Impax, TOLMAR sign development, distribution agreement

As a part of the agreement, TOLMAR will supply up to nine currently approved and marketed products while Global Pharmaceuticals, Impax’s generics division, will commercialize these products following a short transition period.

Two additional generic topical prescription drug products, one of which is at present in development and the other one is a first-to-file abbreviated new drug application (ANDA) pending approval at the FDA, are also included in the agreement.

Impax president and CEO Larry Hsu said, "This represents Global Pharmaceuticals first opportunity to commercialize alternative dosage form products alongside our existing portfolio of tablets and capsules."

TOLMAR will receive $21m upon the closing and up to $25m in milestone payments, if certain commercialization and ANDA approval targets are met, from Impax.

TOLMAR is also eligible to receive a profit share for each product commercialized. The transaction is expected to be accretive to Impax’s earnings per share in 2012.

Approved ANDA products included in the agreement are Betamethasone Dipropionate Cream 0.05%, Calcipotriene Topical Solution 0.005%, Fluticasone Propionate Cream 0.05%, Imiquimod Cream 5%, Lidocaine 2.5% / Prilocaine Cream 2.5%, Metronidazole Topical Gel 0.75%, Mometasone Furoate Lotion 0.1%, Mometasone Furoate Ointment 0.1% and Mometasone Furoate Cream 0.1%.