PAR, UNIMED ANNOUNCE ANDROGEL SETTLEMENT

Par Pharmaceutical will be able to launch a version of Unimed Pharmaceuticals' testosterone-replacement product AndroGel more than four years before patent expiration under terms of a settlement the announced by the companies.

AndroGel (testosterone) is approved to replace testosterone in males who have a deficiency or absence of the hormone. The drug had retail sales of $261 million in 2005, according to www.drugtopics.com.

Unimed is a division of Solvay Pharmaceuticals, which under the agreement will grant Par a non-exclusive license to market, sell and distribute generic AndroGel, 1 percent strength, no later than February 2016. In return, Par admits the AndroGel patent is valid and enforceable and that Par infringes the patent. Solvay will also pay Par $60 million to co-promote AndroGel as well as future versions of the product for six years beginning in the first quarter of next year.

The patent suit was filed by Unimed and Laboratories Besins Iscovesco against Paddock Laboratories, which filed to market a generic version of AndroGel and which had licensed U.S. marketing rights for the generic product to Par. In a separate agreement, Par has acquired all rights from Paddock to manufacture generic AndroGel. The suit, which has been dismissed, was filed in the U.S. District Court for the Northern District of Georgia.