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Impact, Tolmar in Generic Topical Pact

Impax to commercialize as many as nine products in 2012

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Impax Laboratories and Tolmar will collaborate on a multiproduct agreement for the development, supply and distribution of generic topical prescription drug products. Tolmar will supply as many as nine currently approved and marketed products, and Impax’s generics division, Global Pharmaceuticals, will commercialize these products following a short transition period.

According to Wolters Kluwer Health, total U.S. brand and generic sales of these nine multi-source products were approximately $378 million in the 12 months ended May 2012. The agreement also includes two additional generic topical prescription drug products, of which one is currently in development and one is a first-to-file ANDA pending approval at the FDA.

Impax will pay Tolmar $21 million upon the closing and as much as $25 million in milestone payments, if certain commercialization and ANDA approval targets are met. In addition, Impax will pay Tolmar a profit share for each product commercialized. The transaction is expected to be accretive to Impax’s earnings per share (EPS) in 2012.

“We are excited to further enhance our relationship with Tolmar on these products as we continue to diversify our generic product portfolio,” said Larry Hsu, Ph.D., president and chief executive officer of Impax. “This represents Global Pharmaceuticals first opportunity to commercialize alternative dosage form products alongside our existing portfolio of tablets and capsules. Our business development activities will continue to focus on delivering growth from high-value products, technologies, and businesses in complementary dosage forms.”

Mike Duncan, chief executive officer of Tolmar, added, “We are very excited about this expansion of our already strong relationship with Impax Laboratories. This agreement is aligned with our long term strategy and we firmly believe that Impax Laboratories is the right partner for these products. From its inception in 2006, Tolmar has been developing and introducing new products to the market through strategic partnerships. We look forward to working with Impax Laboratories as we continue to expand our product offerings in the generic dermatology space.”

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