Navigation Links
MonoSol Rx Licenses Thin Film Formulation of Ondansetron to Strativa Pharmaceuticals, a Division of Par Pharmaceutical
Date:6/17/2008

MonoSol Rx to initiate pivotal trials for ondansetron thin film immediately

WARREN, N.J. and PORTAGE, Ind., June 17 /PRNewswire/ -- MonoSol Rx, a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announced today that they have entered into an exclusive licensing agreement under which Strativa has acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. The ondansetron thin film formulation is a new oral formulation in development for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Based on the results of a recently completed pilot bio-equivalency study, MonoSol Rx is initiating pivotal trials immediately to enable application for drug approval in the U.S. Subject to favorable results, it is anticipated that Strativa could file an NDA with the appropriate regulatory authorities within the next twelve months.

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 purchase of product supply and royalties on net sales.

Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.6 billion in 2007. Ondansetron was the prescription leader in the category in 2007, with 2.7 million scripts written.

A. Mark Schobel, president and CEO of MonoSol Rx, stated, "We are very excited about the collaboration with Strativa. They are uniquely positioned to market and sell our ondansetron thin film product given their focus on marketing novel prescription drugs. Thin film is particularly well suited for this indication because patients who are prescribed ondansetron often have difficulty swallowing due to extreme nausea caused by chemotherapy and radiation treatments. Following approval, ondansetron would be one of the first prescription drugs to come to market utilizing thin film drug delivery technology."

John A. MacPhee, president of Strativa, said, "We are delighted to collaborate with MonoSol Rx and expand our pipeline of supportive care products. With two unique, yet complementary delivery systems of ondansetron in our portfolio, Zensana(TM) oral spray and the oral thin film, we are able to offer patients a better opportunity to find a product that meets their individual needs."

Keith J. Kendall, executive vice president and CFO of MonoSol Rx, stated, "The financial components of this relationship demonstrate the value of MonoSol Rx's intellectual property, expertise in thin film development and manufacturing as well as our ability to partner for the commercialization of innovative thin film products."

About MonoSol Rx

MonoSol Rx is a drug delivery company specializing in proprietary, dissolving thin film pharmaceutical products. The Company's thin film technology, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. The Company's thin film formulations offer significant patient benefits, including convenience, taste, and potentially greater efficacy. MonoSol Rx's strategy is to develop and partner innovative thin film strip products in the prescription, generic and OTC pharmaceutical markets and to establish a leadership position in thin film drug delivery technology through continued development of its drug delivery technology and intellectual property portfolio. For additional information, please visit http://www.monosolrx.com.

About Strativa

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par's financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals 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 introduction and to help ensure their success after launch. For additional information, please visit http://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 http://www.parpharm.com.

Contacts:

For MonoSol Rx:

Jason Rando/Stephanie Carrington

The Ruth Group

646.536.7025/7017

jrando@theruthgroup.com

scarrington@theruthgroup.com


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

Related medicine news :

1. MonoSol Rx Names Vincent Viviani Senior Vice President, Manufacturing and Operations
2. MonoSol Rx Granted US Patent for Thin Film Manufacturing Process
3. Syntermed licenses Emory imaging technology for improved evaluation of heart failure patients
4. KineMed Licenses GeneGos MetaCore
5. Xceed Molecular Licenses Signature from Moffitt Cancer Center and Adds Moffitt to Strategic Collaborator Program
6. Nuvo licenses topical pain product from Paladin
7. ACT Biotech Acquires Clinical and Early Stage Oncology Portfolio Licenses From Bayer Healthcare
8. TorreyPines Therapeutics Licenses Intellectual Property from Johns Hopkins Related to Novel Uses of Glutamate Receptor Antagonists for Prevention, Treatment of Stroke, Heart Attack
9. Indevus Pharmaceuticals Licenses European Rights for VANTAS(R) to Orion Corporation
10. Sigma-Aldrich Licenses From NeuroSurvival Technologies a Leading Marker for Molecular Imaging of Apoptosis in Vivo
11. RHEI Pharmaceuticals Licenses Attental From MethaPharma (Vemedia Group) for Distribution Throughout Asia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... ... January 23, 2017 , ... Moisture measurement ... the right method is paramount to success. Selecting an inappropriate measurement method can ... multiple persons use the same equipment. Rare or expensive substances are wasted and ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... general gynecological care and gynecological services for women of all ages. ... for a wide variety of reproductive services from routine health screenings to diagnosing ...
(Date:1/23/2017)... ... January 23, 2017 , ... “Some Infallible Characteristics of Christ”: a ... Characteristics of Christ” is the creation of published author, Rev. Dr. Robert W. Thomas, ... thirteen years, a preacher for over nineteen, a pastor for over fifteen years. He ...
(Date:1/22/2017)... , ... January 22, 2017 , ... Medical lab ... results. Often the results of a simple test will take days to arrive to ... Test Now offers customers direct access to their lab tests, bypassing the cost and ...
(Date:1/21/2017)... ... , ... Phytocéane invites you to take an exotic journey deep ... with ZANZIBAR SHOWER GEL. Inspired by the beauty of Zanzibar, a Tanzanian archipelago off ... vegetal coral to create this gentle, crystal-clear shower gel to cleanse the body and ...
Breaking Medicine News(10 mins):
(Date:1/22/2017)... Switzerland and ABU DHABI , Saudi ... from the US ... , Hospital of the Future , at the ... the hospital of the future will be driven by big data and powered ... according to the panel of experts that discussed the ,Hospital of the Future, ...
(Date:1/21/2017)... According to a new market research report "Life Science ... Component (Software, Service), Delivery (On premise, Cloud), End user (Pharmaceutical, Biotechnology, ... market is expected to reach USD 24.73 Billion by 2021 from ... the forecast period. Continue Reading ... ...
(Date:1/21/2017)... -- Research and Markets has announced the addition of ... Route Of Administration, End User - Forecast to 2025" report ... ... a CAGR of around 7.8% over the next decade to reach ... analyzes the global markets for Advanced Drug Delivery across all the ...
Breaking Medicine Technology: