Impax Laboratories, Inc. and Northern Colorado based, Tolmar, Inc. will collaborate on a multiproduct agreement for the development, supply and distribution of generic topical prescription drug products. As part of the development, distribution and supply agreement, Tolmar, will supply up to 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 US 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 Abbreviated New Drug Application (ANDA) pending approval at the US Food and Drug Agency (FDA).
Under the terms of the Agreement, Impax will pay Tolmar, $21 million upon the closing and up to $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, PhD, president and CEO of Impax Laboratories. “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, CEO of Tolmar, said, “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.”
Approved ANDA product includes: Betamethasone Dipropionate Cream (Augmented) 0.05 per cent, Calcipotriene Topical Solution 0.005 per cent, Fluticasone Propionate Cream 0.05 per cent (not currently marketed), Imiquimod Cream 5 per cent , Lidocaine 2.5 per cent / Prilocaine Cream 2.5 per cent, Metronidazole Topical Gel 0.75 per cent, Mometasone Furoate Lotion 0.1 per cent, Mometasone Furoate Ointment 0.1 per cent and Mometasone Furoate Cream 0.1 per cent.
Pending and Under Development ANDA products: Diclofenac Gel 3 per cent (generic to Solaraze) – According to Wolters Kluwer Health, US sales of Solaraze 3 per cent gel were approximately $131 million in the 12 months ended May 2012; One ANDA topical product under development.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.
Tolmar, Inc. is a pharmaceutical research, development, manufacturing and commercial operations company. Tolmar develops and manufacturers both proprietary and generic pharmaceutical products.