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MonoSol Rx Announces Reckitt Benckiser FDA Approval of Suboxone® Sublingual Film for Treatment of Opioid Dependence

WARREN, N.J., Aug. 31 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence.

This is the second U.S. marketing authorization for a prescription product based on MonoSol Rx's PharmFilm® technology, closely following the July 2010 FDA approval of the anti-emetic Zuplenz® (ondansetron) oral soluble film.

Suboxone® sublingual film delivers a convenient, quick-dissolving therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure compliance.

A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are very pleased to announce the approval of Suboxone® sublingual film and disclose our important relationship with Reckitt Benckiser. Following the FDA approvals of Suboxone® sublingual film and Zuplenz® oral soluble film, both within the past two months, the agency has clearly accepted our proprietary PharmFilm® technology as a viable prescription drug dosage form.  

"The success of Suboxone® sublingual film through our collaboration with Reckitt Benckiser is another example of the significant value our PharmFilm® technology delivers to leading pharmaceutical companies, and further validates the commercial potential of film drug delivery for this industry. We look forward to working closely with Reckitt Benckiser to prepare for the launch. Upcoming royalty and supply revenues under this agreement are expected to support our pipeline and provide further confirmation of the acceptability of PharmFilm® for future partners."

Suboxone® sublingual film was developed under a previously undisclosed collaboration between MonoSol Rx and Reckitt Benckiser Pharmaceuticals Inc., in which Reckitt Benckiser's Suboxone® products were formulated utilizing MonoSol Rx's PharmFilm® technology. Under the world-wide agreement, MonoSol Rx will manufacture Suboxone® sublingual films and Reckitt Benckiser will leverage its existing Suboxone® sales force to market the product. MonoSol Rx is eligible to receive pre-launch milestone payments, development fees, supply payments and royalties on net sales.  

Shaun Thaxter, President of Reckitt Benckiser Pharmaceuticals Inc., said, "We are pleased that our positive working relationship with MonoSol Rx has resulted in FDA approval of Suboxone® sublingual film. The development of Suboxone® sublingual film through our exclusive agreement with MonoSol Rx reinforces our commitment to our addiction therapy franchise and to its development.  During clinical studies, Suboxone® sublingual film was shown to be faster dissolving than Suboxone® sublingual tablets, and patients preferred the film. Our partnership with MonoSol Rx, represents a strategic business opportunity which will contribute to the longevity of Suboxone® in the U.S."

About MonoSol RxMonoSol 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 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 Contact:The Ruth GroupJason Rando (media)

(646) 536-7025 Sara Pellegrino (investors)

(646) 536-7002 MonoSol RxKeith Kendall

Executive Vice President

(732) 564-5000

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