Navigation Links
Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis

WOODCLIFF LAKE, N.J., April 21 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its development partner, BioAlliance Pharma reported preliminary, top-line results for a Phase III study of Loramyc(R) (miconazole Lauriad(R)) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC).

Top line data show that Loramyc(R) achieved its primary endpoint of noninferiority to Mycelex(R) Troche (clotrimazole)* in the complete resolution of signs and symptoms of OPC (complete clinical cure). The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa. All secondary endpoints were also met.

Loramyc(R), which is approved in Europe and currently being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing of the active ingredient at the site of infection.

In July 2007, Par Pharmaceutical, Inc. entered into an exclusive licensing agreement under which Par received commercialization rights in the U.S. to BioAlliance Pharma's Loramyc(R) (miconazole Lauriad(R)). In return for the commercialization rights to Loramyc(R), Par paid BioAlliance an initial payment of $15 million, which Par incurred as a research and development (R&D) expense in 2007. Upon FDA approval of the product, Par will also pay BioAlliance $20 million. In addition to royalties on sales, BioAlliance may receive milestone payments on future sales.

John MacPhee, president of Strativa Pharmaceuticals, said, "We are pleased with the results of this trial. There is a significant need for this innovative treatment option for patients suffering with OPC and their healthcare providers." Mr. MacPhee continued, "Subject to a favorable review of the full study results and discussions with the FDA, an NDA could be filed in the 2nd half of 2008."

About Strativa

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 introduction and to help ensure their success after launch. For additional information, please visit

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

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

Safe Harbor Statement

Certain statements in this press 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 risks and uncertainties, including the extent and impact of litigation arising out of the accounting issues described in the Company's filings with the Securities and Exchange Commission (SEC), the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the Company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the SEC, such as the Company's reports on Form 10-K, Form 10-Q and Form 8-K, and amendments thereto. Any forward-looking statements included in this press 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.

*MYCELEX(R) is a registered trademark of Bayer Healthcare LLC

SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Raptor Pharmaceuticals Corp. Initiates Phase IIa Clinical Study for Convivia(TM)
2. Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
3. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
4. Alseres Pharmaceuticals Expands Sites for the First Stage of the ALTROPANE(R) Phase III Clinical Trial Program
5. Celator(R) Pharmaceuticals Successfully Uses Nanoparticles to Administer Hydrophobic Drug Combinations
6. Sunesis Pharmaceuticals Reports Data from Nonclinical Studies of SNS-032 at the Annual Meeting of the American Association for Cancer Research
7. Rib-X Pharmaceuticals Renews Collaborative Agreement with the Medical Research Council
8. Poniard Pharmaceuticals Oral Picoplatin Demonstrates Positive Bioavailability in Ongoing Phase 1 Trial
9. Antipodean Pharmaceuticals Announces Completion of Phase 2 Study of Lead Compound MitoQ(R)
10. Sunesis Pharmaceuticals to Present Non-Clinical Data at the Annual Meeting of the American Association for Cancer Research
11. Poniard Pharmaceuticals Announces Presentation of Clinical Data From Picoplatin Phase 2 Small Cell Lung Cancer Trial to be Presented at 1st IASLC-ESMO European Lung Cancer Conference
Post Your Comments:
(Date:11/30/2015)... 2015  Hanger, Inc. (NYSE: HGR ) (the ... terms of its previously announced consent solicitation (as amended ... aggregate principal amount 7⅛% Senior Notes due 2018 (the ... fees payable pursuant to the Consent Solicitation, (ii) the ... the expiration date of the Consent Solicitation.    ...
(Date:11/30/2015)... , Nov. 30, 2015  Precision Image Analysis ... is pleased to announce a dramatic expansion of ... services. Building on its ISO-9001:2008 certification for its ... comprehensive Core Lab protocols and procedures. This expansion ... research activities.  Their Core Lab services include design ...
(Date:11/30/2015)... and REHOVOT, Israel , ... specialty pharmaceutical company focused on acquiring and developing innovative ... announced the appointment of Keith A. Katkin ... Gregory J. Flesher , chief executive officer for ... building successful organizations.  As chairman, he will be able ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Brenntag Specialties, Inc. (BSI) has ... the Nutraceutical Specialties products into oral solid dosage in the over the counter ... are pleased to announce our expanded distribution agreement with ASI.” said Steve Brauer, ...
(Date:11/30/2015)... ... November 30, 2015 , ... California-based i2i Systems, ... announced today that Michigan-based Family Health Center (FHC) has selected i2iTracks as their ... FHC was awarded the largest Affordable Care Act grant for Federally Qualified Health ...
(Date:11/30/2015)... ... November 30, 2015 , ... An inventor from Charlottesville, Va., is ... "My last baby had high blood pressure due to loud noises," she said, "so ... babies from noise pollution as well as radio waves and microwaves." , The baby ...
(Date:11/30/2015)... ... November 30, 2015 , ... In an interview with Andy Mitchell of Peconic ... on Long Island’s east end. During the broadcast, entitled “Eyes: the Window to the ... glaucoma and cataracts, and how a visit with his grandmother to her physician put ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... magazines and websites specializing in independent living, assisted living and all other retirement ... Alzheimer’s awareness and research remains a top priority. , So ...
Breaking Medicine News(10 mins):