Reacquires Commercial Rights from Strativa Pharmaceuticals
Addresses Multi-billion Dollar U.S. Anti-Emetic Market
Warren, NJ (July 11th, 2011) – 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.”
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals – Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first combination sublingual film product for the treatment of opioid dependence.
MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs). For press releases and other company information visit www.monosolrx.com
About APR Applied Pharma Research
APR Applied Pharma Research s.a. is an independent, international and integrated Healthcare Company headquartered in Switzerland with a subsidiary in Charlotte (NC, USA) and focused on three major areas: Delivering, Funding and Supporting Innovation in Healthcare. In particular, APR develops and licenses innovative, value added and patented healthcare products and proprietary drug delivery systems primarily in the oral and topical fields; APR also invests in companies or early stage innovative projects and provides a balanced mix of equity funding and/or financing together with APR’s development, scientific, technical, marketing, licensing and management skills and know how; finally, APR supports biotech and pharmaceutical companies in the development of new pharmaceutical projects by providing on a contract basis added value, consultancy and R&D services under contract using a General Contractor approach. APR has entered into licensing and partnership agreements with pharmaceutical companies in over 100 countries worldwide with international sales on a worldwide basis.