• Amgen Inc., of Thousand Oaks, Calif., submitted a supplemental biologics license application to the FDA to further expand the use of Enbrel (etanercept) to inhibit the progression of structural damage in psoriatic arthritis patients. The sBLA is based on the results of a 12-month, double-blind, placebo-controlled trial. Those results will be presented in a plenary session at the 66th annual American College of Rheumatology Scientific meeting in New Orleans. Also under review is an sBLA filed by Amgen for the use of Enbrel to improve physical function in patients with rheumatoid arthritis. Amgen last week also submitted an sBLA to the FDA for use of the drug Kineret to inhibit progression of structural damage in adults with moderate to severe rheumatoid arthritis. (See BioWorld Today, Oct. 24, 2002.)

• Bio-Rad Laboratories Inc., of Hercules, Calif., broke ground on a 140,000-square-foot facility that will accompany three existing buildings. Designed to support company growth in functional genomics and proteomics, the facility is expected to be completed next fall.

• Centocor Inc., of Malvern, Pa., expanded its research and development platform to center on the discovery and application of therapies to treat immune-mediated inflammatory disorders. Centocor said the platform builds upon knowledge of Remicade (infliximab), a tumor necrosis factor alpha therapy approved to treat both rheumatoid arthritis and Crohn's disease. Remicade data from studies in a variety of immune-mediated inflammatory disorders including psoriatic arthritis, ankylosing spondylitis and early rheumatoid arthritis were to be presented at the American College of Rheumatology meeting in New Orleans over the weekend.

• Cytogen Corp., of Princeton, N.J., implemented a reverse 1-for-10 split of its issued, outstanding and authorized shares of common stock, saying its common stock would begin trading on Nasdaq on a post-reverse-split basis today under the symbol CYTOB, and 20 days later under the symbol CYTO. It will have about 8.8 million shares outstanding after the reverse split.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., presented at this weekend's Infectious Diseases Society of America meeting in Chicago data on its investigational antibiotic, Cidecin (daptomycin for injection). Analysis of a Phase III safety and efficacy study indicated that subjects receiving daptomycin required fewer concomitant medications due to adverse events than those receiving comparator agents, and that daptomycin-treated subjects experienced fewer hypersensitivity reactions requiring discontinuation of therapy (p=0.06) than those in the comparator arm. Also, 47 percent of vancomycin-treated subjects required dosage adjustments vs. 15 percent of subjects receiving daptomycin (p<0.0001). A separate study showed daptomycin caused a dose-dependent significant reduction of bacterial counts. At a five-hour point, daptomycin achieved a greater than 99 percent reduction in methicillin-resistant and methicillin-susceptible Staphylococcus aureus, as well as vancomycin-resistant Enterococcus faecalis bacterial counts. In vitro data from another study indicated that daptomycin showed in vitro synergy with rifampin at clinically achievable concentrations for 15 of 19 (79 percent) in VRE strains both resistant and susceptible to rifampin.

• Endovasc Ltd., of Montgomery, Texas, said it plans to file an application to become listed on the American Stock Exchange by the end of the first calendar quarter of 2003. The company said due to its recent $2.5 million licensing agreement and collaboration it believes it meets many of the quantitative and qualitative requirements for an Amex listing. Endovasc said it has a market capitalization of about $30 million. Endovasc is focused on drug delivery and cardiovascular disease.

• Entropia Inc., of San Diego, and the Cambridge Crystallographic Data Centre in Cambridge, UK, entered a collaboration to accelerate virtual screening in the pharmaceutical industry. Entropia and CCDC are working to optimize PC grid computing for virtual screening. That will allow researchers to cost-effectively accelerate the analysis of large compound databases when using Entropia's DCGrid, the company said.

• GeneMachines Inc., of San Carlos, Calif., launched the next generation of PolyPlex oligonucleotide synthesizer, which offers capabilities of synthesizing up to one micromole scale using cartridges and accommodating a variety of chemistries with eight amidite reagent positions, the company said. GeneMachines offer a product line of microarraying, DNA synthesis and automated DNA sample preparation instruments, in addition to associated reagents and consumables.

• Genome Therapeutics Corp.'s drug Ramoplanin was the subject of a study presented at this weekend's Infectious Diseases Society of America meeting in Chicago. Data show the drug demonstrates potent in vitro bactericidal activity against vancomycin-resistant enterococci (VRE), including linezolid- and quinupristin/dalfopristin-resistant strains of the bacteria, both recently approved to treat VRE bloodstream infections. The study documented Ramoplanin's ability to kill bacteria, specifically linezolid- and quinupristin/dalfopristin-resistant VRE, by inhibiting an essential component of the bacterial cell wall. Data further demonstrated that Ramoplanin inhibited the bacteria at very low concentrations (minimum inhibitory concentrations: 0.125-0.25 ug/ml). The Waltham, Mass.-based firm's Ramoplanin is in Phase III testing to prevent bloodstream infections caused by VRE.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported an update on the status of its collaboration with Aeson Therapeutics Inc., of Tucson, Ariz. Hollis-Eden entered a relationship with Aeson in October 2000, with Hollis-Eden acquiring equity in Aeson that included about 25 percent of the outstanding shares of Aeson and obtaining an option to purchase the remainder of the company at a predetermined price. Aeson has been developing a compound for cardiovascular disease known as fluasterone. However, Hollis-Eden said it will pursue nearer-term commercial opportunities and will not exercise its purchase option for the remainder of Aeson.

• Neurochem Inc., of Saint-Laurent, Quebec, said its investigational new drug application for Cerebril, its lead candidate for the prevention of recurrent hemorrhagic stroke due to cerebral amyloid angiopathy, was cleared by the FDA. The application was filed Sept. 23. Neurochem may now initiate a Phase II trial for patients with the disease.

• Noven Pharmaceuticals Inc., of Miami, reported positive Phase III trial results for its once-daily transdermal methylphenidate system. The double-blind, placebo-controlled, multicenter study was conducted to assess the efficacy and safety of Noven's developmental methylphenidate patch for attention-deficit hyperactivity disorder, which Noven intends to market under the trade name MethylPatch. The four-week study involved 212 patients ages 6 to 12 meeting the DSM-IV criteria for ADHD. It showed that MethylPatch was significantly superior to placebo on all primary and secondary efficacy measures and resulted in significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention (p< 0.0001).

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., received from the FDA an approvable letter for its new drug application for rifaximin, an investigational drug under review for the treatment of travelers' diarrhea. The NDA was accepted for filing on Feb. 24 and was assigned a user fee goal date of Oct. 25.

• SemBioSys Genetics Inc., of Calgary, Alberta, received the Alberta Science and Technology Award for Innovation in Industrial Research Prize. The award recognizes SemBioSys' efforts in changing the way proteins are made. It is based on a technology proposal involving Rodrigo Marins, a graduate student in plant molecular biology who has been working in the laboratory of SemBioSys' founder and CEO.

• SignalGene Inc., of Montreal, said that the material transfer and option agreement executed in June with Novuspharma SpA, of Milan, Italy, expired. The agreement was for a time-limited option to negotiate the exclusive rights to license SignalGene's SG292 compound for oncology indications. SignalGene said that Novuspharma conducted in vivo studies of SG292 and found that it demonstrated significant anticancer activity and was not toxic at high doses in mice. However, Novuspharma concluded that it did not have sufficient information to pursue development.