IVAX to Proceed to Phase II Study of Its Soft Corticosteroid BNP-166 for Crohn's Disease.

Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--March 21, 2002

IVAX Corporation (AMEX:IVX)(LSE:IVX.L) announced today it has successfully completed a Phase Ib study for Crohn's disease (regional ileitis), an inflammatory disease of the small bowel, of an oral form of its "soft corticosteroid", BNP-166. A multi-center Phase II study is anticipated to commence in the second quarter of this year.

This Phase Ib study was a double blind comparison of BNP-166 and prednisone. BNP-166 (up to 10 mg) or prednisone (5 mg) was administered twice daily to healthy male volunteers for 14 days and the results were calculated after the completion and unblinding of the study. At doses of up to 10 mg twice daily, BNP-166 did not cause any suppression of the hypophyseal-pituitary-adrenal (HPA) axis, a major side effect of corticosteroids. In contrast, a low dose of the commonly administered corticosteroid, prednisone (5 mg twice daily) caused marked suppression of the HPA axis. In earlier animal trials, BNP-166 was shown to be at least 10-times as potent as prednisone. Pharmacokinetic data generated in this study confirm that the drug is converted to the predicted inactive metabolites following absorption.

BNP-166 is one of a larger class of "soft corticosteroids" being developed at IVAX for inflammatory disorders of the gastrointestinal tract, asthma, and allergic disorders of the eye and skin. BNP-166 is designed to deliver active drug to inflamed portions of the gastrointestinal tract in patients with inflammatory bowel disease (IBD) such as regional ileitis (Crohn's disease) and ulcerative colitis. Unlike conventional corticosteroids, BNP-166 undergoes rapid conversion to well characterized inactive metabolites when absorbed into the blood stream, a process that reduces the likelihood of side effects of systemic exposure to corticosteroids.

IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and international markets.

Copies of this and other news releases may be obtained free of charge from IVAX' web site at http://www.ivax.com. Shareholders and prospective investors can register to automatically receive the company's press releases via email at http://www.ivax.com/ComNewsv2.htm.

This press release contains certain forward-looking statements regarding product development efforts and product performance and other non-historical facts which are being are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that cannot be predicted or quantified and, consequentially, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, that Phase II clinical trials for BNP-166 and IVAX' other products under development may not be commenced or completed on a timely basis or at all, may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that BNP-166 may not have superior effectiveness and fewer side effects than currently available products; that IVAX' patents pertaining to BNP-166 may be invalidated or may otherwise not succeed in preventing other similar and/or competitive products; and that others may develop product formulations that are superior to the IVAX formulation.. In addition to the risk factors set forth above, IVAX' forward looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, trade buying patterns, patent positions and litigation, among other things. For further details and discussion of these and other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.