Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, disclosed that its licensee, Spectrum Pharmaceuticals, Inc., announced that it has launched Marqibo through its existing hematology sales force in the United States and has shipped the first commercial orders. Tekmira is entitled to royalty payments based on Marqibo's commercial sales.
"We are pleased that Marqibo — an innovative cancer treatment based on Tekmira technology — has been successfully launched in the United States with orders already being shipped. The sales of Marqibo represent a recurring revenue stream for Tekmira. Furthermore, with two ongoing Phase III trials, we anticipate data evaluating Marqibo in expanded oncology indications," said Dr. Mark J. Murray, Tekmira's President and CEO.
Marqibo, which is a novel, sphingomyelin/cholesterol liposome-encapsulated formulation of the FDA-approved anticancer drug vincristine originally developed by Tekmira, was licensed from Tekmira to Talon Therapeutics in 2006. In July 2013, Talon was acquired by Spectrum Pharmaceuticals, Inc. Marqibo's approved indication is for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy.
For more detailed information about the commercial launch of Marqibo, please refer to Spectrum's news release dated September 3, 2013, which can be found at http://www.sppirx.com. The full prescribing information for Marqibo can be found at www.marqibo.com.
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a broad number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira's LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.