel Kleemann, Axel Smend and Guenter Frankenne. KeyNeurotek specializes in treatments for diseases of the central nervous system.

• Medical Marketing International (MMI) Group plc, of Cambridge, UK, will be granted a European patent on an HIV/AIDS therapy being developed by Viratis Ltd., a joint venture between MMI and King's College and Queen Mary College, both of London. The treatment is based on ribozyme technologies that block the formation of cellular receptors required for the HIV virus to enter a cell. Studies by Viratis showed that a high level of expression of a particular ribozyme in human cells corresponded with a decrease in receptor levels and a reduction in viral load when challenged with HIV.

• Neuro3d SA, of Mulhouse, France, extended its research collaboration with Johnson & Johnson Pharmaceutical Research & Development in Beerse, Belgium, a unit of Johnson & Johnson, of New Brunswick, N.J., after the latter identified a compound for further characterization from Neuro3d's libraries. Neuro3d said that the compound is outside its main area of focus, which is in the psychiatric arena.

• Neuropharma SAU, of Madrid, Spain, said preclinical data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed that prolonged oral treatment of Tet/GSK3Beta mice with two GSK3Beta inhibitors induced a dose-dependent significant decrease on tau phosphorylation in the hippocampus, where the transgene is most highly expressed, while not showing any apparent clinical signs. The company said the data prove the products' potential as a new therapeutic agent for Alzheimer's disease and other central nervous system disorders. Neuropharma is wholly owned by Zeltia SA, also of Madrid.

• NeuroSearch A/S, of Ballerup, Denmark, initiated two Phase II studies of NS1209, its candidate for acute treatment of refractory status epilepticus, a condition characterized by long-lasting seizures. The two studies are designed to involve 60 patients in 10 clinical centers in Denmark, Sweden and Finland. Each trial will compare NS1209 to standard therapy.

• Phares Technology BV, of Muttenz, Switzerland, and Inyx Inc., of New York, signed a letter of intent for Inyx to acquire a patented platform technology that would enable the company to develop inhalation therapy drugs, including combination drugs, delivered in aerosol formats. Phares is the parent company of Phares Drug Delivery AG, which developed the technology that uses a lipid-binding matrix to deliver incompatible or unstable drug substances to mucosal membranes. As part of the agreement, Phares will provide related product development and technology support.

• Phytopharm plc, of Godmanchester, UK, said the FDA granted orphan drug status to Myogane, its treatment for amyotrophic lateral sclerosis (ALS). Myogane has completed a Phase I trial in healthy volunteers. In an animal model of ALS, Myogane delayed the loss of muscle strength and extended survival time.

• Pierre Fabre Medicament SA, a division of Paris-based bioMerieux Pierre Fabre, milnacipran's originator, plans to set up a second milnacipran production site in Castres, France. The site would increase the production capacity for the molecule. Pierre Fabre has said that the additional production unit is expected to be operational in 2008. Earlier this year, Cypress Bioscience Inc., of San Diego, and Forest Laboratories Inc., of New York, reported they had entered a collaboration for the development and marketing of Cypress's milnacipran, licensed from Pierre Fabre Medicament, for indications in the U.S. market.

• San Luigi Gonzaga Hospital in Torino, Italy, said one of its researchers published findings in this month's Journal of the Neurological Sciences showing that relapsing-remitting multiple sclerosis patients who are treated with high-dose, high-frequency interferon beta-1b (Betaferon/Betaseron, from Chiron Corp. and Berlex Laboratories Inc.) should stay on the regimen and avoid switching to low-dose, once-weekly interferon beta-1a (Avonex, from Biogen Idec Inc.), even in the absence of clinical or MRI signs of disease activity. Data showed that 23 percent of those on the interferon beta-1a regimen remained free from relapses, compared with 79 percent of those receiving interferon beta-1b (p=0.006). Also, the relapse rate was significantly higher in those receiving interferon beta-1a (p=0.03), and the time to first relapse was significantly shorter (p=0.001).

• Sinovac Biotech Ltd., of Beijing, received $1.2 million in research funding from the Chinese state government for its inactivated severe acute respiratory syndrome vaccine development program. To date, Sinovac said it has received $2.2 million in government support for its SARS vaccine program.

• Tissera Inc., of Tel Aviv, Israel, said it became aware of a patent application filed by Marc Hammerman at Washington University in St. Louis for the development of diabetes mellitus therapy based on transplanted embryonic pancreatic-precursor cells. After analyzing the patent, Tissera determined it might restrict the company's freedom to implement its pancreatic application. The company has commissioned a legal expert. It does not believe the patent will impact other applications related to the liver, spleen and other organs.

• Tripep AB, of Huddinge, Sweden, said a microdosing study in healthy volunteers indicated that its HIV drug, alphaHGA, is orally available and has favorable pharmacokinetic properties, with a plasma half-life of 10 hours. The company plans to conduct Phase I/II studies in HIV-infected individuals later this year or early next year. It has appointed NCB Stockbrokers, of Dublin, Ireland, to evaluate the feasibility of a listing on the Alternative Investment Market of the London Stock Exchange in advance of the clinical trial.

• Vascular Biogenics Ltd., of Tel Aviv, Israel, signed a business development agreement with Cleveland-based BioEnterprise Corp., which will support the company's U.S. fund raising. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic, will be chairman of Vascular's clinical advisory board. Vascular plans to begin clinical trials in 2005 for an anti-inflammatory approach to atherosclerosis and a targeted, gene-mediated delivery system to treat solid-tumor cancers. Vascular was founded in 2000 and employs 20 people.

• Xenome Ltd., of Queensland, Australia, said that it began a Phase I trial of its neuropathic pain drug Xen2174. The trial is a randomized, placebo-controlled, double-blind, dose-escalating study involving up to 20 healthy male volunteers. The primary purpose of the trial is to evaluate the safety and tolerability of Xen2174 following intravenous administration.

• Y's Therapeutics Co. Ltd., of Tokyo, said it submitted applications to German regulatory authorities to begin Phase II trials of its two most advanced projects, YSIL6 for rheumatoid arthritis and YSTH2 for asthma. Both studies are randomized, double-blinded, placebo-controlled, dose-ranging, multinational, multicenter trials designed to test the small molecules' safety and efficacy in their respective indications. The privately held company also said it would establish two subsidiary companies in Germany and the U.S.

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