Navigation Links
MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA
Date:12/2/2008

Expects to File NDA with FDA in Early to Mid-2009

WARREN, N.J.,Dec. 2 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced the successful completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron. The ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Subject to final review of the data and discussions with the Food and Drug Administration (FDA), it is anticipated that MonoSol Rx and Strativa could file a New Drug Application (NDA) in early to mid 2009.

In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for the purchase of product supply and royalties on net sales. The successful achievement of all pivotal bioequivalence studies triggered a milestone payment to MonoSol Rx.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "Completion of the pivotal bioequivalence trials is a significant milestone in the development and commercialization process for our thin film ondansetron formulation. Working with our licensing partner, Strativa Pharmaceuticals, we were able to demonstrate that our PharmFilm(R) formulation is bioequivalent to the FDA approved Zofran ODT(R) product in all human clinical trials. Looking ahead, we are now working diligently with Strativa to complete and file the NDA with the FDA in early to mid-2009."

Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.8 billion in 2007 at a prescription drug price. Ondansetron was a prescription leader in the category in 2007, with 2.7 million scripts written. MonoSol Rx's thin film formulation of ondansetron was studied against GlaxoSmithKline's Zofran ODT(R) product.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films. PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that enable the funding of prescription product development programs that will generate long-term value.

The Company's commercialization strategy for all PharmFilm(R) products is to partner with the innovator or other specialty pharma or leading consumer products companies who have the core competency to sell-in and manage the sales and marketing of the products. For the Company's existing and future partners, PharmFilm(R) formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) 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 ODTs.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch. For additional information, please visit www.strativapharma.com

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com

    Contacts:

    MonoSol Rx:
    Keith Kendall
    Chief Financial Officer
    (732) 564-5000

    The Ruth Group (on behalf of MonoSol Rx)
    Jason Rando (media)
    (646) 536-7025
    jrando@theruthgroup.com

    Stephanie Carrington / Sara Ephraim (investors)
    (646) 536-7017/7002
    scarrington@theruthgroup.com
    sephraim@theruthgroup.com


'/>"/>
SOURCE MonoSol Rx
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. MonoSol Rx Granted US Patent for Thin Film Manufacturing Process
2. MonoSol Rx Names Vincent Viviani Senior Vice President, Manufacturing and Operations
3. MonoSol Rx Licenses Thin Film Formulation of Ondansetron to Strativa Pharmaceuticals, a Division of Par Pharmaceutical
4. Strativa Pharmaceuticals Acquires Commercialization Rights to Thin Film Formulation of Ondansetron From MonoSol Rx
5. MonoSol Rx to Present at the 20th Annual Piper Jaffray Health Care Conference
6. Eligard(R) six-month formulation successfully completes European approval procedure
7. AHFs Innovative Stay Negative HIV Prevention Campaign Successfully Breaks Through to Target Audience
8. Health Campaign to Protect Indonesian Children Successfully Completed
9. How one virus uses mimicry to replicate successfully
10. New study in the journal Sleep finds that catathrenia can be successfully treated with CPAP
11. The Ensign Group Successfully Graduates Troubled Nursing Home from CMS Special Focus Facility Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... ... jointly issued a letter to withdraw previous guidance issued by the ... identity. The guidance issued in May 2016 by the Obama Administration came in ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... ... organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community ... will return to the La Gorce Country Club in Miami Beach to host ...
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased ... KLS is a longtime supporter of the event. , "We are pleased that KLS ... Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track record of ...
(Date:2/23/2017)... ... 23, 2017 , ... Hamlin Dental Group and Dr. Hamid Reza, dentist ... Throughout the month of February, patients who visit Hamlin Dental Group will receive a ... for two at the Cheesecake Factory. , Tickets are available for routine dental ...
(Date:2/23/2017)... ... 2017 , ... EBSCO Information Services (EBSCO) has ... Health and Care Excellence (NICE) framework. The agreement allows purchasers from libraries, ... search, order and purchase medical and healthcare-related content through GOBI ®, the ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... Md. , Feb. 23, 2017 ... marketing of the PhenoTest BC Kit, performed on ... to identify organisms that cause bloodstream infections and ... likely to respond to (antibiotic sensitivity). The test ... to provide this important information, which can guide ...
(Date:2/24/2017)... MELBOURNE , Australien, 24. Februar 2017 /PRNewswire/ ... innovatives, diversifiziertes Unternehmen des Gesundheitsbereiches, ist erfreut, für ... Vergleich mit dem entsprechenden Vorjahreszeitraum exzellente Ergebnisse vorlegen ... BioMedical und Aktualisierung zum Wachstum" finden Sie ... Gewinn nach Steuern 2,12 Millionen USD (Dez. 2015: ...
(Date:2/24/2017)... , Feb. 23, 2017  Directors from Pharma To Market ... companies have joined forces, resulting in the founding of Pharma To ... Pharma To Market are pleased to announce their expansion into ... in Singapore . The company are delighted to ... Co-Director of the Singapore based entity. Joelle ...
Breaking Medicine Technology: