BMS Withdraws New York Complaint Against IVAX; IVAX Comments On Other Pending Litigation

Business Wire, Oct 18, 2000

Business Editors/Health & Medical Writers

MIAMI--(BUSINESS WIRE)--Oct. 18, 2000

IVAX Corporation (AMEX:IVX) said today that Bristol-Myers Squibb Company (BMS) has dismissed without prejudice its previously announced complaint filed against IVAX in the Federal District Court for the Southern District of New York for a declaratory judgment regarding a patent issued to American BioScience, Inc. (ABI) for a formulation of paclitaxel, the active ingredient in Taxol(R). The action had sought a judicial ruling as to whether the ABI patent should be listed in the FDA's Orange Book, thereby potentially blocking approval of generic paclitaxel products. Neil Flanzraich, president and vice chairman of IVAX, commented, "We are not surprised that Bristol-Myers has abandoned this lawsuit, given that it completely failed to serve its intended purpose of preventing the FDA from granting IVAX final marketing approval for its paclitaxel product. It was a bogus lawsuit from its inception, and should never have been filed to begin with."

IVAX also commented on another lawsuit pertaining to its generic paclitaxel approval announced by ABI yesterday. Neil Flanzraich, president and vice chairman of IVAX, stated, "This is exactly the same claim that was turned down flatly by the federal district court for Washington, D.C., and the appellate court, finding that American BioScience was unlikely to ever succeed on the merits of its claim. Unlike playgrounds, our judicial system does not permit such obvious `do-overs.' What American BioScience and Bristol-Myers are doing is clogging the courts with frivolous litigation in a feeble and hopeless attempt to prevent the introduction of generic paclitaxel. Between them, they have filed six lawsuits in four different states relating to the American BioScience patent and the approval of our paclitaxel product. Fortunately, the courts have refused to allow these tactics to succeed in preventing the launch of our product, and Bristol-Myers' voluntary withdrawal of one of these lawsuits is further evidence of its lack of merit. We are confident that this latest effort by American BioScience will be equally unsuccessful." As previously announced, IVAX plans to launch its paclitaxel product before the end of the month.

The "FDA" refers to the United States Food and Drug Administration, and the "Orange Book" is officially known as the FDA's list of Approved Drug Products with Therapeutic Equivalence Evaluations.

IVAX Corporation, headquartered in Miami, Fla., is a holding company with subsidiaries engaged in the research, development, manufacturing, and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products 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 that may affect IVAX' business and prospects, including the risks that IVAX may not be successful in the current paclitaxel-related litigation; that ABI may be successful in its action against the FDA; that IVAX' launch or commercialization of paclitaxel may be delayed or interfered with by legal or regulatory actions or for other reasons; 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 10KA and other filings with the Securities and Exchange Commission. Taxol(R) is a registered trademark of the Bristol-Myers Squibb Company.