• Affinium Pharmaceuticals Inc., of Toronto, said a team of scientists, led by Affinium co-founder Jack Greenblatt, tagged a total of 847 proteins, including 198 soluble non-ribosomal proteins essential for life in at least one bacterial species. Results of the project are reported in the Feb. 3, 2005, edition of Nature.

• Affymetrix Inc., of Santa Clara, Calif., and Institut Curie, of Paris, formed an alliance that will use GeneChip microarray technology in large-scale clinical studies to produce genetic signatures for different types of cancer and be used to develop diagnostic tests. Institut Curie will conduct the studies from its translational medicine division. The first two projects will focus on identifying genetic markers for cancer prognosis.

• Anadys Pharmaceuticals Inc., of San Diego, initiated a Phase I trial in healthy volunteers of ANA975, an oral prodrug of Anadys' small-molecule compound isatoribine, an agonist of Toll-like receptor 7. Clinical results of isatoribine have demonstrated a statistically significant viral load reduction in hepatitis C patients by activating innate immunity. The study will involve 18 subjects in the UK.

• Argos Therapeutics Inc., of Durham, N.C., was awarded a $1 million grant from the Alliance for Lupus Research for development of a therapeutic antibody for systemic lupus erythematosus based on research conducted at the Baylor Institute for Immunology Research. Argos uses its expertise in dendritic-cell biology to develop therapeutic vaccines in the areas of cancer, infectious diseases, autoimmune disorders and transplantation.

• Biota Holdings Ltd., of Melbourne, Australia, said that its suit against GlaxoSmithKline plc, of London, relating to Biota's influenza antiviral, Relenza, was on track and that at a hearing in the Victorian Supreme Court on Monday, a firm timetable was set for the next key phases of the litigation. Biota is suing GSK for failing to adequately support Relenza after the launch of the drug in 1999.

• The Coalition for Pulmonary Fibrosis in San Jose, Calif., awarded the University of Michigan Health System's Division of Pulmonary and Critical Care Medicine a $60,000 restricted gift to investigate two approaches for treating pulmonary fibrosis. Research initiatives will include a Phase I/II trial of tetrathiomolybdate in patients with IPF refractory to previous therapy, and a clinical trial examining the role of circulating fibrocytes in the pathogenesis of pulmonary fibrosis.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., expanded its ability to provide genetic tests for variants of cardiac ion channel proteins involved in drug-inducted cardiac arrhythmias after receiving exclusive commercial rights to Vanderbilt University's patent. The patent claims screening patients for susceptibility for drug-induced cardiac arrhythmias by testing for the presence of common polymorphism in KCNE1.

• Generex Biotechnology Corp., of Toronto, reported results of a preliminary Phase IIb study of Oral-lyn, the company's oral insulin spray formulation. The study showed, in a comparison of the postprandial glycemic control between the Oral-lyn regimen and injected regular human insulin, that Oral-lyn administered in a divided dose produced pharmacokinetic and glucodynamic profiles comparable to that produced by injected regular human insulin.

• INO Therapeutics Inc., of Clinton, N.J., entered an agreement with Forest Laboratories Inc., of New York, to co-promote Infasurf using its sales force, which calls on neonatal intensive-care units. Infasurf is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS and the treatment of premature infants who develop RDS.

• La Jolla Pharmaceutical Co., of San Diego, completed its previously announced public offering of 12.25 million shares of common stock. The company reported net proceeds, after expenses, at about $15.8 million, of which a portion will be used to fund ongoing clinical trials of its lead product, Riquent (abetimus sodium), for lupus renal disease. (See BioWorld Today, Jan. 31, 2005.)

• NexMed Inc., of Robbinsville, N.J., initiated the U.S. Phase I study for NM100060, the company's nail lacquer treatment for onychomycosis. The double blind, placebo-controlled study is designed to assess the pharmacokinetic properties, safety and tolerability of the product in 45 patients diagnosed with onychomycosis. NexMed is in talks with pharmaceutical companies for licensing and co-development rights to the product in the U.S. and abroad.

• Norwood Abbey Ltd., of Melbourne, Australia, said that its investigational new drug application, which was filed in December, was accepted by the FDA. The IND relates to the beginning of the company's first autologous bone marrow transplant trial in the U.S. with partner TAP Pharmaceutical Products Inc., of Lake Forrest, Ill. The key endpoints in the trial will be the determination of immune responses to four vaccines as an indicator of improved immune function in patients undergoing an autologous BMT. It is expected that the trial will begin within the next three months.

• PharmaDesign Inc., of Tokyo, announced that its representative Summit Pharmaceuticals International, also of Tokyo, licensed PharmaDesign's GPCR Peptide Ligand Library to Whitehouse Station, N.J.-based Merck & Co. Inc. Financial terms were not disclosed. PharmaDesign is a genomic drug discovery company that uses bioinformatics and silico protein science.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., and its marketing partner, Teva Pharmaceutical Industries Ltd., of Jerusalem, agreed to a partial settlement of their disputes with Novo Nordisk A/S, of Bagsvaerd, Denmark, over human growth hormone intellectual property. The three parties have granted each other cross-licenses to any patents covering the hGH active ingredient. An appeal of a district court judgment regarding one portion of the dispute will continue, as will an interference proceeding in the U.S. Patent and Trademark Office. Teva and Savient have dropped their claims for attorneys' fees and damages for wrongful injunction.

• Serono International SA, of Geneva, reported a 17 percent increase in annual product sales - about $2.2 billion - in the company's fourth-quarter and full-year report. Fourth-quarter sales grew 16.4 percent to $604 million. Of its marketed products, the company reported the largest sales increase for the multiple sclerosis drug Rebif, which brought in about $1.1 billion in 2004, a 33.1 percent increase from the previous year. Serono said its 2005 outlook for product sales is an increase of 10 percent to 15 percent, with estimated total revenues at $2.6 billion and net income between $520 million and $540 million.

• Stem Cell Sciences Ltd., of Edinburgh, Scotland, received a £1.2 million (US$2.3 million) from the DTI Technology Program to fund a consortium including stem cell experts in industry and academia. The program is aimed at developing high-throughput cell screening to speed the discovery of drug-based regenerative medicines using embryonic stem cells.

• Viventia Biotech Inc., of Toronto, and Affitech A/S, of Oslo, Norway, achieved the first two research milestones in their collaboration, involving Affitech's discovery and selection of several antibodies in a specific cancer area using its Cell Based Antibody Selection technology and Viventia's ImmunoMine antibody-profiling platform. The milestones triggered an undisclosed research payment to Affitech.

• XOMA Ltd., of Berkeley, Calif., priced $60 million in 6.5 percent convertible senior notes due 2012 in a private placement to qualified institutional buyers. The notes are convertible into XOMA common shares at an initial conversion rate of about 533.5 common shares per $1,000 in notes. XOMA may redeem the notes after Feb. 6, 2008, and it will use proceeds for general corporate purposes.

• Zonagen Inc., of The Woodlands, Texas, said the underwriters of its recent follow-on offering have exercised in full the overallotment option, bringing the total shares offered to about 5.1 million and the total gross proceeds raised to $20.2 million. Total net proceeds were $18.1 million. Punk Ziegel & Co. and WR Hambrecht + Co. acted as underwriters in the offering. (See BioWorld Today, Jan. 28, 2005.)

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