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news.To develop three additional OSF products
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MonoSol Rx has entered into a new licensing and development agreement that grants the option to develop three new products with Strativa Pharmaceuticals (Strativa). Strativa has the option to license exclusive US commercialisation rights for the three additional oral soluble film (OSF) products, to be developed using MonoSol’s PharmFilm technology.
Reportedly, the new option agreements are an extension of the strategic relationship between MonoSol Rx and Strativa initiated in June 2008, when Strativa acquired exclusive US commercialisation rights to MonoSol Rx’s ondansetron OSF, which will be marketed under the tradename Zuplenz.
The new drug application (NDA) for Zuplenz was accepted for review by the FDA in June 2009, and a response is expected in the first quarter of 2010 as mandated by the Prescription Drug User Fee Act (PDUFA) guidelines, said the company.
The terms of the new agreements provide the option to license and develop three additional OSF products under a similar structure to the companies’ ondansetron OSF exclusive licensing agreement, which entitles MonoSol Rx to pre-commercialisation and sales-based milestone payments, as well as payments for the purchase of product supply and royalties on net sales.
Mark Schobel, president and CEO of MonoSol Rx, said: “The Strativa corporate strategy is an ideal fit with the MonoSol Rx partnering model, as demonstrated by our successful development and regulatory submission of Zuplenz OSF. We welcome the opportunity to expand our relationship for the potential development and commercialisation of three additional OSF products that leverage the MonoSol Rx PharmFilm technology.
“The Strativa team has been a valuable partner for us and recognises that drug delivery via film may offer numerous benefits across the entire pharmaceutical spectrum, from improving onset of action and dosing accuracy to enhancing patient compliance to providing highly differentiated drug products that can extend the revenue lifecycle of soon to be expired or expired blockbuster compounds.”