The latest news from academia, regulators
research labs and other things of interest
Posted: May 04, 2011
Aptuit Will Manufacture Iroko's Phase III Lower-Dose NSAID Programs Formulated Using the SoluMatrix Nanotechnology Platform
(Nanowerk News) Iroko Pharmaceuticals, LLC and Aptuit Inc. announced today that Aptuit will provide manufacturing scale-up services as Iroko progresses its novel pain medications to Phase III clinical trials.
Under the services agreement, Aptuit will produce for Iroko Phase III supplies of lower dose, nanotechnology formulations for multiple nonsteroidal anti-inflammatory drugs (NSAIDs). Iroko has already completed Phase II studies for all of these products. Aptuit will also make batch material to satisfy requirements for product registrations.
While serving as a contract manufacturer, Aptuit will make use of the proprietary SoluMatrix™ technology of Iroko partner iCeutica Inc (recently acquired by Iroko on April 26, 2011 as announced in a previous press release). This nanoformulation technology makes possible the production of medications consisting of sub-micron, fast-dissolving drug particles.
John Vavricka, Iroko's Chief Executive Officer, commented, "Our strategic focus responds to the directive of the US Food and Drug Administration that NSAIDs should be used at the lowest effective dose for the shortest possible duration.1) We believe our patented nanoformulations will enable the development of NSAIDs at significantly lower doses without compromising onset of action or effectiveness. The consistent quality and attention to detail which Aptuit brings to its work will be an important resource as we advance these products toward the market."
"The confidence Iroko has placed in our ability to support them through this project as they progress their Phase III programs is a testament to the expertise of our team and the rigor of our science," said Timothy Tyson, Executive Chairman and Chief Executive Officer of Aptuit. "We look forward to working closely with Iroko to deliver a complete range of manufacturing services and to serve as a partner in advancing these important products."
Iroko Pharmaceuticals, LLC is a pharmaceutical company committed to the development and commercialization of currently marketed pharmaceutical products in specialty therapeutic areas. Iroko is focused on the maximization of the revenue potential of these products through directed selling and marketing efforts and product-life-cycle management activities including development of new formulations to improve patient therapies. Iroko currently has several products under development using iCeutica's proprietary SoluMatrix™ Platform. More information about Iroko is available at http://www.iroko.com.
Aptuit Inc. is a global pharmaceutical services company focused on delivering contract development and manufacturing services and streamlining the drug development process for biotechnology and pharmaceutical innovators. Aptuit's employees deliver an integrated suite of product development services to more than 800 companies worldwide, driven by a deep commitment to client service, quality and an unrivaled track record of scientific excellence. The company is partnered with Welsh, Carson, Anderson & Stowe, one of the world's leading private equity investors. For more information about Aptuit, please visit www.aptuit.com, or for more information about Aptuit's acquisition of the Verona Medicines Research Centre operations, please visit www.aptuit.com/Verona.
1) Source: Public Health Advisory – FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDS). July 7, 2005.