FDA-approved Zuplenz oral soluble film now available for licensing to new commercial partners

MonoSol Rx, a specialty pharmaceutical company and the developers of the PharmFilm® technology platform, in collaboration with APR Applied Pharma Research s.a. of Switzerland ("APR"), announced today that its FDA-approved anti-emetic Zuplenz (Ondansetron) oral soluble film is available for licensing to new commercial partners.  The Company made the strategic decision to reacquire the commercial rights to Zuplenz from Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical, Inc. (NYSE: PRX), who had been marketing the product as part of an exclusive licensing agreement since its commercial launch in October 2010.  The New Drug Application (NDA) for Zuplenz will remain current and commercial availability will not be disrupted.

Zuplenz is a unique film formulation delivering either 4 or 8 mgs of ondansetron and was developed using MonoSol Rx's proprietary PharmFilm technology.  It is indicated for the prevention of postoperative nausea and vomiting (PONV), highly and moderately emetogenic cancer chemotherapy-induced nausea and vomiting (CINV), and radiotherapy-induced nausea and vomiting (RINV).  Zuplenz is poised to capture a broad share of this market, which generated $1.9 billion in 2010.

"Zuplenz provides patients suffering from nausea and vomiting as a result of chemotherapy or surgery with a minimally invasive and highly tolerable drug delivery form," said A. Mark Schobel, Chief Technology Officer and CEO, MonoSol Rx.  "We believe Zuplenz has the potential to improve the quality of life for many cancer patients in need of better supportive care and offers an important new dosage form for improving postoperative care for both inpatient and outpatient surgeries.  We look forward to maximizing this potential with a pharmaceutical partner that can effectively detail to physicians in the sizable U.S. market."

SOURCE MonoSol Rx