Navigation Links
Barr Confirms Patent Challenge of Eloxatin(R) Injectable, 5mg/mL
Date:1/9/2008

MONTVALE, N.J., Jan. 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Sanofi-Aventis U.S. LLC in connection with its Eloxatin(R) (Oxaliplatin Aqueous Solution), 5mg/mL Injectable.

Barr filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Eloxatin product with the U.S. Food & Drug Administration (FDA), and following FDA notification of the application's acceptance for filing, the Company notified the New Drug Application (NDA) and patent owner.

On January 4, 2008, Sanofi-Aventis U.S. LLC, Sanofi-Aventis and Debiopharm S.A. filed suit in the U.S. District Court of New Jersey to prevent the Company from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Eloxatin (Oxaliplatin Aqueous Solution), 5mg/mL Injectable, used in combination with infusional 5-FU/LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor, and is indicated for the treatment of advanced carcinoma of the colon or rectum. The product had sales of approximately $1.1 billion in the U.S., based on IMS sales data for the 12-months ended October 2007.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.


'/>"/>
SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Barr Confirms Patent Challenge of Focalin(R) XR
2. Recent Study Confirms Alimentary Healths Bifantis(R) Demonstrates Efficacy in the Treatment of Irritable Bowel Syndrome
3. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
4. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
5. Wyeth Will Pursue Claim for Damages Resulting From Teva Pharmaceuticals Launch of Generic Pantoprazole in Violation of PROTONIX Patent
6. Co-Inventor of Amgens Aranesp(R) Technology Directs Worldwide Patent Strategy for Diffusion Pharmaceuticals First-in-Class Oxygen Enhancing Therapeutics
7. Lonza Withdraws Majority of Claims in Patent Lawsuit Against Northwest Biotherapeutics
8. DermTech Is Issued U.S. Patent for the Early Detection, Staging and Monitoring of Melanoma
9. Odyssey Thera Granted U.S. Patent for Animal Imaging
10. Decision Biomarkers Awarded U.S. Patent for Protein Array Surface Chemistry
11. iCAD, Inc. Awarded Two Additional Patents for Its Computer-Aided Detection Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the ... at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application ... team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our ...
(Date:6/23/2016)... June 23, 2016 Apellis Pharmaceuticals, Inc. ... clinical trials of its complement C3 inhibitor, APL-2. ... multiple ascending dose studies designed to assess the ... subcutaneous injection in healthy adult volunteers. ... as a single dose (ranging from 45 to ...
(Date:6/23/2016)... 2016 Andrew D ... http://doi.org/10.17925/OHR.2016.12.01.22 Published recently in ... from touchONCOLOGY, Andrew D Zelenetz , discusses ... care is placing an increasing burden on healthcare ... therapies. With the patents on many biologics expiring, ...
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, the only free validated ... will showcase its product’s latest features from June 26 to June 30, 2016 ... on Disrupting Clinical Trials in The Cloud during the conference. DIA (Drug ...
Breaking Biology Technology:
(Date:6/22/2016)... ANGELES , June 22, 2016 /PRNewswire/ ... identity management and verification solutions, has partnered ... edge software solutions for Visitor Management, Self-Service ... provides products that add functional enhancements ... partnership provides corporations and venues with an ...
(Date:6/15/2016)... New York , June 15, 2016 /PRNewswire/ ... a new market report titled "Gesture Recognition Market by ... and Forecast, 2016 - 2024". According to the report, ... USD 11.60 billion in 2015 and is estimated ... reach USD 48.56 billion by 2024.  ...
(Date:6/2/2016)... LONDON , June 2, 2016 ... has awarded the 44 million US Dollar project, ... Security Embossed Vehicle Plates including Personalization, Enrolment, and IT Infrastructure ... world leader in the production and implementation of Identity Management ... in January, however Decatur was selected ...
Breaking Biology News(10 mins):