Navigation Links
Strativa Pharmaceuticals Provides Product Pipeline Update
Date:4/20/2009

Files NDA for Ondansetron Orally Dissolving Film Strip

BioAlliance to Resubmit Loramyc(R) NDA

WOODCLIFF LAKE, N.J., April 9 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today provides an update on two of its pipeline products.

Ondansetron Orally Dissolving Film Strip

On April 7, 2009, Strativa submitted a New Drug Application (NDA) for its new orally dissolving film strips (ODFS) formulation of ondansetron to the U.S. Food and Drug Administration (FDA). Strativa is seeking approval of ondansetron ODFS in 8 mg and 4 mg strengths for the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of post-operative nausea and vomiting.

A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to Zofran ODT(R) 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions.

The antiemetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.

In June 2008, Strativa acquired the commercialization rights in the United States and its territories to ondansetron ODFS from MonoSol Rx. To date, Strativa has paid MonoSol Rx a total of $3.5 million for the completion of certain milestones.

Loramyc(R) (miconazole Lauriad) for the treatment of oropharyngeal candidiasis (OPC)

After preliminary review, the FDA has informed BioAlliance Pharma, Strativa's development partner, that the agency did not accept its NDA for Loramyc(R) (miconazole) mucoadhesive buccal tablet (MBT) based on the lack of an imprint code on the tablet. Loramyc was approved in the European Union in 2007 and is currently marketed in several EU territories. The EU does not require an imprint code while the U.S. requires an imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of a debossed tablet and will soon after resubmit the Loramyc application.

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.

About BioAlliance Pharma

BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The Company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.com.

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 new and currently marketed drugs. The Company's leadership in thin 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(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 fund 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, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For 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 orally disintegrating tablets (ODTs).

Safe Harbor Statement

Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2007, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.


'/>"/>
SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. MonoSol Rx Licenses Thin Film Formulation of Ondansetron to Strativa Pharmaceuticals, a Division of Par Pharmaceutical
2. Strativa Pharmaceuticals Acquires Commercialization Rights to Thin Film Formulation of Ondansetron From MonoSol Rx
3. Strativa Pharmaceuticals Acquires Worldwide Rights to Nascobal(R) (Cyanocobalamin, USP) Nasal Spray From QOL Medical
4. MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
5. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
8. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
9. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
10. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
11. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... today its affiliation with Tennessee Counseling Association. This new relationship allows ... the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, ... remain in the eye of the beholder, according to experts who offered insights and ... Journal of Managed Care. For the full issue, click here . , For ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... "The World Market for Companion Diagnostic Tests" report to ... World Market for Companion Diagnostics The World ... diagnostic and personalized medicine diagnostics. Market analysis in the report ... Diagnostics Test Market (In Vitro Diagnostic Kits) by Region (N. ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
Breaking Medicine Technology: