|
Other News To Note
(BioWorld Today Via Thomson Dialog NewsEdge) , of Los Angeles, said the Korean FDA has granted marketing approval for Abraxane (paclitaxel protein-bound particles for injectable suspension) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. Abraxis granted an exclusive license to Green Cross Corp., of Yongin, Korea, for the commercialization of Abraxane in Korea.
? Aida Pharmaceuticals Inc., of Santa Monica, Calif., announced that its recently acquired research institute in the Jiangsu Province, the Jiangsu Institute of Microbiology Co. Ltd., is developing a new wide-spectrum antibiotic, Wetimicin, in China. Wetimicin is from the newest generation of amino-glycoside family of antibiotics and is being tested for the treatment of various inflammations, such as respiratory infection, urinogenital infection and soft skin tissue infection, as well as infections from trauma and operations. it is currently undergoing Phase I trials in conjunction with the Chinese government's State Food and Drug Administration.
? Amgen Inc., of Thousand Oaks, Calif., said the FDA has moved back the PDUFA date for its priority review of the biologics license application for romiplostim for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura from April 23 to July 23. Amgen presented a risk-management program to the FDA following a March 12 FDA Oncologic Drugs Advisory Committee meeting, and the FDA decided extra time was needed to review it.
? Collegium Pharmaceutical Inc., of Cumberland, R.I., filed a supplemental new drug application with the FDA for the approval of AllerNase (triamcinolone acetonide) Nasal Spray, 50 mcg, an aqueous-based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children 12 and older.
? Cytori Therapeutics, of San Diego, said that it will collaborate with Nagasaki University on a clinical study on the use of cell-enhanced reconstruction in HIV therapy-induced facial atrophy. The study will be funded through a three-year, 58.5 million yen grant (US$600,000), which was awarded to Nagasaki University by the Japanese Ministry of Health, Labor and Welfare.
? EpiCept Corp., of Tarrytown, N.Y., said it has received a letter from Nasdaq stating that the company is not in compliance with the continued listing requirements because the market value of EpiCept's listed securities has fallen below $35 million for 10 consecutive trading days. EpiCept has until May 5 to regain compliance.
? Inovio Biomedical Corp., of San Diego, said the publication of data from preclinical studies demonstrated a 77-fold increase in dendritic cells at the site of administration of a DNA vaccine delivered with electroporation compared to a similar amount of DNA delivered using a DNA injection alone. The paper was published online ahead of print at the Journal of Virology website. That result suggested that electroporation provides a strong adjuvant effect capable of priming the immune system, partially explaining the apparent enhancement that electroporation has provided in enhancing the potency of DNA vaccines in humans, the company said.
? Intra-Cellular Therapies Inc., of New York, announced additional preclinical data from its ongoing development programs for ITI-007, the company's first-in-class dual-5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator, and ITI-722, a low-dose formulation of ITI-007, which are in development for schizophrenia and sleep disorders. Those new data demonstrated ITI-007 has preclinical activity both in vitro and in vivo as an antidepressant. ITI-007 acts as a potent inhibitor of the serotonin transporter.
? Intradigm Corp., of Palo Alto, Calif., said it has licensed intellectual property from the University of Massachusetts Medical School covering next-generation small interfering RNA (siRNA) structural elements. The IP includes the Zamore Design Rules, which are intended to improve the potency and effectiveness of RNAi therapeutics. The agreement was announced at the BIO-Europe Spring 2008 conference in Madrid, Spain, during Intradigm's presentation.
? Kalos Therapeutics, of San Diego, presented additional positive xenograft data today for its Atrial Natriuretic Peptide (ANP) line for the treatment of human cancers at the Experimental Biology 2008 Symposium on Heart Hormones. The data showed the ANP family of peptides has very broad activity in animal models, inhibiting the growth of all of the cancers examined to date: human pancreatic, lung and breast cancers. The new data focused on the most active member of the ANP peptide family that is designated KT-220.
? Lorus Therapeutics Inc., of Toronto, said its subsidiary GeneSense Technologies Inc. has signed an exclusive multinational license agreement with Zor Pharmaceuticals LLC, a subsidiary of Zoticon Bioventures Inc., to further develop and commercialize Virulizin. The initial clinical development will be in advanced pancreatic cancer. GeneSense will be entitled to payments in excess of $10 million upon achievement of various milestones and royalties that vary from 10 percent to 20 percent depending on sales and certain adjustments. In addition, a wholly owned subsidiary of Lorus, Pharma Immune Inc., will receive 25 percent of the initial equity in Zor Pharmaceuticals. Pharma Immune's equity will not be subject to dilution on the first $5 million of financing in Zor. After that, Pharma Immune has a right to participate in any additional financings to maintain its ownership level. Zor Pharmaceuticals will be responsible for the cost of all the clinical development, regulatory submissions and commercialization of Virulizin? in North and South America and Europe. GeneSense will retain rights in all other countries, including Japan, Australia and New Zealand.
? PharmAthene Inc., of Annapolis, Md., said that scientists from the Hebrew University of Jerusalem recently obtained new data suggesting that recombinant butyrylcholinesterase (rBChE), a non-pegylated form of Protexia, may have neuroprotective benefits. In vitro data demonstrated that rBChE effectively blocked the formation of amyloid fibrils, precursors to plaque formation in the brain. Those data were substantiated by transmission electron microscopy studies, which showed that rBChE dramatically suppressed the formation of fibrils, resulting in thinner and less branched filaments than normally would occur in patients with Alzheimer's disease.
? ProMetic Life Sciences Inc., of Montreal, has agreed to acquire the American Red Cross' common stock holding in Pathogen Removal and Diagnostic Technologies Inc. , the joint venture established by ProMetic and ARC in 2002 to develop and commercialize products to diagnose and reduce pathogens in blood, blood derivatives, biopharmaceuticals and other biological products. ARC will receive an ongoing royalty stream from PRDT technology, and ProMetic will raise its ownership position in PRDT to 77 percent by acquiring ARC's 51 percent stake. The remaining 23 percent will continue to be held by the academic co-founders. ARC will continue to hold its preferred stock and maintain representation on the board.
? Targanta Therapeutics Corp., of Cambridge Mass., said the FDA has accepted a new drug application for oritavancin, its lead antibiotic candidate, with a target response date of Dec. 8. Targanta submitted the NDA in February for treating complicated skin and skin structure infections that are caused by Gram-positive strains such as methicillin-resistant Staphylococcus aureus. The drug has been in several studies including two Phase III trials, which both met their primary endpoints.
? VaxGen Inc., of South San Francisco, has initiated a restructuring to cut expenses following the termination of its merger with Raven Biotechnologies Inc., of South San Francisco, including terminating about 75 percent of its remaining staff of 22 persons, including Matthew Pfeffer, the CFO and senior vice president of finance and administration. The company said in the near term its plan of action is to reduce staffing and expenses, continue efforts to sell its anthrax vaccine program and manufacturing facility, deal with lease obligations and reconfigure its board to deal with the future course of the company. The merger with Raven fell through last month due to opposition from VaxGen's investors. (See BioWorld Today, March 31, 2008.)
?
?
Copyright ? 2008 Thomson BioWorld, All Rights Reserved.
[ Back To TMCnet.com's Homepage ]
|
INDUSTRIES
Activate Email 
Find Solutions for Enterprises, SMBs & Service Providers at the INTERNET TELEPHONY Conference and EXPO East, January 20-22, 2010. Miami, FL.
