• Acceleron Pharma Inc., of Cambridge, Mass., said a study in cynomolgus monkeys showed ACE-011 improved bone microarchitecture and increased bone mineral density and bone mechanical strength. Effects on markers of bone formation and bone resorption were similar to those reported in a Phase I trial of ACE-011, a protein therapeutic based on the activin receptor Type IIA. Phase II trials are expected to begin in the fourth quarter. The data were presented at the American Society for Bone and Mineral Research meeting in Honolulu.

• Acusphere Inc., of Watertown, Mass., said it is focusing on partnership discussions, and thus is postponing plans for announcing its new product development program, originally scheduled for late this quarter. The new development plan concerned its microsphere technology. The discussions primarily cover the company's lead product candidate, Imagify (perflubutane polymer microspheres) injectable suspension, a cardiovascular drug for the detection of coronary artery disease.

• Celera Group, a Rockville, Md., business of Applera Corp., and privately held Atria Genetics Inc., of South San Francisco, signed a definitive agreement whereby Celera would acquire substantially all of the assets of Atria for about $33 million in cash. Atria has a line of human leukocyte antigen testing products that are used for identifying potential donors in the matching process for bone marrow transplantation. The transaction is expected to close during the second quarter of Celera's fiscal 2008. Since January 2004, Atria's HLA sequencing-based typing products have been marketed and distributed worldwide by Abbott Molecular through its alliance with Celera, whose revenue proportion from that deal would increase significantly following the acquisition.

• EpiStem Ltd., of Manchester, UK, completed the first year of mucositis efficacy-testing services for potential biodefense drugs, and plans to embark on a drug-screening program over the coming year. Work is being done under a U.S. National Institutes of Health program, Medical Countermeasures against Radiological and Nuclear Threats, to develop treatments for radiation sickness following a nuclear attack.

• GenVec Inc., of Gaithersburg, Md., published preclinical research demonstrating the selective delivery of TNF-alpha to tumors. The work combined a new, targeted adenovector with selective regulation of gene expression. GenVec said it achieved a high degree of antitumor activity and selectivity in animal models of disseminated ovarian cancer. The paper appears in the October issue of the International Journal of Oncology.

• Genzyme Corp., of Cambridge, Mass., and Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA approved a supplemental biologics license application for Campath (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia. Campath initially was approved in 2001 under accelerated approval regulations, and the FDA has determined that the study results submitted in the sBLA fulfill the post-marketing commitment to verify clinical benefit. The new approval means a broader range of patients is now eligible for Campath treatment, regardless of whether the patient has received prior therapy.

• Inhibitex Inc., of Atlanta, said stockholders of both Inhibitex and FermaVir Pharmaceuticals Inc., of New York, approved the companies' previously announced merger agreement. The transaction was expected to become effective later Thursday. The deal called for Inhibitex to issue 11.44 million shares, or 27 percent of the company, to acquire FermaVir, a developer of antiviral agents. Based on the $1.48 closing price of Inhibitex's stock (NASDAQ:INHX) Wednesday, the deal was valued at about $16.9 million, down from the $19 million assigned when the deal was announced in April. Inhibitex's stock fell 6 cents Thursday to close at $1.42. (See BioWorld Today, April 11, 2007.)

• Intellect Neurosciences Inc., of New York, and CHDI Inc., a Los Angeles-based nonprofit organization, entered an agreement under which CHDI will assess Intellect's Oxigon as a potential therapy for Huntington disease. Oxigon is a chemically synthesized form of a naturally occurring molecule believed to have neuroprotectant and antioxidant properties. The company plans to begin Phase II trials of the product in Alzheimer's disease patients in 2008.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its wholly owned subsidiary, Ibis Biosciences Inc., was awarded four new U.S. government contracts totaling up to $4.2 million to advance the detection and identification of microbial threat agents for biodefense applications. Three of the contracts are from the Department of Homeland Security Science and Technology Directorate and total up to approximately $3.3 million. The fourth contract, worth up to $900,000, is from the Defense Threat Reduction Agency, an agency within the Department of Defense. The contracts will fund Ibis' planned development of advanced sample preparation methodologies and validation of applications on the Ibis T5000 for broad biological weapon detection, the advancement of Ibis' microbial forensics applications and the enhancement of Ibis' microbial database.

