ROCKVILLE, Md., April 3, 2008 (PRIME NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced today a settlement of the patent infringement case against Roxane Laboratories that involved Nabi's former product, PhosLo(r) (calcium acetate) GelCaps. The settlement between Fresenius Medical Care Holdings, Inc., Roxane Laboratories, Inc. 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. The terms of the settlement are confidential and the court dismissed the case with prejudice and without costs.
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 U.S. Food and Drug Administration 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.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(r) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and StaphVAX(r) (Staphylococcus aureus Polysaccharide Conjugate Vaccine), a vaccine designed to prevent the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements including statements about the strategic alternatives process, development of our product candidates, and clinical trials and studies. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, anticipations or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: successfully pursue strategic and other alternatives; obtain successful clinical trial results; receive PhosLo milestone and royalty proceeds; successfully partner with third parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; realize anticipated cost saving; attract and maintain the human and financial resources to bring to market products in development; depend upon third parties to manufacture our products; achieve approval and market acceptance of our products; enter into and maintain arrangements with third parties to market and sell our products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 filed with the Securities and Exchange Commission.