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Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of Cambridge, Mass., has published data in the journal Oligonucleotides demonstrating robust silencing of an endogenous oligodendrocyte gene with small interfering RNAs when administered by direct delivery to the central nervous system in both rats and nonhuman primates. The data extended the successful delivery of siRNAs in vivo to an additional cell type within the CNS, the company said. ? Antisoma plc, of London, said the FDA approved its tablet formulation of fludarabine phosphate (oral fludarabine) as a second-line treatment for chronic lymphocytic leukemia. Oral fludarabine allows patients to avoid intravenous infusion. Antisoma plans to seek a partner to commercialize the product in the U.S., and said talks are under way and a partner should be selected in early 2009. Fludarabine is an established drug in the treatment of CLL worldwide. Oral and intravenous formulations are in use in Europe, Canada and elsewhere, but in the U.S. only the intravenous formulation has been available. ? ArQule Inc., of Woburn, Mass., said it signed a deal with Daiichi Sankyo Co. Ltd., of Tokyo, for the c-Met inhibitor ARQ 197 that supersedes a previous deal announced last month. As previously reported, ArQule will receive $60 million cash up front for the cancer drug. Separately, ArQule said Basel, Switzerland-based F. Hoffmann-La Roche Ltd. decided not to exercise its option to ARQ 761 under the companies' $267 million E2F pathway deal, which ends Roche's rights to the cancer program as of the end of the year. Additionally, ArQule said its Eg5 inhibitor for cancer, ARQ 621, will begin Phase I trials next year. (See BioWorld Today, April 5, 2004, and Nov. 11, 2008.) ? China Biologic Products Inc., of Taian City, China, said it has further amended its agreement relating to the acquisition of a 90 percent controlling interest in Chongqing Dalin Biologic Technologies Co. Ltd., also of Taian City, which owns 54 percent of the equity interests in Qianfeng Biological Products Co. Ltd., of Guiyang, Guizhou Province, China. China Biologics Products said the acquisition will transform the firm into the largest non-state-owned producer of plasma-based biopharmaceutical products in China. ? Emergent BioSolutions Inc., of Rockville, Md., said the FDA approved its supplemental biologics license application for anthrax vaccine BioThrax, allowing for intramuscular rather than subcutaneous administration across five rather than six total vaccinations. The company may submit an additional sBLA next year to further reduce the number of total vaccinations required if data from a CDC-sponsored trial supports it. ? IDM Pharma Inc., of Irvine, Calif., said the European Committee for Medicinal Products for Human Use formally adopted the positive opinion it issued last month recommending European approval of Mepact (mifamurtide) in nonmetastatic resectable osteosarcoma. Final European Commission approval is expected in the first quarter of 2009. Mifamurtide received an FDA nonapprovable letter last year, and the company plans to resubmit its application for FDA approval early next year. (See BioWorld Today, Aug. 28, 2007.) ? Intercell, of Vienna, Austria, has transferred on an exclusive basis its preclinical Group B Streptococcus (GBS) vaccine program to Novartis AG, of Basel, Switzerland, and has kept and received co-exclusive rights for the development of therapeutic antibodies against Group B Streptococcus and has in-licensed additional rights on GBS antibodies from Novartis. The GBS vaccine program was part of the vaccine portfolio for which Intercell had granted license options to Novartis under a $366 million partnership. That step will trigger a recognition of revenue from the up-front option fee received under this strategic partnership. (See BioWorld Today, July 5, 2007.) ? Kinetic Concepts Inc., of San Antonio, and Wake Forest University Health Sciences have filed a patent infringement suit against Convatec Inc., of Skillman, N.J., Boehringer Wound Systems LLC and its affiliate, Boehringer Technologies LP, of Norristown, Pa., in Federal District Court in the Middle District of North Carolina. The suit is over the commercialization of the Engenex negative pressure wound therapy system. ? NeurogesX Inc., of San Mateo, Calif., said the FDA accepted its new drug application for NGX-4010 in management of pain due to post-herpetic neuralgia. A decision is expected in late 2009. The company proposed to market the drug, a capsaicin patch, under the brand name Qutenza. (See BioWorld Today, Oct. 23, 2008.) ? NitroMed Inc., of Lexington, Mass., said its directors and advisors are re-evaluating an offer from Deerfield Management to buy the firm for 50 cents per share in light of the new understanding that Deerfield's offer is in lieu of both the proposed reverse merger with Cambridge, Mass.-based Archemix Corp. and the proposed sale of heart failure drug BilDil to JHP Pharmaceuticals LLC, of Parsippany, N.J. Shares of NitroMed (NASDAQ:NTMD) lost 2 cents, to close at 32 cents on Friday. (See BioWorld Today, Dec. 8, 2008.) ? Novocell Inc., of San Diego, said it entered into a nonexclusive drug discovery collaboration that gives Pfizer Inc., of New York, access to its proprietary pancreatic progenitor cells derived from human embryonic stem (hES) cells. Under terms of the agreement, Novocell will receive an undisclosed up-front payment and could gain additional payments if certain technical milestones are achieved. In addition, the firm could bank additional funds from the deal related to sales of any successful products. Pfizer has an option to extend the two-year research agreement under the deal. No other financial details were disclosed. ? S*BIO Pte Ltd., of Singapore, said it signed a collaboration agreement with Tan Tock Seng Hospital in Singapore to evaluate the effects of its JAK2 inhibitor, SB1518, on biological samples from patients with myeloproliferative neoplasms. Under the partnership, S*BIO scientists will work with the hospital's investigators to evaluate the potential therapeutic effects of SB1518 on diseased blood cells isolated from patients with MPN, and to validate the utility of novel biomarker assays with those patient samples. The cellular response to drug treatment will be monitored in terms of general viability, specific apoptotic response, specific biomarker changes and JAK2 mutational status. ? SkyePharma plc, of London, said it has ceased discussions about commercializing the approved formoterol Certihaler in the U.S. next year, given the recommendations made by FDA advisers at a joint meeting of the Pulmonary-Allergy Drugs and Drug Safety and Risk Management Advisory Committees on Dec. 11 that the risks of long-acting beta agonists administered alone outweigh the drugs' benefits. SkyePharma said that cessation of production for formoterol Certihaler will result in asset write downs and a related noncash charge estimated at ?7 million (US$9.75 million) to ?8 million, which the firm said is likely to be charged in its 2008 results. ? Sun Pharmaceutical Industries Ltd., of Mumbai, India, said its subsidiary, Alkaloida Chemical Co. Exclusive Group Ltd., has extended the expiration date of the tender offer for the purchase of all outstanding ordinary shares of Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., to Jan. 9. The tender offer was extended to comply with a continuing order issued by the Supreme Court of Israel temporarily prohibiting the closing of the offer until the court issues a decision on the appeal of the litigation commenced against Alkaloida and its affiliates by Taro and certain directors about the applicability of the special tender offer rules under the Israeli Companies Law. The Tel-Aviv District Court previously ruled in favor of Sun Pharma that a special tender offer was not required. ? Viralytics Ltd., of Sydney, Australia, said its researchers and those from the University of Newcastle have demonstrated proof of concept with the destruction of human brain tumors by Cavatak, Viralytics' lead product. The preclinical collaboration is investigating the oncolytic activity of Cavatak in mouse models of human brain cancer. Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |