MonoSol Rx and Strativa Pharmaceuticals Extend Strategic Relationship
January 05 2010 - 8:33AM
PR Newswire (US)
Option to collaborate on three new products Relationship built on
successful development of ondansetron oral soluble film currently
under FDA review WARREN, N.J., Jan. 5 /PRNewswire/ -- MonoSol Rx,
the developers of PharmFilm® technology and a drug delivery company
specializing in proprietary pharmaceutical film products, announced
today that it has entered into a new licensing and development
agreement that grants the option to develop three new products with
Strativa Pharmaceuticals, the proprietary products division of a
wholly owned subsidiary of Par Pharmaceutical Companies, Inc.
(NYSE: PRX). Strativa has the option to license exclusive U.S.
commercialization rights for the three additional oral soluble film
(OSF) products to be developed using MonoSol Rx's PharmFilm®
technology. The new option agreements are an extension of the
strategic relationship between MonoSol Rx and Strativa, initiated
in June 2008 when Strativa acquired exclusive U.S.
commercialization rights to MonoSol Rx's ondansetron OSF, which
will be marketed under the tradename Zuplenz(TM). The new drug
application (NDA) for Zuplenz(TM) was accepted for review by the
U.S. Food and Drug Administration (FDA) in June 2009, and a
response is expected in the first quarter of 2010 as mandated by
the Prescription Drug User Fee Act (PDUFA) guidelines. A. Mark
Schobel, president and chief executive officer of MonoSol Rx,
stated, "The Strativa corporate strategy is an ideal fit with the
MonoSol Rx partnering model, as demonstrated by our successful
development and regulatory submission of Zuplenz(TM) OSF. We
welcome the opportunity to expand our relationship for the
potential development and commercialization of three additional OSF
products that leverage the MonoSol Rx PharmFilm® technology. The
Strativa team has been a valuable partner for us and recognizes
that drug delivery via film may offer numerous benefits across the
entire pharmaceutical spectrum, from improving onset of action and
dosing accuracy to enhancing patient compliance to providing highly
differentiated drug products that can extend the revenue lifecycle
of soon to be expired or expired blockbuster compounds." Terms of
the new agreements provide the option to license and develop three
additional OSF products under a similar structure to the Companies'
ondansetron OSF exclusive licensing agreement, which entitles
MonoSol Rx to pre-commercialization and sales-based milestone
payments, as well as payments for the purchase of product supply
and royalties on net sales. Keith J. Kendall, executive vice
president and CFO of MonoSol Rx, commented, "These new agreements
with Strativa represent a direct endorsement, from a current
partner, that MonoSol Rx has the capabilities and technology
necessary to address the needs of the pharmaceutical industry. Our
strategy is to leverage film drug delivery to create new
partnership opportunities. These relationships generate incremental
streams of revenue for MonoSol Rx while providing an effective,
differentiated dosage form that potentially allows our partners to
preserve revenue lifecycles or compete more effectively in crowded
therapeutic markets. The success of our revenue-sharing business
model has led to the doubling of our revenue growth in each of the
past two years, and is anticipated to create similar returns in
2010 and beyond." About MonoSol Rx MonoSol Rx is a specialty
pharmaceutical company leveraging its proprietary PharmFilm®
technology to deliver unique proprietary pharmaceutical drug 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
over-the-counter (OTC) drug products, and a development pipeline of
prescription formulations based on PharmFilm® technology. With a
vertically integrated development and production infrastructure,
MonoSol Rx has the capacity to manufacture OTC drug products for
near-term revenues that fund prescription product development
programs that will generate long-term value. The Company'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). 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 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: MonoSol Rx: Keith Kendall
Chief Financial Officer (732) 564-5000 The Ruth Group (on behalf of
MonoSol Rx) Jason Rando (media) (646) 536-7025 Sara Pellegrino
(investors) (646) 536-7002 DATASOURCE: MonoSol Rx CONTACT: Keith
Kendall, MonoSol Rx, Chief Financial Officer, +1-732-564-5000; or
Jason Rando (media), +1-646-536-7025, , or Sara Pellegrino
(investors), +1-646-536-7002, , both of The Ruth Group (on behalf
of MonoSol Rx) Web Site: http://www.strativapharma.com/
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