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Andrx Acquires U.S. Distribution Rights to Pfizer's Cardura XL; Will Expand Andrx's Brand Product Portfolio.


Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nov. 25, 2003

Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or "Company") today announced that it has expanded its brand product portfolio by entering into a supply and distribution agreement with Pfizer Inc ("Pfizer") regarding Pfizer's 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 ) for Cardura(R) XL, a sustained-release formulation of doxazosin mesylate dox·a·zo·sin mesylate
n.
An alpha-blocker drug used to treat hypertension and benign prostatic hyperplasia.


doxazosin mesylate
(doksā´zōsin mes´ilāt´),
n brand name:
, used to treat benign prostatic hyperplasia benign prostatic hyperplasia
n. Abbr. BPH
A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine.
 (BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
).

Filed in April 2001, the Company anticipates 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 Cardura XL in mid-2004. Under terms of the agreement, Andrx will pay a total of $35 million upon execution of the exclusive distribution agreement in the United States and upon FDA approval of the NDA with certain minimum claims. Andrx will market Cardura XL and purchase certain minimum quantities of Cardura XL from Pfizer for three years.

Richard J. Lane, Andrx's Chief Executive Officer, said, "Cardura XL represents a significant opportunity, both for Andrx and for people who suffer from the affects of BPH. We are eager to begin marketing the benefits of Cardura XL to both general practitioners and urologists, who can then make this important medicine available to their patients."

BPH is the most common benign neoplasm neoplasm or tumor, tissue composed of cells that grow in an abnormal way. Normal tissue is growth-limited, i.e., cell reproduction is equal to cell death.  (non-cancerous enlargement of the prostate gland) in men and its prevalence increases with age. According to empirical data, BPH is estimated to occur in 25%-50% of men in their 50s to early 60s, and in as many as 80% of men in their 70s and 80s. Bothersome and restrictive symptoms place a significant burden on the daily lives of men with BPH, and complications of severe BPH can be dangerous. Annual growth of the BPH market is estimated to be between 7% and 30%, but many patients are not treated. Aging but active baby-boomers are expected to increase the level of treatment, as they are likely to be less tolerant of the impact of BPH on the quality of their lives.

In connection with the addition of Cardura XL, Andrx is in the process of determining how to adjust the utilization and size of its brand sales force to more appropriately handle the brand products it intends to promote in 2004. Andrx's brand product portfolio currently includes Altocor(TM) (extended release lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with ) for hyperlipidemia hyperlipidemia /hy·per·lip·id·emia/ (-lip?i-de´me-ah) elevated concentrations of any or all of the lipids in the plasma, including hypertriglyceridemia, hypercholesterolemia, etc.  and, in 2004, is expected to include Fortamet(TM) (extended release metformin HCL) for type-2 diabetes (for which an FDA approvable letter has been received), both of which were developed by Andrx.

About Andrx Corporation:

Andrx Corporation develops and commercializes: 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.
 versions of controlled-release brand name pharmaceuticals, using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx also has distribution operations, which purchase primarily generic pharmaceuticals manufactured by third parties and sell them primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and, to a lesser extent, physicians' offices.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor 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 risk and uncertainties, including but not limited to, the Company's dependence on a relatively small number of products, licensing revenues, the timing and outcome of 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.
 and future product launches, when or whether the Pfizer NDA for Cardura XL will receive FDA final marketing approval or be launched, government regulation, competition, and manufacturing results. 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 are also available on the Internet at: http://www.andrx.com.
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Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Nov 25, 2003
Words:717
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