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Andrx Settles Federal Trade Commission Dispute Over Cardizem CD Stipulation.


Business Editors

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 2, 2001

ANDRX CORPORATION - Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) announced today that the Federal Trade Commission ("FTC FTC

See Federal Trade Commission (FTC).
") has issued for public comment a proposed Agreement Containing Consent Order ("Consent Agreement") resolving the FTC's proceedings concerning Andrx' 1997 Stipulation and Agreement with Aventis (formerly Hoechst Marion Roussel, Inc. ("HMR HMR Hazardous Materials Regulations
HMR Human Resources
HMR Home Meal Replacement
HMR Hamrun (postal locality, Malta)
HMR Hôpital Maisonneuve-Rosemont (Montréal, Canada) 
")). Under the Consent Agreement, "which is for settlement purposes only," Andrx denies any allegation of wrongdoing wrong·do·er  
n.
One who does wrong, especially morally or ethically.



wrongdo
 and is not subject to any fines, penalities, or other monetary obligation. Instead, Andrx would agree to refrain from taking certain future actions described in a consent decree A settlement of a lawsuit or criminal case in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit.

A consent decree is a settlement that is contained in a court order.
 and order that accompanies the Consent Agreement.

When the FTC initiated its administrative complaint against Andrx and HMR in March 2000, it did so, it said, in order to "develop...a full factual record to help shape further the appropriate parameters of permissable conduct" given the various conflicting policies balanced by the Hatch-Waxman Act. In its Analysis to Aid Public Comment ("Analysis") issued by the FTC together with the Consent Agreement, the FTC said that its proposed resolution with Andrx and HMR "strikes an appropriate balance, on a prospective basis, between the legitimate interests of (Andrx and HMR) and the Commission's concerns with the possible competitive effects of agreements between" New Drug Application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") holders and ANDA ANDA
abbr.
abbreviated new drug application
 first filers. The Analysis explains that, "by not imposing any broad prohibitions on (Andrx' and HMR's) ability to compete, the Order maintains HMR's incentive to develop and sell new drug products and Andrx' incentive to develop and sell generic products that do not infringe valid intellectual property rights held by others" and "preserves Andrx' ability to decide for itself whether to market a product in the face of a claim of patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. ." Following the FTC's multi-year factual investigation and legal analysis of the Stipulation, the Analysis states that "based on the FTC's investigation, it does not appear that there was any delay in the entry into the market of a generic version of Cardizem(R) CD by Andrx or any potential manufacturer, or that the conduct or agreement at issue delayed consumer access to a generic version of Cardizem(R) CD."

Andrx President, Elliot F. Hahn, Ph.D., stated: "Andrx has steadfastly maintained that the Stipulation was procompetitive and that it allowed us to market Cartia XT(R), Andrx' 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 Cardizem(R) CD, well before it could have absent the Stipulation. We are obviously delighted with the resolution of the FTC matter and look forward to continuing to cooperate with that agency to police abuses of Hatch-Waxman that negatively affect consumers."

Full texts of the settlement are available on the Andrx (www.andrx.com) and FTC (www.FTC.gov) web sites. In summary, the proposed consent decree would prohibit Andrx, when it is the first filed ANDA applicant, from (a) entering into future agreements with NDA holders that include provisions prohibiting Andrx from relinquishing its Hatch-Waxman right of exclusivity or from selling the product, unless the product is or would be the subject of a patent infringement claim, or (b) from entering into certain types of stand-still arrangements during litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 without court or FTC approval. Andrx believes that the settlement, which will remain in place for 10 years, will not affect any stated or planned future conduct by Andrx.

Forward-looking statements (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 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 are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx Group is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation's filings with the Securities and Exchange Commission, including Andrx Corporation's Annual Report on Form 10-K for the year ended December 31, 1999.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 2, 2001
Words:696
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