MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, announced today that it has entered into a new licensing and development agreement that grants the option to develop three new products with Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. ( PRX).
Strativa has the option to license exclusive U.S. commercialization rights for the three additional oral soluble film (OSF) products to be developed using MonoSol Rx's PharmFilm® technology.
The new option agreements are an extension of the strategic relationship between MonoSol Rx and Strativa, initiated in June 2008 when Strativa acquired exclusive U.S. commercialization rights to MonoSol Rx's ondansetron OSF, which will be marketed under the tradename Zuplenz(TM). The new drug application (NDA) for Zuplenz(TM) was accepted for review by the U.S. Food and Drug Administration (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.
A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "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(TM) OSF. We welcome the opportunity to expand our relationship for the potential development and commercialization of three additional OSF products that leverage the MonoSol Rx PharmFilm® technology. The Strativa team has been a valuable partner for us and recognizes 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."
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-commercialization and sales-based milestone payments, as well as payments for the purchase of product supply and royalties on net sales.
Keith J. Kendall, executive vice president and CFO of MonoSol Rx, commented, "These new agreements with Strativa represent a direct endorsement, from a current partner, that MonoSol Rx has the capabilities and technology necessary to address the needs of the pharmaceutical industry. Our strategy is to leverage film drug delivery to create new partnership opportunities. These relationships generate incremental streams of revenue for MonoSol Rx while providing an effective, differentiated dosage form that potentially allows our partners to preserve revenue lifecycles or compete more effectively in crowded therapeutic markets. The success of our revenue-sharing business model has led to the doubling of our revenue growth in each of the past two years, and is anticipated to create similar returns in 2010 and beyond."
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