Printer Friendly
The Free Library
19,595,263 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Andrx Comments on Barron's Article.


Business Editors/High-Tech, Health & Medical Writers

FORT LAUDERDALE Fort Lauderdale (lô`dərdāl), residential, commercial, and resort city (1990 pop. 149,377), seat of Broward co., SE Fla., on the Atlantic coast; settled around a fort built (c.1837) in the Seminole War, inc. 1911. , Fla.--(BUSINESS WIRE)--March 11, 2002

ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today commented on the article that appeared in the March 11, 2002 edition of "Barron's". Written by William Alpert, the article correctly notes that Andrx and Biovail Corporation have engaged in a "long-running war over Andrx's intent to market a competing version of Biovail's...blood pressure drug Tiazac(R)." While the article then purports to cite many facts, it is clear that the author did not confirm the accuracy of those facts or substantiate To establish the existence or truth of a particular fact through the use of competent evidence; to verify.

For example, an Eyewitness might be called by a party to a lawsuit to substantiate that party's testimony.
 his conclusions.

More significantly, the article inaccurately infers that the amount of amendments required to gain FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval of Andrx's generic controlled-release medications somehow evidences the existence of regulatory issues at Andrx. The author makes this conclusion based upon a comparison of the amount of amendments FDA required for 812 generics applications, with the higher amount required for 24 applications submitted by Andrx and the few other companies capable of gaining approval for controlled-release products. Andrx disagrees with this conclusion and believes that the additional amendments result from the fact, as stated in the article, that "controlled-release capsules and tablets are among the hardest drugs to make...to ensure that medicine trickles out at predicted levels."

Scott Lodin, Andrx Pharmaceuticals President and General Counsel for Andrx Corporation, commented: "Controlled-release products are complex, require more ingredients and more manufacturing steps, and are often more sensitive than other medications, and an amendment is often required whenever Andrx seeks to make changes in its ingredients, manufacturing equipment or manufacturing settings, and the processes by which its medications are to be tested. While Barron's cites those amendments as somehow evidencing a problem, we believe they demonstrate that, once the innovator's patent barriers are removed, we can successfully scale-up and bring our products to market. Because there are so few companies that can make a similar claim, our controlled-release products generally face less competition and yield higher sales and profits than other generic medications."

Elliot F. Hahn, Ph.D., Chief Executive Officer and President of Andrx, added, "Indeed, when citing our recent press release disclosing the favorable fa·vor·a·ble  
adj.
1. Advantageous; helpful: favorable winds.

2. Encouraging; propitious: a favorable diagnosis.

3.
 court ruling we received for our bioequivalent bi·o·e·quiv·a·lent
n.
A value indicating the rate at which a substance enters the bloodstream and becomes available to the body.
 version of Wellbutrin SR(R), the article states that "Andrx strangely noted that it wouldn't market the drug until it addressed `all of FDA's concerns'." While I question how Mr. Alpert has any basis at all to find it `strange' that we would acknowledge that FDA has not yet approved our application to market that product, I am pleased to advise that the concerns we referenced are deemed to be `minor' by the FDA itself, and for the most part relate to a particular testing methodology which should be employed for our product. Having now tested our product using a new methodology which FDA has itself endorsed, I reiterate re·it·er·ate  
tr.v. re·it·er·at·ed, re·it·er·at·ing, re·it·er·ates
To say or do again or repeatedly. See Synonyms at repeat.



re·it
 my earlier statement that `Andrx believes that it has addressed all of FDA's concerns and that FDA approval should be received by mid-year.'"

Dr. Hahn added. "I responded to Mr. Alpert's call within a day, but he was apparently more determined to state his conclusions than to check his facts to provide a balanced and accurate story. An obvious example of Mr. Alpert's claim that Tiazac is a `$80-million-a year' drug, when IMS (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
 data reveals that Tiazac sales in 2001 were in excess of $200 million. Had an unbiased reporter been interested in obtaining answers to Mr. Alpert's questions, I am sure that we would have read a very different article."

Andrx Corporation is a specialty pharmaceutical company engaged in the formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating.

American Law Institute Formulation
 and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies.

Forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality gen·er·al·i·ty  
n. pl. gen·er·al·i·ties
1. The state or quality of being general.

2. An observation or principle having general application; a generalization.

3.
 of the foregoing, words such as "may," "will," "to," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Mar 11, 2002
Words:744
Previous Article:Best Buy Turns to CCP global To Implement Ariba Spend Management Solution.
Next Article:Tangram Offers Merger, Acquisition and Divestiture Assistance.
Topics:



Related Articles
Andrx Comments On Prilosec ANDA Filing.
Andrx Announces Results of Alzheimer's Disease Clinical Study.
Correcting and Replacing Previous Alzheimer's Clinical Study Announcement, BW0368, FL-ANDRX.
[0] Andrx Announces Results of Alzheimer's Disease Clinical Study.
Andrx Comments On New Omeprazole Patents.
Andrx Issues Update On Its ANDA for Generic Prilosec.
Andrx CEO Resigns; Remains as Co-Chairman; Elliot Hahn, Ph.D., Andrx President, Appointed Interim CEO.
Andrx Receives FDA Approvable Letter for Altocor.
COHR INC. SUED OVER ACCOUNTING.
Andrx Issues Update on its Generic Tiazac ANDA.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles