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Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of Los Angeles, and partner Specialised Therapeutics Australia Pty Ltd., of Melbourne, Australia, received approval from the Australian Therapeutic Goods Administration to market Abraxane (paclitaxel protein-bound particles for injectable suspension) for the second-line treatment of metastatic breast cancer. Abraxane is approved for breast cancer in 36 countries, including the U.S., where it is co-marketed with partner AstraZeneca plc. ? Celsion Corp., of Columbia, Md., signed a joint research agreement with Royal Philips Electronics, of Amsterdam, the Netherlands, to develop a cancer treatment that combines Celsion's liposomal encapsulation of doxorubicin with Philips' investigational magnetic resonance imaging-guided high intensity-focused ultrasound system. The combination treatment would be designed to target and treat otherwise inaccessible tumors. Terms were not disclosed. Shares of Celsion (NASDAQ:CLSN) rose 49 cents, or 20.8 percent, to close at $2.85 on Thursday. ? China Biologic Products Inc., of Taian City, China, said its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., acquired 35 percent of the equity interest in Xi'anHuitian Blood Products Co. Ltd., of Xi'an, China, for $6.44 million. The transaction is expected to be completed within two months. The deal will increase China Biologic's plasma supply and additional production capacity and allows the firm to expand into the Shaanxi Province. The firm said the acquisition makes China Biologic the largest nonstate owned producer of plasma-based products in China. ? DeCode Genetics, of Reykjavik, Iceland, said it is reviewing its long-term business strategy to optimize the value of its assets in intellectual property portfolios in both therapeutics and DNA-based diagnostics. The goal is to sharpen the focus of its business by selling noncore assets, securing partnerships and using the resources generated to develop its core business. The company said it has engaged the Stanford Group Co. to assist. DeCode also said it has elected to use a 30-day grace period for the scheduled Oct. 15 interest payment on its outstanding 3.5 percent senior convertible notes due 2011. ? Eisai Corp. of North America, of Woodcliff Lake, N.J., said the FDA approved a supplemental biologics license application for Ontak (denileukin diftitox) solution for intravenous injection in patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin 2 receptor. Eisai acquired Ontak from San Diego-based Ligand Pharmaceuticals Inc. in 2006. ? Exelixis Inc., of South San Francisco, said it has submitted a comprehensive data report for investigational new drug candidate XL413, a selective inhibitor of Cdc7, to Bristol-Myers Squibb Co., of Princeton, N.J., which has 30 days to review the data package and determine if it will select the compound for clinical development and commercialization. If BMS selects XL413, a small-molecule inhibitor of the serine-threonine kinase Cdc7, Exelixis will be entitled to a $20 million milestone payment under the 2007 collaboration to discover, develop and commercialize novel targeted therapies for the treatment of cancer. Under the terms of the agreement, Exelixis is fully responsible for the identification and preclinical development of small-molecule drug candidates directed against mutually selected targets. ? The FDA unveiled labeling changes to Raptiva (efalizumab), including a boxed warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML). The FDA also is requiring the submission of a risk evaluation and mitigation strategy (REMS), which will include a medication guide for patients and a timetable for assessment of the REMS. Earlier this month, Genentech Inc., of South San Francisco, issued an alert about a case of a rare life-threatening brain infection in an elderly patient treated with Raptiva, making it the third therapy to be linked to the disease. The FDA said Thursday its Office of Surveillance and Epidemiology has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva. (See BioWorld Today, Oct. 6, 2008.) ? Genzyme Corp., of Cambridge, Mass., said long-term, five-year outcomes of a study of kidney transplant patients undergoing induction therapy showed that its Thymoglobulin (antithymocyte globulin [rabbit]) resulted in less incidence of acute rejection compared to Simulect (basiliximab, Novartis AG). Data also showed that Thymoglobulin resulted in less need for antibody treatment of acute rejection and showed a lower composite endpoint for acute rejection, graft loss and death vs. basiliximab. Data were published in the New England Journal of Medicine. ? Immutep SA, of Orsay, France, said the FDA has approved the investigational new drug application for a Phase I study of IMP321, a first-in-class immunopotentiator that agonizes MHC class II molecules thereby stimulating antigen-presenting cells, such as dendritic cells and monocytes, leading to markedly improved cytotoxic CD8 T-cell responses against tumors in patients with metastatic kidney or breast cancer. The open-label, two-arm, dose-escalation Phase I trial will assess the safety and tolerability of IMP321 in advanced pancreatic cancer. More than 500 subcutaneous injections have been administered to date at dosages up to 30 mg, the firm said. ? InterMune Inc., of Brisbane, Calif., said Japan regulators approved the new drug application submitted by Shionogi & Co. Ltd., of Osaka, Japan, to market pirfenidone in idiopathic pulmonary fibrosis. Shionogi holds rights to the drug in Japan, Taiwan and South Korea. InterMune also reported an update from its Phase III program of pirfenidone, in which more than 97 percent of transplant-free surviving patients have completed their week 72 visit at which the primary endpoint is assessed. The firm expects to report top-line data in January or February of 2009. ? MedImmune, of Gaithersburg, Md., said it licensed its reverse genetics intellectual property to Omnivest, a Hungarian research and manufacturing company, to support the development and construction of new vaccine strains to produce non-live human influenza vaccines. Under the terms MedImmune will receive an up-front payment and has the potential to receive royalties on certain vaccine stockpiles or sales of other influenza products developed using the technology. ? Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., said it completed its corporate name change to Adeona Pharmaceuticals Inc. and is now trading on the American Stock Exchange under the ticker "AEN." The company focuses on developing disease-modifying treatments for autoimmune and central nervous system diseases. ? Valeant Pharmaceuticals International, of Aliso Viejo, Calif., completed its acquisition of Coria Laboratories Ltd., of Fort Worth, Texas, in a deal valued at $95 million. The acquisition is expected to expand Valeant's dermatology franchise. ? VistaGen Therapeutics Inc., of South San Francisco, said researchers from the company, along with Toronto's McEwen Centre for Regenerative Medicine and the Mount Sinai School of Medicine, successfully identified key biochemical pathways involved in directing embryonic stem cells to become heart cells. Research was published in the online edition of Nature Biotechnology. ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |