MonoSol Rx, LLC Announces Suboxone Sublingual Film Achieves 25% Share of Total U.S. Suboxone Market Volume at Year-End 2010
WARREN, N.J., Feb. 22, 2011 /PRNewswire/ — MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilmÃ‚® drug delivery technology, today announced that Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (“the Group”) (LSE: RB), provided an update on U.S. market adoption of SuboxoneÃ‚® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence during its announcement of full-year 2010 financial results.
Full-year 2010 net revenue for the Group’s Subutex and Suboxone prescription drug business grew 24% to 737 million pounds Sterling. At the end of 2010, the market volume share for Suboxone sublingual film was 25%, and at this level would represent approximately 23% of the total U.S. net revenue for Reckitt Benckiser Pharmaceuticals Inc. (approximately 138m pounds on an annualized basis).
Suboxone sublingual film was developed through an exclusive agreement with Reckitt Benckiser Pharmaceuticals and MonoSol Rx, utilizing MonoSol Rx’s proprietary PharmFilmÃ‚® technology, to deliver a convenient, quick-dissolving better tasting therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure efficacy and compliance.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, “The patients and treating physicians acceptance of Suboxone sublingual film demonstrates not only the advantages of our dosage form but also the value we create for our partners as they look to protect their product franchises following exclusivity losses. We are very happy with the market penetration of the new Suboxone sublingual films and are looking forward to continued success in 2011 and beyond.”
On October 8, 2009, Suboxone lost the U.S. exclusivity afforded by its orphan drug status. In September 2010, Reckitt-Benckiser Pharmaceuticals introduced Suboxone sublingual film, a patent-protected and patient-preferred delivery system, to address the potential loss of up to 80% of the revenues and profits of the Suboxone tablet business in the year following the launch of prospective generic competitors.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilmÃ‚® technology to deliver drugs in films. PharmFilmÃ‚® 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 PharmFilmÃ‚® technology, and two recent FDA approvals – ZuplenzÃ‚®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and SuboxoneÃ‚® sublingual film, the first sublingual film product for the treatment of opioid dependence.
MonoSol Rx’s commercialization strategy for all PharmFilmÃ‚® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilmÃ‚® 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 existing and future partners, PharmFilmÃ‚® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. For press releases and other company information visit www.monosolrx.com
Contacts: MonoSol Rx Keith Kendall, Executive Vice President (732) 564-5000 The Ruth Group (on behalf of MonoSol Rx) Jason Rando (media) Tel: +1 (646) 536-7025 firstname.lastname@example.org Sara Pellegrino (investors) Tel: +1 (646) 536-7002 email@example.com
SOURCE MonoSol Rx, LLC