`
`https://globenewswire.com/news-release/2016/11/28/893090/0/en/Mono...
`
`November 28, 2016 08:30 ET | Source: MonoSol Rx
`
`Warren N.J., Nov. 28, 2016 (GLOBE NEWSWIRE) -- MonoSol Rx, a specialty pharmaceutical
`company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and
`to address unmet needs, today announced that it has filed a New Drug Application (NDA) with
`
`the U.S. Food and Drug Administration (FDA) for Tadalafil PharmFilm for the treatment of
`
`erectile dysfunction.
`
`“The filing of the NDA for Tadalafil PharmFilm is a significant milestone for MonoSol Rx and
`
`provides further evidence of the world-class capabilities of our development team. This
`
`application follows the successful completion of a pivotal pharmacokinetic study and a
`
`productive meeting with the FDA earlier this year,” said Dan Barber, Vice President of MonoSol
`
`Rx. “We believe that our product is well-positioned to compete in the multi-billion dollar erectile
`
`dysfunction market, based on its status as the first alternative to tadalafil tablets to file for FDA
`
`approval and our strong protective portfolio of patents. We look forward to working through the
`
`review process as we bring this innovative product to market.”
`
`Tadalafil is a PDE5 inhibitor currently marketed in pill form for the treatment of erectile
`dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis®, and for
`treatment of pulmonary arterial hypertension under the brand name Adcirca®. Tadalafil
`PharmFilm will be offered in single pack doses and is expected to have several Orange Book
`
`listed patents upon approval.
`
`MonoSol Rx is currently exploring partnership opportunities for Tadalafil PharmFilm and has
`
`engaged ESC Advisors, a division of KEMA Partners LLC, to manage the partnering process.
`
`About MonoSol Rx
`
`MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug
`
`delivery technology to develop products that improve patient outcomes and address unmet
`
`needs. PharmFilm can benefit patients by improving the efficacy, safety, and compliance of
`
`pharmaceutical and over-the-counter products. MonoSol Rx 's leadership in film drug delivery is
`
`supported by strong IP protection, a robust pipeline of prescription drug formulations, and two
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`1 of 2
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`ICOS Exhibit 2003
`MonoSol v. ICOS
`IPR2017-00412
`
`Page 1 of 2
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`
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`MonoSol Rx Submits New Drug Application for Tadalafil PharmFilm®
`
`https://globenewswire.com/news-release/2016/11/28/893090/0/en/Mono...
`
`FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and
`Zuplenz® (ondansetron) oral soluble film. For press releases and other company information,
`visit www.monosolrx.com.
`
`Contact
`
`MonoSol Rx
`Jessica Patel
`jpatel@monosolrx.com
`
`The Ruth Group
`Lee Roth
`lroth@theruthgroup.com
`(646) 536-7012
`
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`
`Corporate Headquarters
`2321 Rosecrans Avenue.
`Suite 2200
`El Segundo, CA 90245
`Phone: (800) 307-6627
`Fax: (800) 307-3567
`
`European Headquarters
`Woolgate Exchange,
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`UK
`Phone: +1 866-465-8454
`
`© 2017 GlobeNewswire, Inc. All Rights Reserved.
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