Nabi Biopharmaceuticals Announce Settlement of Litigation

Nabi Biopharma announced that they have settled the patent infringement case against Roxane Lab w.r.t PhosLo® GelCaps. PhosLo® consists of the mineral calcium acetate. It is an orally given phosphate binder used in patients with End Stage Renal Disease (ESRD). PhosLo® was owned by Nabi Biopharmaceuticals until late 2006 when it and its related assests was sold to the US subsidiary of Fresenius Medical Care. From November 14, 2006 Nabi stopped distributing PhosLo®.
The settlement between Fresenius Medical Care Holdings, Roxane Lab and Nabi was made to the mutual satisfaction of all parties and was reviewed and accepted by the U.S. District Court of the Southern District of Ohio.
Nabi filed this lawsuit on September 27, 2005 under the Hatch-Waxman Act in response to a Paragraph IV Certification letter submitted by Roxane to the Company concerning Roxane's filing of an Abbreviated New Drug Application (ANDA) with the USFDA to market a generic version of the Company's PhosLo GelCaps. Nabi filed the lawsuit on the basis that Roxane Laboratories' submission of its ANDA and its proposed generic product infringed a patent held by the Company. On November 12, 2006, Nabi completed the sale of PhosLo and related intellectual property to Fresenius USA Manufacturing, Inc. While Fresenius assumed primary responsibility for the intellectual property dispute, Nabi remained subject to a counterclaim by Roxane that alleged violations of antitrust law and, therefore, responsible for defense costs and for any liability arising from the counterclaim. As a result of this settlement, Nabi is not required to pay any sums to the other parties