Regulatory dossier is being prepared for EU filing of dissolving film-based Alzheimer drug.
Partners APR Applied Pharma Research and Labtec singed an exclusive licensing agreement with Ferrer Internacional under which the latter will promote, distribute, and market their Donepezil Oral Dispersible Film (ODF) product for the symptomatic treatment of Alzheimer disease in Spain, Portugal, and Germany. Currently being prepared for submission to the EU regulatory authorities, the oral thin film product is one in a pipeline of ODF prescription products in development by Labtec and APR, based on Labtec’s Rapidfilm® technology.
Focused primarily on products for pain and central nervous system indications, the joint clinical pipeline includes ODF formulations of ondansetron (emesis), donepezil (Alzheimer disease), olanzapine (schizophrenia), and zolmitriptan (migraine). Labtec is separately developing an ODF formulation of aripiprazole for schizophrenia therapy.
“The future of many molecules to become off-patent such as donepezil will be determined by dosage form diversification and patient compliance,” remarks Paulo Galfetti, CEO at APR. “ODF is certainly the oral dosage form contributing the most to compliance by ensuring drug delivery while being easy to use without any discomfort for patients and doctors.”
In March 16 European countries approved Setofilm®, a film strip formulation containing 4 mg and 8 mg ondansetron, which was co-developed by APR, Labtec, and MonoSol Rx and licensed to BioAlliance for marketing in Europe. The firms claim the product is the first film strip prescription drug to have received approval anywhere in the world.
U.S. approval of the ondansetron film product, trademarked Zuplenz®, was signed off in July. MonoSol granted Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceuticals, U.S. commercialization rights to the ondansetron OSF product in 2008.
Earlier this month Labtec and APR reported successful completion of a Phase III study with the zolmitriptan ODF product. They also confirmed plans to submit the drug to the European authorities during October. Zolmitriptan ODF drug has also been developed in collaboration with Monosol Rx as a result of the latter’s June expansion of its film formulations collaboration agreement with APR to include zolmitriptan as well as the original target drugs, ondansetron and donepezil.
“We are expecting an expeditious process for the U.S. approval of Zolmitriptan Oral Soluble Film,”, commented Mark Schobel, president and CEO of MonoSol Rx, on announcement of the pivotal trial completion. “The submission of the zolmitriptan OSF IND is planned for December 2010 and the filing for approval using a 505(b)2 procedure is expected by end of 2011, one year prior to the end of zolmitriptan’s exclusivity in 2013.”