• Kylin Therapeutics Inc., of West Lafayette, Ind., entered a collaboration with Fort Dodge Animal Health, an Overland Park, Kan., division of Wyeth, to develop RNAi therapeutics for the treatment of cancer. Kylin will use its RNA nanoparticle technology called "pRNA" in the effort. Fort Dodge gets an exclusive license to the pRNA/RNAi therapeutic compounds for the treatment of cancers in companion animals. Kylin retains rights to the therapies for human use. Under terms of the three-year contract, Kylin is entitled to research funding along with potential milestone and royalty payments.

• Lytix Biopharma, of Tromso, Norway, said preclinical studies showed its lead ultra-broad spectrum antimicrobial compound was effective against Gram-positive bacteria. Complete eradication of the test organism was obtained within 24 hours. Additional data showed it had broad efficacy, including Gram-negative Pseudomonas species as well as yeasts and fungi. Lytix expects to submit an investigational new drug application in early 2009.

• Medivir AB, of Stockholm, Sweden, presented data demonstrating MIV-701 significantly reduced osteoclast cell activity via inhibition of the enzyme cathepsin K. Results were from a preclinical osteoporosis model. The product is in Phase I trials. Data were presented at the American Society for Bone and Mineral Research meeting in Honolulu.

• Neurobiological Technologies Inc., of Emeryville, Calif., said its financial statements for the fiscal year ended June 30 contain a going-concern qualification from its independent accounting firm. The company had cash and equivalents of about $8.9 million on June 30. It recently registered to sell $65 million in an underwritten common stock offering, which it expects to close in October.

• Novacea Inc., of South San Francisco, said John Walker was elected CEO, effective immediately. Walker has been chairman of Novacea since July 2006, and was named interim CEO in December 2006. He will maintain his role as chairman.

• NPS Pharmaceuticals Inc., of Parsippany, N.J., said the FDA granted orphan drug designation to Preos (parathyroid hormone [rDNA origin] for injection) for the treatment of hypoparathyroidism, a rare deficiency of parathyroid hormone for which there is no FDA-approved therapy. Encouraging data were seen in that indication in a proof-of-concept study. Preos is in late-stage development, and approved in Europe, for treating osteoporosis.

• Osiris Therapeutics Inc., of Columbia, Md., said Chairman Peter Friedli and certain affiliated entities agreed to extend for one year, through January 2009, lockup agreements that began in October 2006. The parties agreed not to transfer company securities they hold without approval of the company. The extended lockup agreement covers 12.9 million Osiris shares.

• Tibotec Pharmaceuticals Ltd., a, Cork, Ireland, subsidiary of Johnson & Johnson, said the FDA accepted for priority review its new drug application for TMC125 (etravirine), a non-nucleoside reverse transcriptase inhibitor being developed for use in combination HIV therapies. The Prescription Drug User Fee Act goal date for the NDA is Jan. 18.

• Unigene Laboratories Inc., of Fairfield, N.J., and Yale University presented data demonstrating the ability to preserve new bone created using their site-directed bone growth technology. They showed bone formation within the thigh bone of an animal can be maintained for an extended period by treatment with a bone-building agent, such as PTH, followed by a commonly used bone-protective agent, such as a bisphosphonate. Data were presented at the American Society for Bone and Mineral Research meeting in Honolulu.

• Wyeth Pharmaceuticals, of Collegeville, Pa., a division of Madison, N.J.-based Wyeth, said it received a positive opinion from the European Committee for Medicinal Products for Human Use for Torisel (temsirolimus) as a first-line therapy for patients with advanced renal-cell carcinoma who have at least three of six prognostic risk factors. The CHMP's opinion will be forwarded to the European Commission for final approval, anticipated in November. Torisel, an mTOR inhibitor, gained FDA approval in May.

• Xencor Inc., of Monrovia, Calif., selected two humanized monoclonal antibody candidates, XmAb 5574 and XmAb 5483, for investigational new drug-enabling development for the treatment of B-cell malignancies and autoimmune diseases. XmAb 5574 and XmAb 5483 target the antigens CD19 and CD40, respectively. Xencor said it has started preclinical studies of the drug candidates.

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