• Aerogen Inc., of Mountain View, Calif., received a letter from the Nasdaq Stock Market that the company's common stock would be delisted from the SmallCap Market on Wednesday. The company does not intend to further appeal the decision. Its shares will be listed on the Over-the-Counter Bulletin Board under the same symbol, "AEGN."

• Bavarian Nordic A/S, of Copenhagen, Denmark, initiated a Phase II trial to investigate the safety and immunogenicity of the smallpox vaccine Imvamune in HIV-infected patients. It involves 150 volunteers who will be treated at five U.S. sites. It is the company's second clinical study of Imvamune in HIV patients.

• Berlex Inc., of Montville, N.J., and its parent company, Schering AG, of Berlin, said that more than 2,100 patients with relapsing-remitting multiple sclerosis have been enrolled in the BEYOND (Betaseron Efficacy Yielding Outcomes of a New Dose) study, thereby reaching the study's enrollment goal.

• BioDelivery Sciences International Inc., of Morrisville, N.C., received written notification from the FDA that its new drug application for Emezine was accepted for review. BDSI previously reported that it filed the NDA in late April. Emezine is a formulation of prochlorperazine, an approved agent for nausea and vomiting.

• Cepheid Inc., of Sunnyvale, Calif., said UK-based DxS Ltd. agreed to license its Scorpions technology to Cepheid for use in all worldwide markets excluding clinical diagnostics, wine production and detection of chemicals used in agriculture. The first commercial products expected to use the Scorpions probes for Cepheid will be in the recreational water-testing area.

• Cobalis Corp., of Irvine, Calif., said a preliminary analysis of data from a 715-patient Phase III trial evaluating its allergy drug PreHistin showed that pre-seasonal treatment with the product appeared to reduce allergy symptoms. Patients with mild to moderately severe allergic rhinitis who received the sublingual cyanocobalamin lozenges showed definite reductions in allergy symptoms compared to patients receiving placebo. Data also showed that the treatment arm receiving PreHistin throughout the entire six-week trial had the greatest reduction in symptoms. The company expects full results to be reported in four to six weeks.

• DOR BioPharma Inc., of Miami, and a subsidiary of Cambrex Corp., of East Rutherford, N.J., achieved, ahead of schedule, the first milestone of fermentation and downstream process development in their development and manufacturing agreement for RiVax, DOR's ricin toxin vaccine. DOR and Cambrex entered an agreement in January under which Cambrex would provide process development and cGMP production services for the development and manufacture of clinical quantities of RiVax.

• Genentech Inc., of South San Francisco, and the FDA revised the adverse reaction warnings for the psoriasis drug Raptiva (efalilzumab) to include risks of immune-mediated hemolytic anemia. The company reported that two cases were observed in clinical trials of Raptiva. The news, posted on the FDA's website Wednesday, also includes warnings regarding post-marketing reports of thrombocytopenia and serious infections, such as bacterial sepsis.

• iDiverse, of Del Mar, Calif., signed an exclusive license agreement with the University of Nebraska at Lincoln to commercialize UNL's transgenic plant technology, which provides plants with resistance to a broad spectrum of diseases and environmental stresses. iDiverse is dedicated to developing such plants with the addition of only one gene.

• InterMune Inc., of Brisbane, Calif., and Array BioPharma Inc., of Boulder, Colo., said they are extending and expanding their collaboration to discover and develop small-molecule inhibitors of the hepatitis C virus NS3/4 protease. The program, which began in 2002, has produced several candidates that InterMune is moving into investigational new drug application-enabling studies. Under the terms, InterMune will fund drug discovery, preclinical and process development at Array, as well as maintain responsibility for clinical development and commercialization. Array would receive milestone payments, as well as royalties from any product sales.

• Kalypsys Inc., of San Diego, appointed August Watanabe nonexecutive chairman. He first was appointed to the board in March. Watanabe served as a senior executive at Eli Lilly and Co. for 13 years beginning in 1990. Kalypsys is a small-molecule drug discovery and development company.

• Ligand Pharmaceuticals Inc., of San Diego, received a letter from the FDA requesting that the company change the label of its sustained-release opioid product, Avinza (once daily morphine sulfate extended-release capsules), to intensify warnings about consuming alcohol while taking the drug. Ligand said it is working with the FDA to determine the specific changes, and might complete additional in vivo translational pharmacokinetic studies to assess which changes should be made. Avinza was approved in 2002 for chronic moderate to severe pain in patients who require continuous opioid therapy for an extended period of time.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., completed enrollment for its European-based NicVax Phase II dose-ranging study in smokers to prevent and treat nicotine addiction. The study is designed to evaluate NicVax's safety, antibody response to nicotine, and measure smoking cessation/nicotine dependency. Preliminary results should be announced by the end of this year, when the company then could start a European Phase III pivotal trial.

• Neose Technologies Inc., of Horsham, Pa., said the FDA advised the company that it has placed the proposed Phase I trial for NE-180 on hold. Neose submitted the investigational new drug application in June for NE-180, a long-acting, GlycoPEGylated erythropoietin to treat chemotherapy-induced anemia. The FDA informed the company that it requires additional manufacturing and preclinical information in order to complete the review of the IND. Neose previously had expected to start the Phase I trial in the third quarter. Neose's stock (NASDAQ:NTEC) fell 81 cents Wednesday, or 19.5 percent, to close $3.35.

• Ortec International Inc., of New York, received notification from the FDA that it approved Ortec's clinical study design and protocol and authorized Ortec to initiate the confirmatory study to support the safety and effectiveness results contained in Ortec's pre-market approval application. Ortec may enroll up to 60 patients in a study of Orcel in the treatment of venous ulcers.

• Osteologix Inc., of San Francisco, completed patient enrollment in the first Phase I trial of NBS-101 to treat osteoporosis. The compound is being studied as an improved formulation of strontium ranelate, which recently was approved in Europe.

• Rejuvenon Corp., of Bridgewater, N.J., initiated a Phase I study of its second investigational drug, RC-8800, a small molecule designed to act on the vitamin D (calcitriol) metabolic pathway to treat prostate and other cancers. The company also moved its other investigational drug, RC-1291, into Phase II trials in cancer patients with cachexia.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said results of preclinical studies evaluating its drug candidates, SP-08 and derivatives, as a possible approach to treat Alzheimer's disease were published in the journal NEUROPharmacology. The company said early data of SP-08 showed promise in targeting the build-up of amyloid protein in the brain, which causes the progression of Alzheimer's disease.

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