IVAX Comments On New Taxol Related Patent Listing by Bristol-Myers Squibb

Business Wire, August 15, 2000

Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--Aug. 15, 2000

IVAX Corporation (AMEX:IVX) announced that it has just learned that Bristol-Myers Squibb (BMS) has listed a newly-issued Taxol(R)-related patent in the United States Food and Drug Administration's (FDA) List Of Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the "Orange Book." According to information received by IVAX, BMS listed in the Orange Book U.S. Patent No. 6,096,331 (the "'331 patent") which is entitled "Methods and Compositions Useful For Administration of Chemotherapeutic Agents." Additionally, according to the information received by IVAX, the patent is not owned by BMS but by a third party.

Ordinarily, once a patent has been listed in the Orange Book and, assuming that the listing is proper, a generic applicant is required to file with the FDA a certification explaining the applicant's position with respect to whether the patent is valid or whether it will be infringed by the manufacture, use or sale of the applicant's proposed generic drug. Once such a certification has been filed and notice has been given to the patent holder, the patent holder has 45 days in which to file a patent infringement suit against the generic applicant, and the pendency of such suit could block the FDA from granting final approval for the generic application for up to 30 months.

In the case of Taxol, IVAX has already certified against the patents previously listed by BMS in the Orange Book, was sued by BMS, obtained an order invalidating the patents (which order is currently on appeal), and the 30-month stay of FDA approval as it related to that patent litigation has expired. Should the propriety of this latest patent listing be upheld and should another patent lawsuit be filed against IVAX, IVAX' approval for paclitaxel may be further delayed while the patent issues are litigated.

Given the circumstances under which IVAX believes the '331 patent was submitted for inclusion in the Orange Book (which IVAX believes to be suspect), IVAX is evaluating the situation and has not reached any conclusive determination whether this new listing will result in delay of approval for its paclitaxel product. IVAX' Vice Chairman and President, Neil Flanzraich, commented, "While we have just received this information and are still evaluating it, our preliminary review leads us to believe that this is just another improper effort by BMS to thwart generic competition, and we are confident that we will be able to defeat this latest scheme just as we have defeated BMS' previous efforts."

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect IVAX' business and prospects, including the risks that IVAX may not be successful in challenging BMS's listing of the '331 patent, that the validity and/or enforceability of the '331 patent may be upheld, that FDA approval of IVAX' pending ANDA for paclitaxel may not be obtained or may be delayed, limited or qualified, that the pending appeal of the prior patent litigation instituted against IVAX may not be resolved favorably to IVAX, and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on form 10K and other filings with the Securities and Exchange Commission. Taxol(R) is a registered trademark of the Bristol-Myers Squibb Company.