Federal court blocks American BioScience 'duplicative' suit against FDA

The United States District Court in Washington, DC has told American BioScience Inc. (ABI), a small private company with business relationships with Bristol-Myers Squibb (Taxol's original developer), that American Bio could not pursue a suit to prevent IVAX from marketing a generic form of Taxol (paclitaxel). The DC court held that the California action was duplicative of the litigation that ABI had previously filed in the DC court, which sought to rescind IVAX's approval for its generic version of Taxol. In October, the DC court specifically determined that ABI was unlikely to succeed in its lawsuit and denied the company's motion for a preliminary injunction ordering the FDA to revoke its approval of IVAX's generic version of Taxol. The DC court also prospectively enjoined ABI from filing any additional duplicative lawsuits.

"We are obviously pleased with the decision. In effect, the Court told ABI, 'Enough is enough!'" said Neil Flanzraich, president and vice chairman of IVAX.

During the month of October, IVAX won several court decisions filed by Bristol-Myers Squibb and ABI. At stake is Taxol's $1.2 billion (1998) stake as the number-one drug in the growing oncology market. Bristol-Myers' Taxol business is itself controversial, since much of the discovery and development work on the drug was conducted at the National Institutes of Health.

For more information, contact Tabitha H. Licea of IVAX Corp. at 305-575-6043.

Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online and Drug Discovery Online
Email: adepalma@vertical.net