• Advanced Life Sciences Holdings Inc., of Chicago, said its ketolide antibiotic Restanza (cethromycin) achieved 100 percent protection against a lethal inhaled dose of anthrax in an animal study. The company plans to complete an additional study with the National Institutes of Health and submit the drug for approval under the FDA's animal efficacy rule. Restanza is already under FDA review for mild to moderate community-acquired bacterial pneumonia, but earlier this month an FDA advisory committee voted against the drug's efficacy. (See BioWorld Today, June 3, 2009.)

• Amgen Inc., of Thousand Oaks, Calif., said the FDA has scheduled a Reproductive Health Drugs Advisory Committee meeting for Aug. 13 to review data supporting the biologics license application for denosumab, a RANK ligand inhibitor, in the prevention and treatment of postmenopausal osteoporosis and prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. Amgen submitted the BLA in February. (See BioWorld Today, Feb. 24, 2009.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said its marketing partner, PharmaSwiss SA, of Ljubljana, Slovenia, submitted a new drug application in Israel for Elestrin (estradiol gel) in the treatment of moderate to severe hot flashes associated with menopause. The product is approved by the FDA and marketed in the U.S. by Azur Pharma Ltd., of Dublin, Ireland.

• Biovista Inc., of Charlottesville, Va., said that BVA-601, its small-molecule drug targeting epilepsy, has shown positive results in the Kainic acid murine model of temporal lobe epilepsy. BVA-601, an existing drug that Biovista repositioned in epilepsy, exhibits both anti-epileptic and neuroprotective activity. In the preclinical trial, BVA-601 induced a statistically significant decrease of epileptic activity in mice pre-treated with Kainic acid.

• Compugen Ltd., of Tel Aviv, Israel, said its CGEN-25007 peptide has shown positive therapeutic effects in an animal model of inflammatory bowel disease. CGEN-25007 is a novel peptide antagonist of gp96 with potent anti-inflammatory activity. It initially was discovered using Compugen's disease-associated conformation blockers discovery system, designed to find peptides that block proteins from achieving certain disease-associated conformations. Compugen's stock (NASDAQ:CGEN) gained 47 cents, or 39 percent Tuesday, to close at $1.68.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., reported preclinical results showing that Ampakine CX717 demonstrated the rescue of fentanyl-induced respiratory depression and sleep apnea in rats and showed equal efficacy with the opioid antagonist Naloxone. CX717 did not interfere with the opiates' pain-killing action. Data were published in the June 2009 issue of Anesthesiology.

• Epeius Biotechnologies Inc., of San Marino, Calif., reported results from two studies using Rexin-G, a tumor-targeted cancer drug designed to attack metastatic cancers, which showed the drug's efficacy as a single agent. Data were published in the June 16, 2009, issue of Molecular Therapy.

• Exosome Diagnostics Inc., of New York, and DxS Ltd., of Manchester, UK, will collaborate on the development of blood-based companion diagnostics for key cancer gene mutations, such as KRAS, BRAF and EGFR. The collaboration will use DxS' Scorpions real-time PCR Mutation Test Kits in conjunction with ExosomeDX's xOS technology, which harvests high-quality nucleic acids from blood exosomes. The collaboration will focus initially on developing blood-based measurements of KRAS, BRAF, EGFR and other key mutations for predicting patient response to targeted therapies. Financial terms were not disclosed.

• IDM Pharma Inc., of Irvine, Calif., had 86.4 percent of its shares tendered under the previously announced acquisition by Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Takeda plans to acquire the remaining shares as well, paying about $66.7 million in total for IDM. (See BioWorld Today, May 19, 2009.)

• IntelGenx Corp., of Saint Laurent, Quebec, said the new drug application filing for its antidepressant CPI-300 has been accepted by the FDA for standard review. IntelGenx expects the FDA will complete its review or otherwise respond by Feb. 6, 2010. CPI-300 was formulated using IntelGenx's proprietary controlled-release technology. It contains a new strength of a widely prescribed antidepressant, and it will be indicated for the treatment of major depressive disorder.

• Lorus Therapeutics Inc., of Toronto, reached a deal to buy back C$15 million (US$9.7 million) in secured convertible debentures from Erin Mills Investment Corp. for C$3.3 million, and gave Mills the rights to Virulizin, an immunotherapeutic agent for cancer, from a 2008 licensing agreement with Zor Pharmaceuticals Inc., a subsidiary of Zoticon Bioventures Inc. Under the Mills deal, Lorus gets half of the royalties received under the Zor agreement, and has a license for the use of Virulizin in animals.

• MDRNA Inc., of Bothell, Wash., was notified by Nasdaq that it has regained full compliance with all requirements including having a minimum market value of listed securities of $50 million.

• MediGene AG, of Frankfurt, Germany, entered into a marketing partnership with Juste SAQF, of Madrid, Spain, for the commercialization of Veregen ointment in Spain and Portugal. Under the partnership, Juste will promote and distribute the drug for the treatment of genital warts. Depending on specified milestones and sales targets achieved, MediGene is entitled to successive payments totaling up to €2.55 million (US$3.58 million). MediGene will supply Juste with the finished product and will receive royalties on the sales revenue for Veregen.

• Prolong Pharmaceuticals Inc., of Monmouth Junction, N.J., said it completed the initial phase of its grant award from the National Heart, Lung, Blood Institute to produce pegylated hemoglobin. That first phase involved establishing manufacturing procedures. In the second phase, Prolong will ramp up its manufacturing capability to full GMP commercial levels. The project is intended to help standardize blood substitute research for investigations into areas such as anemia, aftershock trauma, combat care and other potential applications.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., is collaborating with the U.S. Army Medical Research Institute of Chemical Defense to evaluate the ability of RGN-259 eye drops to prevent or reduce damage to the eye caused by exposure to chemical agents. The project will consist of a series of research experiments over the next 12 months with the compound, which is being commercially developed by RegeneRx and is in Phase II trials. Financial terms were not disclosed.

• Trubion Pharmaceuticals Inc., of Seattle, said Wyeth, of Madison, N.J., has exercised an option under the terms of its collaboration agreement with Trubion to extend the research period for an additional one-year period through December 22, 2010. Under the terms of the research period extension, Wyeth's obligations to Trubion include collaboration research funding commitments of about $3.3 million in exchange for committed research services. In December 2005, Trubion entered into a collaboration agreement with Wyeth for the development and worldwide commercialization of Trubion's TRU-015 and other therapeutics.