ANI Pharmaceuticals Inc. has acquired the NDAs for purified corticotropin gel and corticotropin zinc hydroxide from Merck for $75 million and a percentage of future net sales. ANI estimates that the current annual U.S. market for the products it is acquiring is approximately one billion dollars as evidenced by sales of H.P. Acthar gel marketed by Mallinckrodt Pharmaceuticals.

Corticotropin gel is a purified corticotropin (ACTH) in a sterile solution of gelatin for prolonged activity. Corticotropin-zinc hydroxide (sterile corticotropin zinc hydroxide suspension USP) is a sterile aqueous suspension of purified corticotropin (ACTH) with zinc hydroxide for repository action. The products are approved for various disease states including multiple sclerosis, rheumatic disorders, dermatologic diseases, and a variety of collagen, ophthalmic, respiratory diseases as well as allergic and edematous states.

As part of its acquisition strategy, ANI has determined to pursue the formation of one or more foreign subsidiaries to effect its acquisitions, manufacture products and/or provide other ancillary services. It is expected that this acquisition from Merck will be effected through one of such subsidiaries.

“This acquisition is intended to enable us to compete in a one billion dollar branded market alongside H.P. Acthar gel. We are confident in our ability to re-commercialize these products,” said Arthur Przybyl, president and chief executive officer, ANI Pharmaceuticals.

Robert Schrepfer, vice president of business development, ANI Pharmaceuticals, added, “This represents a transformational opportunity for ANI that remains consistent with our strategy of acquiring and re-commercializing previously approved products. We have added a unique and substantial opportunity to our expanding product pipeline and by establishing a new foreign platform we feel that ANI has set the stage for long-term growth both organically and through future acquisitions.”