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Luitpold and Fresenius Medical Care Sign Agreement for Renal Drug

July 9, 2008

Luitpold Pharmaceuticals and its subsidiary, American Regent, have entered into a definitive agreement with Fresenius Medical Care for an exclusive US manufacturing and distribution sublicense for Venofer for the end stage renal disease (Stage V) patient population.

As part of this 10 year agreement (with two additional five year renewal terms), Luitpold will continue to contract manufacture these products for Fresenius Medical Care. The transaction involves the payment of royalties by Fresenius Medical Care to Luitpold over the lifetime of the agreement, and Luitpold’s payment of royalties to Vifor Pharma of St Gallen, Switzerland, which supplies the active pharmaceutical ingredient to Luitpold. Luitpold, through its subsidiary American Regent, will continue to sell Venofer for use in treating chronic kidney disease patients not yet on dialysis.

The agreement additionally includes a similar sublicense for the next generation of IV iron products for the US and Canada known as Injectafer (ferric carboxymaltose injection), which is expected to enhance the treatment of anemia in this same patient population through the application of innovative drug administration techniques.

Venofer a preparation of elemental iron in sucrose, is the only first line treatment option approved by the FDA for the intravenous treatment of both dialysis and non-dialysis chronic kidney disease (CKD) patients with iron deficiency anemia.

The transaction is subject to customary closing conditions including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Act. The company anticipates closing this transaction in 2008.




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