• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said it received an approvable letter from the FDA pertaining to its new drug application for CIP-Tramadol ER, a once-daily formulation of tramadol. The approvable letter included a request for an additional efficacy trial. The FDA also called for resolution of certain issues relating to chemistry, manufacturing and controls. The NDA was submitted in June. Cipher said it plans to meet with the FDA to clarify the issues before determining the path forward. Cipher's stock (TSX:DND) fell C$1.12 Friday, or 27.7 percent, to close at C$2.93.
• Expression Pathology Inc., of Gaithersburg, Md., and Oridis Biomed GmbH, of Graz, Austria, formed an alliance to offer tissue microproteomic capabilities for protein biomarker discovery and validation. The relationship combines Expression Pathology's Liquid Tissue and Director technologies, which enable mass spectrometry-based discovery and measurement of protein biomarkers, with Oridis' Tissomics platform for high-throughput analysis of patient tissue and its access to tissue samples. The goal is to provide capabilities to identify and measure protein biomarkers that relate to specific disease progression, drug response and toxicity. Both companies will offer collaborative research capabilities and services to clients.
• ISTA Pharmaceuticals Inc., of Irvine, Calif., received a not-approvable letter from the FDA relating to its new drug application for T-Pred (prednisolone acetate 1% and tobramycin 0.3% ophthalmic suspension). T-Pred is being developed as a topical steroid to treat inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of them exists. The FDA said Phase III trials failed to demonstrate bioequivalence in certain areas. ISTA, which said it believed the data were sufficient to warrant approval, said it intend to request a meeting with the agency to determine what actions it must take to gain approval. ISTA's stock (NASDAQ:ISTA) fell $2.82 Friday, or 29.3 percent, to close at $6.80.
• Lux Biosciences Inc., of Jersey City, N.J., and collaborators presented preclinical data demonstrating the ability of subcutaneous injections of LX211 to prevent and reverse experimental autoimmune uveoretinitis in rats. LX211 is a next-generation calcineurin inhibitor to which Lux licensed rights in ophthalmic indications from Isotechnika Inc., of Edmonton, Alberta. Data were presented at the Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, Fla.
• Pasteuria Bioscience, of Alachua, Fla., completed a $5.3 million closing of a Series B financing round led by LSP BioVentures, which joined Series A investors Advantage Capital and Gordon River Capital. Pasteuria, founded in 2003, is an agricultural biotech company focusing on the need for reducing plant parasitic nematodes in agricultural and turf markets. It said it has developed a process for the industrial production of Pasteuria bacteria, a naturally occurring predator of plant-parasitic nematodes.
• Sangamo BioSciences Inc., of Richmond, Calif., presented preclinical data from its ZFP Therapeutic program in nerve regeneration. The data generated, in a model of spinal cord injury, demonstrated that treatment of the spinal cord at the time of injury with a VEGF ZFP TF had a statistically significant effect on recovery of hind-limb function as well as a number of other measures of nerve integrity and health. The product is a zinc finger DNA-binding protein transcription factor (ZFP TF) designed to up-regulate the expression of the gene encoding vascular endothelial growth factor.