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[September 29, 2008]

Other News To Note

(BioWorld Today Via Acquire Media NewsEdge) , of Tampa, Fla., received notice that it has fallen below the minimum market capitalization required for continued listing on Nasdaq. The company has until Oct. 22 to regain compliance.

? Ambrilia Biopharma Inc., of Montreal, has decided to sell or license clinical assets C2L and goserelin before year-end, place a hold on its its antiviral R&D activities, and cut staff by a third. The moves are intended to save cash and focus efforts on its oncology program, the company said. The headcount will be cut from 43 to 29 employees, with cuts occurring in the basic research and preclinical team and administrative support functions. In July Ambrilia announced it was advised by Merck & Co., of Whitehouse Station, N.J., that HIV protease inhibitor PPL-100, also known as MK-8122, had been placed on a development hold pending outcome of additional basic science efforts to evaluate other precursors of the drug (prodrugs) and formulation options. Merck is also further exploring development of potential backup compounds, Ambrilia said.



? Astex Therapeutics Ltd., of Cambridge, UK, signed a deal with Cancer Research UK that will allow the non-profit to develop kinase inhibitor AT13148 and potentially initiate clinical trials. Astex will retain rights to the compound, although the nonprofit will receive a royalty interest in exchange for funding part of the development.

? Avant Immunotherapeutics Inc., of Needham, Mass., is changing its name to Celldex Therapeutics Inc. and its Nasdaq ticker symbol from "AVAN" to "CLDX" effective Oct. 1. Privately held Celldex merged with Avant last year, combining the former's antibody pipeline with the latter's public listing and vaccine technologies. Anthony Marucci was appointed president and CEO. (See BioWorld Today, Oct. 23, 2007.)



? Cephalon Inc., of Frazer, Pa., finalized its previously announced $425 million federal settlement related to marketing practices associated with Actiq (oral transmucosal fentanyl citrate), Provigil (modafinil), and GabitRil (tiagabine hydrochloride). The company also will pay $12 million in interest, plead guilty to a misdemeanor and enter a five-year corporate integrity agreement with the Office of the Inspector General. Cephalon also settled its two outstanding state government investigations, in Connecticut and Massachusetts, agreeing to pay a total of $6.85 million. (See BioWorld Today, Nov. 12, 2007.)

? Cepheid, of Sunnyvale, Calif., received FDA clearance to market its Xpert MRSA/SA Skin and Soft Tissue Infection test, a molecular diagnostic for Methicillin-resistant Staphylococcus aureus and Staphylococcus aureus. The test allows detection in an hour rather than two to three days and is expected to facilitate prescriptions of antibiotics.

? Dynavax Technologies Inc., of Berkeley, Calif., received a five-year, $17 million contract from the NIH's National Institute of Allergy and Infectious Diseases to develop vaccine adjuvants for anthrax and other diseases. The adjuvants would be based on Dynavax's Toll-Like Receptor 9 agonist technology, which also is used in the allergy drug Tolamba, which failed in Phase III, and the hepatitis B vaccine Heplisav, which met its Phase III endpoint last month. (See BioWorld Today, May 19, 2008, and Aug. 7, 2008.)

? Elite Pharmaceuticals Inc., of Northvale, N.J., said the FDA accepted the abbreviated new drug application filing for its generic synthetic narcotic analgesic, which Elite will manufacture and receive royalties on through its partnership with generics company ThePharmaNetwork LLC. Funds will be used to advance Elite's controlled-release and abuse-deterrent pain drugs. Shares of Elite (AMEX:ELI) rose 4 cents, or 55.6 percent, to close at 10 cents on Monday.

? Hollis-Eden Pharmaceuticals Inc., of San Diego, presented preclinical data showing that Apoptone (HE3235) reduces tumor size and down-regulates the androgen receptor in models of castration-resistant prostate cancer. The drug also reduced levels of testosterone and dihydrotestosterone, which are necessary for tumor survival. A Phase I/II trial is ongoing. The data were presented at the 13th International Congress on Hormonal Steroids and Hormones and Cancer.

? ImClone Systems Inc., of New York, said the unnamed large pharmaceutical company that offered to acquire the biotech for $70 per share has extended its due diligence period. The suitor was expected either to make a proposal or withdraw by Sunday; ImClone now says the decision will be made by 11:59 p.m., Oct. 1. The offer arose in the wake of New York-based Bristol-Myers Squibb Co.'s $60-per-share bid, which last week was raised to $62-per-share and taken directly to shareholders. (See BioWorld Today, Aug. 1, 2008, Sept. 11, 2008, and Sept. 24, 2008.)

? Limerick NeuroSciences Inc., of South San Francisco, changed its name to Limerick BioPharma. The change reflects the fact that the company's platform technology, which improves bioavailability, has potential beyond neurology indications.

? MedImmune LLC, of Gaithersburg, Md., a wholly owned subsidiary of AstraZeneca plc, licensed its reverse genetics intellectual property to Osaka University's Research Foundation for Microbial Diseases, of Osaka, Japan. The technology generates viruses from segments of DNA and will be used to produce non-live human influenza vaccines. Specific terms were not disclosed, but MedImmune will receive an up-front payment and potential royalties.

? MorphoSys AG, of Martinsried, Germany, extended its three year agreement with Osaka, Japan-based Shionogi & Co. Ltd. for another three years. The agreement provides Shionogi with access to MorphoSys' HuCAL antibody library in exchange for annual user fees. Specific terms were not disclosed.

? Nomad Bioscience GmbH, of Munich, Germany, signed a licensing deal with Icon Genetics GmbH, a wholly owned subsidiary of Leverkusen, Germany-based Bayer AG. The deal provides Nomad with access to Icon's transient expression technology for plant-based manufacturing, which will support Nomad's development of plant-based nanopatterned materials, proteins and enzymes for use in biosimilar proteins and other products. Terms were not disclosed.

? Pharmos Corp., of Iselin, N.J., said it received notice that its bid price has fallen below the minimum required for continued listing on Nasdaq. The company has requested a hearing to appeal its delisting.

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Copyright ? 2008 Thomson BioWorld, All Rights Reserved.

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