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Andrx Enters into Alliance for Generic Lovenox with Amphastar.


FORT LAUDERDALE, Fla. -- Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or the "Company") announced today that it has entered into an agreement to obtain certain exclusive marketing rights for both strengths of Amphastar Pharmaceuticals, Inc.'s ("Amphastar") proposed generic version of Lovenox(R), Aventis Pharmaceuticals, Inc.'s ("Aventis") enoxaparin sodium enoxaparin sodium Warning - High-alert drug!

Clexane (UK), Lovenox 3.

Pharmacologic class: Low-molecular-weight heparin

Therapeutic class: Anticoagulant

 injectable product. Amphastar submitted its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  ("ANDA ANDA
abbr.
abbreviated new drug application
") for generic Lovenox to the 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.
 in March 2003. Amphastar's product is the subject of a 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.  lawsuit filed by Aventis, and the 30-month stay imposed by law, which runs through February 2006. Lovenox is indicated for the prevention of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  in certain patients undergoing abdominal surgery and knee or hip replacement surgery, and for the prevention of certain cardiovascular events. According to IMS Health data, Lovenox generated total 2004 U.S. sales of approximately $1.5 billion.

Andrx's marketing rights generally extend to the U.S. retail pharmacy market, representing approximately 30% of total Lovenox sales. To obtain such rights, Andrx paid $4.5 million upon execution of the agreement and will make an additional $5.5 million payment to Amphastar once certain milestones relating to the product are achieved, including obtaining FDA marketing approval and a favorable resolution of the pending patent 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.
. In exchange, Andrx will receive up to 50% of the net profits, as defined, generated from sales of Amphastar's product in the retail pharmacy market. Under certain specified conditions, Andrx has the right to receive a refund of the amounts it paid to Amphastar.

Larry Rosenthal, Andrx Pharmaceuticals, Inc. President stated, "This agreement allows Amphastar to utilize Andrx's generic sales, marketing and distribution capabilities for its generic Lovenox product and is part of our strategy to externally leverage Andrx's core capabilities, both domestically and internationally."

About Andrx Corporation:

We are a pharmaceutical company that:

--develops, manufactures and commercializes generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives Oral Contraceptives Definition

Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills.
;

--distributes pharmaceuticals, primarily generics, which have been commercialized by others, as well as our own, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices; and

--develops and manufactures pharmaceutical products for other pharmaceutical companies, including combination products and controlled-release formulations utilizing our patented technologies and formulation capabilities.

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 herein or which are otherwise made by or on behalf of the Company 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," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to, the approval of Amphastar's ANDA for generic Lovenox or the outcome of the litigation or commercial success of such product; the Company's dependence on a relatively small number of products; licensing revenues; the timing and outcome of litigation and future product launches; government regulation; competition; manufacturing capacities, safety issues, output, and our manufacturing and quality processes. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein.

This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:May 4, 2005
Words:593
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