• Aerovance Inc., of Berkeley, Calif., said that researchers presented preclinical data that provide strong support for moving the company's second lead product, AER-002, into the clinic. The two posters demonstrated the potential clinical benefits that AER-002 might provide to cystic fibrosis patients, such as regulation of salt levels. AER-002, also known as Bikunin and Spint2, is a protein serine protease inhibitor designed to improve tracheal mucus velocity and mucus clearance in experimental animal models. The presentations were made at the 18th annual North American Cystic Fibrosis Conference in St. Louis.

• Arexis AB, of Gothenburg, Sweden, presented Friday the results of a Phase II trial on their human enzyme replacement therapy for treatment of fat malabsorption in patients with cystic fibrosis. Arexis' study shows that cystic fibrosis patients with pancreatic insufficiency have a more rapid and efficient lipid uptake when supplemented with the enzyme BSSL (bil salt-stimulated lipase). The results were presented at the 18th annual North American Cystic Fibrosis Conference in St. Louis.

• Aureus Pharma, of Paris, completed a €3 million (US$3.7 million) private placement, which included two new investors: OTC asset Management and AXA Private Equity, as well as existing investors Bioam and CDC Enterprises-FP Gestion. The funds will be used to extend Aureus Pharma's product portfolio by developing new databases and software and to expand its marketing and sales capabilities globally.

• Cambrex Corp.'s subsidiary Cambrex Bio Science Walkersville Inc., of East Rutherford, N.J., and Epoch Biosciences Inc., of Bothell, Wash., entered a worldwide license whereby Cambrex Bioproducts will incorporate Epoch's MGB Eclipse Probe System technology into its rapid microbial-detection testing products and services. Cambrex received a nonexclusive license to MGB Eclipse technologies and an exclusive license to probe sequences developed for specific patented primer sequences supplied by Cambrex. Epoch will receive an up-front payment for technology access, product sales from shipments of MGB Eclipse probes and primers to Cambrex and royalties. Other financial terms were not disclosed.

• Cell Genesys Inc., of South San Francisco, priced its offering of $110 million in 3.125 percent convertible senior notes due 2011 through a private placement to qualified institutional buyers. The notes will be convertible into common stock at $9.10 per share, representing a conversion rate of about 109.9 shares per $1,000 in notes. The initial conversion price represents a premium of about 30 percent to Cell Genesys' closing stock price of $7 on Oct. 14. The company also granted the initial purchasers a 30-day option for an additional $35 million in notes. Cell Genesys will use the proceeds to repay $95 million in outstanding bank loans, which will eliminate restrictions on its $60 million cash balance.

• Connetics Corp., of Palo Alto, Calif., said UCB Pharma Inc., a subsidiary of UCB Group SA, of Brussels, Belgium, is discontinuing its co-promotion agreement for OLUX and Luxiq to a select segment of primary care physicians effective March 31. As part of the realignment of UCB's commercial focus following its recent acquisition of Celltech plc, of Slough, UK, UCB elected to opt out of the co-promotion agreement.

• Corus Pharma Inc., of Seattle, released positive Phase II trial results for its cystic fibrosis drug Corus 1020 (aztreonam lysinate for inhalation) at the North American Cystic Fibrosis Conference in St. Louis. The study of 105 cystic fibrosis patients with Pseudomonas aeruginosa infections evaluated two dose groups, a 75-mg group and a 225-mg group. Patients took the drug twice daily for two weeks in the double-blinded, placebo-controlled trial. Both dose groups showed greater than or equal to 97 percent reduction from baseline in the amount of Pseudomonas aeruginosa as measured by sputum density. Corus is in discussions with the FDA to move the program into a Phase III trial.

• Enzo Biochem Inc., of Farmingdale, N.Y., said its wholly owned subsidiary Enzo Life Sciences Inc. and Digene Corp., of Gaithersburg, Md., entered a settlement and license agreement, which dismisses with prejudice the litigation involving Enzo's U.S. Patent No. 6,221,581. Enzo will receive minimum payments of $30.5 million and it will grant Digene a nonexclusive royalty-bearing worldwide license for use of the patent and all other patents in the '581 patent family. The platform and the technology involved in the dispute is a format for nucleic acid detection, which has contributed to the success of Digene Hybrid Capture products. The patent expires in 2018.

• GlaxoSmithKline Biologicals, of London, said a study of RTS.S/ASO2A malaria vaccine candidate containing an adjuvant provided by Corixa Corp., of Seattle, showed it protected a significant percentage of children against uncomplicated malaria infection and even severe forms of the disease for at least six months. The double-blind, controlled trial involved 2,022 children in southern Mozambique. The study was published in the Oct. 16, 2004, issue of The Lancet. Further studies are scheduled.

• Icoria Inc., of Research Triangle Park, N.C., signed an agreement with Israel-based Rosetta Genomics Ltd. to commercialize Rosetta's MirChip technology. Through its business unit Paradigm Array Labs, Icoria will become an exclusive provider of MirChip microRNA detection and analysis services. The new service will be launched Oct. 26 at the American Society of Human Genetics conference in Toronto. MicroRNA are small molecules of ribonucleic acid that regulate the building of proteins by interfering with protein assembly in the cell.

• Inspire Pharmaceuticals Inc., of Durham, N.C., presented information from four abstracts at the 18th annual North American Cystic Fibrosis Conference in St. Louis. Three of the abstracts are based on data from a Phase II trial of INS37217 Respiratory in patients with mild to moderate cystic fibrosis. The fourth abstract described the pharmacokinetics of INS37217 Respiratory after inhaled and intravenous administration in healthy volunteers.

• NovaDel Pharma Inc., of Flemington, N.J., reported preliminary findings of a pilot pharmacokinetic study of its lingual spray version of sumatriptan, the active ingredient in London-based GlaxoSmithKline plc's migraine drug, Imitrex. The findings showed that the mean time to reach maximal blood concentrations of the active drug with a 15-mg lingual spray dose was about 20 minutes shorter than with the 50-mg Imitrex tablet, and that the total amount of drug delivered during the first 30 minutes was about 40 percent higher.

• QLT Inc., of Vancouver, British Columbia, and Atrix Laboratories Inc., of Fort Collins, Colo., said QLT's registration statement in connection with their proposed merger has been declared effective by the SEC. QLT specializes in therapies to treat cancer, eye diseases, dermatological and urological conditions. Atrix Laboratories is focused on advanced drug delivery. The estimated $855 merger was originally announced in June. (See BioWorld Today, June 15, 2004.)

• Serologicals Corp., of Atlanta, completed its acquisition of Upstate Group Inc., of Charlottesville, Va., for $102.5 million in cash and about 4.3 million shares of Serologicals' common stock, for a total of $205 million. With the acquisition, Serologicals has increased its critical mass within the research reagent marketplace and positioned itself as a leader in drug screening and validation services, it said. The companies announced the acquisition in September. (See BioWorld Today, Sept. 9, 2004.)

• Serono SA, of Geneva, said the FDA approved Luveris (lutropin alfa for injection) for concomitant use with Gonal-f for the stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound LH deficiency. Women with HH are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support early pregnancy. Luveris is the first and only approved recombinant human form of luteinizing hormone, a naturally occurring fertility hormone.

• Targeted Genetics Corp., of Seattle, presented a safety summary of its ongoing Phase II cystic fibrosis trial of tgAAVCF at the 18th annual North American Cystic Fibrosis Conference in St. Louis. Results from an independent data monitoring committee indicate that planned safety reviews have yielded no safety concerns thus far. In addition, a planned interim analysis in June 2004 resulted in the recommendation to continue the study.

• Trimeris Inc., of Durham, N.C., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said the FDA granted traditional approval to Fuzeon (enfuvirtide), a fusion inhibitor for HIV. The FDA granted accelerated approval to Fuzeon on the basis of 24-week data in March 2003. The traditional approval of Fuzeon was based on results from Phase III trials over 48 weeks which confirmed the durable efficacy and safety of Fuzeon-based regimens.

• TxCell, of Nice, France, raised €10.5 million (US$13 million) in a first round of financing. Five investors, Auriga Partners, AXA Private Equity, Bioam, CDC and SPEF Venture, took part in the deal. They joined existing shareholders Inserm-Transfert and the company's founders and senior management. TxCell has built its technology around the role of the Trl T-regulatory cells in maintaining the balance of the immune system.

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