• Abbott, of Abbott Park, Ill., said the FDA has approved Simcor, a fixed-dose combination of Niaspan, the firm's extended-release form of niacin, and simvastatin for use along with diet to lower levels of elevated low-density lipoprotein cholesterol and triglycerides and to raise high-density lipoprotein cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not adequate alone. The FDA's approval was based on Simcor safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and Type II hyperlipidemia.

• Ablynx NV, of Ghent, Belgium, said it has received an undisclosed milestone payment from Novartis AG, of Basel, Switzerland, for an exclusive research license under an ongoing research and development collaboration to discover and develop therapeutic Nanobodies targeting numerous diseases that are difficult to address with conventional antibodies and their fragments. Under the agreement, Ablynx receives up-front fees, license fees and funding for research and development. In addition, the firm is eligible for milestone payments and royalties when products achieve commercialization. Novartis has exclusive rights to develop and commercialize the Nanobody products resulting from the partnership. Financial terms were not disclosed.

• AMAG Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted for review the company's new drug application for ferumoxytol in the intravenous treatment of iron deficiency anemia associated with chronic kidney disease. A decision is expected in late October. The filing was based on data from four Phase III trials in which the drug met its endpoints including increasing hemoglobin levels. (See BioWorld Today, July 24, 2007.)

• Biolex Therapeutics Inc., of Pittsboro, N.C., entered a collaboration with Merck Serono, an affiliate of Darmstadt, Germany-based Merck KGaA. Under the deal, Merck will evaluate the ability of Biolex's LEX System to optimize antibody glycosylation structures and production. Terms were not disclosed.

• Bionomics Ltd., of Adelaide, Australia, said it successfully completed preclinical testing on the first of eight proteins licensed to Copenhagen, Denmark-based Genmab A/S, triggering a $1 million milestone payment. Under the agreement, which was executed in February 2006, Genmab acquired the exclusive worldwide rights to eight proteins identified and characterized by Bionomics using its proprietary Angene angiogenesis platform. Bionomics received an up-front fee, and the $1 million is the first in a series of potential milestone payments upon achieving specified preclinical and clinical milestones. Bionomics also will receive milestone payments and royalties on product sales for each product reaching the market.

• Cephalon Inc., of Frazer, Pa., said the FDA accepted for review the company's new drug application for Treanda (bendamustine HCl) in non-Hodgkin's lymphoma patients failing treatment with Rituxan (rituximab, Genentech Inc. and Biogen Idec Inc.). A decision is expected by Oct. 31. Treanda is also under FDA review for first-line treatment of chronic lymphocytic leukemia, with a decision expected March 20. (See BioWorld Today, Jan. 2, 2008.)

• Cleveland BioLabs Inc., of Buffalo, N.Y., reported preclinical data demonstrating that Protectan CBLB502 reduced the side effects associated with the chemotherapeutic drug cisplatinum in mouse studies. The company plans to conduct a Phase I/II trial in the first half of 2008 to evaluate CBLB502's ability to reduce the side effects of radiation and chemotherapy in head and neck cancer. Shares of Cleveland BioLabs (NASDAQ:CBLI) rose 40 cents, or 9.4 percent, to close at $4.66 on Tuesday. Last month, the company's stock fell more than 50 percent after CBLB502 was passed over by the Department of Defense for a radiation exposure contract. (See BioWorld Today, Jan. 7, 2008.)

• Epigenomics AG, of Berlin, signed a nonexclusive licensing deal for its DNA methylation biomarker Septin 9 with Quest Diagnostics Inc., of Madison, N.J. Under the terms, Quest gains rights to use the biomarker to develop a molecular-based laboratory test aimed at helping physicians detect colorectal cancer based on a patient's blood specimen and can act as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests. In return, Epigenomics receives up-front and milestone payments, plus royalties on sales of tests developed using Septin 9.

• Geisinger Health System, of Danville, Pa., and Celera, of Alameda, Calif., a unit of Norwalk, Conn.,-based Applera Corp., have entered into a research collaboration to develop a diagnostic assay for the increased risk of non-alcoholic steatohepatitis, a liver condition that can lead to cirrhosis. The collaboration will evaluate Celera's genetic findings in liver diseases, including the Cirrhosis Risk Score, in the Geisinger bank of more than 600 liver tissue and blood case-control samples donated from patients who have undergone bariatric weight loss surgery. Financial terms of this multiyear collaboration were not disclosed.

• ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., said it finalized a deal with Lovelace Respiratory Research Institute in Albuquerque, N.M., to provide a broad range of product development services pertaining to inhalation and intranasal drug delivery, and associated regulatory affairs support. That agreement is expected to support ImmuneRegen's preparation for an investigational new drug application for Homspera, a potential treatment of radiation sickness, influenza and severe acute respiratory syndrome. No terms were disclosed.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, has released its second candidate into preclinical status, DXL702 (HER2/neu), for the treatment of breast cancer. That follows a recent announcement on InNexus' first preclinical candidate, DXL625 (CD20) for Non-Hodgkin's Lymphoma (NHL) and encouraging preliminary results of tests on DXL625 discovering greater killing potency than the market-leading Rituxan.

• Lipid Sciences Inc., of Pleasanton, Calif., said that Elanco Animal Health, a division of Eli Lilly and Co., of Indianapolis, has exercised its right to "opt in" with a development plan and additional investment on a vaccine study. The study is part of a collaborative research and license agreement between Lipid Sciences and Elanco to research immunological products for animal health applications. Lipid Sciences will receive a technology access fee because of Elanco's decision to move ahead, and might receive payments in the future including milestone payments and royalties from product sales. Financial terms were not disclosed. Lipid also said it was notified by the Nasdaq Capital Market that its stock price has failed to meet the required $1 per share for the past 30 days. The firm has until Aug. 11 to come into compliance.

• Lorus Therapeutics Inc., of Toronto, received notice from the American Stock Exchange that the company is not in compliance with the $6 million stockholder's equity threshold required for continued listing. The notification was triggered by the decline of Lorus' market capitalization to less than $50 million. Lorus will be required to submit to AMEX by March 13 a plan to bring the company into compliance.

• Marshall Edwards Inc., of New Canaan, Conn., said triphendiol (NV-196) was granted orphan drug status in Stage IIb through Stage IV malignant melanoma. That designation provides study design assistance and would guarantee seven years of marketing exclusivity upon approval. Triphendiol, which is expected to start Phase II testing, previously received orphan drug status in pancreatic cancer and in cholangiocarcinoma. A second-generation of phenoxodiol, Marshall Edwards' late-stage compound in platinum-resistant ovarian cancer, triphendiol is believed to work by down-regulating the expression of X-linked inhibitor of apoptosis, which, in turn, activates caspases.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said it plans to conduct a clinical study of MEM 3454, its lead nicotinic alpha-7 partial agonist, on two biomarkers of schizophrenia, P50 sensory gating and mismatch negativity in patients with schizophrenia, as part of its existing collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The biomarker study will enroll about 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy, with the primary endpoint aimed at studying P50 sensory gating and mismatch negativity as potential efficacy biomarkers of nicotinic alpha-7 agonists. Under the terms, Roche will fund that biomarker study, as well as additional formulation and manufacturing activities.

• NanoViricides Inc., of West Haven, Conn., said the nanoviricides drug candidates were found to be highly effective against the deadly Ebola virus in initial cell culture studies by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Animal studies to test the efficacy of the nanoviricides drug candidates against Ebola infection will be undertaken shortly, the company said, citing Army scientists. USAMRIID and NanoViricides entered into a material transfer agreement in October 2007. The resulting joint R&D effort enables USAMRIID scientists to test the efficacy of several NanoViricides antiviral nanomedicines against deadly hemorrhagic fever viruses at the Fort Detrick, Md., BSL4 facilities, the company said.

• NextGen Bioscience Inc., of London, has entered into collaboration negotiations with Warburg Glycomed GmbH, of Erkrath-Unterfeldhaus, Germany, which has developed a new class of drugs, which has shown potent anticancer properties in animal models. Warburg Glycomed has a patent-protected compound that is able to reprogram cancer cells by modulating their aerobic glucose metabolism, which affects their ability to grow.

• Novavax Inc., of Rockville, Md., entered a sale of all of its assets related to Estrasorb, its product indicated for moderate to severe vasomotor symptoms associated with menopause, in North America and a supply agreement for the product with Graceway Pharmaceuticals LLC, of Bristol, Tenn. Under the terms, Novavax will retain the rights to commercialize Estrasorb in other parts of the world. Financial details were not disclosed.

• Oragenics Inc., of Alachua, Fla., was awarded a two-year, $500,000 Phase II Small Business Innovation Research Grant from the National Science Foundation. The funding will support the use of Oragenics' Differentially Protected Orthogonal Lanthionine Technology for large-scale synthesis of the small peptide antibiotic MU1140.

• Perlegen Sciences Inc., of Mountain View, Calif., and the SC Liver Research Consortium are collaborating to discover genetic variations aimed at predicting which hepatitis C patients are most likely to benefit from treatment. Under the terms, the parties will conduct large-scale genetic studies on samples from hundreds of patients with HCV who have been treated, both successfully and unsuccessfully, with interferon-alpha and ribavirin. The cure rate for that regimen is about 50 percent and many patients are dissuaded from treatment because of its side effects, so the goal of Perlegen and SC is to determine which patients, according to genetic signatures, would benefit from interferon-alpha and ribavirin.

• Phytopharm plc, of Godmanchester, UK, received funding from The Michael J. Fox Foundation for Parkinson's Research to support development of Cogane, a nonpeptide, orally bioavailable neurotrophic factor inducer that crosses the blood brain barrier and, in preclinical studies, was able to stimulate the release of neuronal growth factors, increase neurite outgrowth and protect against neuronal degeneration. The $1.2 million grant will be paid over a period of two years and will support further preclinical work to determine the optimal dosing requirements.

• Pinnacle Biologics, of Rockville, Md., said it has entered into an exclusive distribution agreement with MedImmune Inc., of Gaithersburg, Md., for Ethyol (amifostine). The agreement, set to take effect June 1, grants Pinnacle Biologics exclusive Ethyol marketing authorization and certain licenses and distribution rights in Western Europe, Turkey and Israel. Additional terms of the agreement were not disclosed.

• Plexxikon Inc., of Berkeley, Calif., said published data from studies of Plexxikon's targeted cancer compound showed it selectively destroys tumor cells, which contain the B-Raf(V600E) cancer-causing mutation, a defect present in most melanomas and thyroid tumors and a large number of colorectal and other cancers. Data were published in the Proceedings of the National Academy of Sciences by a team of scientists from Plexxikon and the Wistar Institute

• Solvay Pharmaceuticals Inc., of Marietta, Ga., said the FDA has granted fast-track designation to the development program for levodopa-carbidopa intestinal gel for the long-term treatment of motor fluctuations associated with advanced Parkinson's disease. Levodopa-carbidopa is marketed in Europe under the trade name Duodopa.

• Start Licensing Inc., of Austin, Texas, said it plans to legally challenge the use of technology for cloning dogs by RNL Bio Ltd., of South Korea. Start said it controls key patents in Korea that cover animal cloning technology and that RNL is not licensed to use the patents, which are part of a portfolio licensed to Start by Roslin Institute, of Scotland, that are directed to foundational somatic cell nuclear transfer cloning technology used for the cloning of Dolly the sheep.

• Vermillion Inc., of Fremont, Calif., said stockholders approved a 10-for-1 reverse stock split of its common shares. The split is scheduled to become effective at the close of business March 3. Each 10 shares of Vermillion common stock will be converted into one share under the plan, which will simultaneously increase the company's stock price by a factor of 10. The action was taken to bring the company into compliance with a Nasdaq requirement to maintain a minimum bid price of $1.