IVAX Corporation Receives Final Approval for European Marketing of PAXENE; European Commission Adopts Decision on Marketing Authorization

Business Wire, July 21, 1999

MIAMI--(BUSINESS WIRE)--July 21, 1999--

IVAX Corporation (AMEX:IVX) today announced that on July 19, the European Commission signed the Decision to grant a Marketing Authorization for its proprietary anti-cancer drug, PAXENE(R) (paclitaxel), in the 15 member-states of the European Union, for the treatment of AIDS-related Kaposi's sarcoma in patients who have failed prior liposomal anthracycline therapy. PAXENE(R) was developed by Baker Norton Pharmaceuticals, IVAX's U.S.-based proprietary research and development subsidiary; this European approval will be held by Norton Healthcare Limited, the company's subsidiary in the United Kingdom.

"This final marketing approval of PAXENE(R) by the Commission of the European Union is a fine achievement for our company," said Phillip Frost, M.D., Chairman and CEO of IVAX Corporation. "It allows for the market entry of PAXENE(R) into each of the EU's 15 member-states and adds impetus to our ongoing effort to develop and market an orally-administered system for paclitaxel. I applaud the efforts of our research and development teams in both the U.S. and the U.K. for their contributions to this milestone achievement."

IVAX also has an Abbreviated New Drug Application (ANDA) pending in the United States for a generic form of Taxol(R) (paclitaxel), for which the company expects six months of marketing exclusivity upon approval in the middle of 2000. The U.S. market for Taxol(R) is expected to exceed $1 billion in 1999. Paclitaxel was originally developed by the National Cancer Institute and licensed to Bristol-Myers Squibb in 1992. Bristol-Myers developed the product commercially and markets it in the U.S. and elsewhere under the trade name Taxol(R). Bristol-Myers' Taxol(R) is approved for the treatment of breast, ovarian, and non-small cell lung cancers.

In May, IVAX reported that its PAXORAL(R), an oral paclitaxel system developed by its Baker Norton Pharmaceuticals subsidiary, had shown encouraging preliminary results during a series of Phase I clinical trials. The results of these studies were presented at the last annual meeting of the American Society of Clinical Oncology in Atlanta. PAXORAL(R) may provide advantages over the injectable form in terms of patient convenience, reduced side effects, and possible improved efficacy for certain forms of cancer. Additionally, the clinical trials demonstrated that the company's oral system achieved blood levels of paclitaxel that are adequate for cancer chemotherapy.

IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacture, and marketing of branded and generic pharmaceuticals in the U.S. and international markets.

Except for the historical matters contained herein, statements in this press release are forward-looking and 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 which may affect IVAX's business and prospects, including the risk that IVAX may not successfully commercialize PAXENE(R), generic paclitaxel, or PAXORAL(R), and certain economic, competitive, governmental, technological and other factors discussed in the Company's filings with the Securities and Exchange Commission.