Merck & Co. plans to sell the NDAs for purified corticotropin gel and corticotropin-zinc hydroxide to ANI Pharmaceuticals for $75 million cash and a percentage of future net sales, ANI said today.

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 ACTH with zinc hydroxide for repository action.

The products are approved for various diseases including multiple sclerosis, rheumatic disorders, dermatologic diseases, and a variety of collagen, ophthalmic, respiratory diseases, as well as allergic and edematous states.

“This acquisition is intended to enable us to compete in a one billion dollar branded market,” ANI president and CEO Arthur S. Przybyl said in a statement.

Przybyl cited sales of Malinckrodt’s H.P. Acthar® gel repository corticotropin injection. Acthar racked up $763.1 million in net sales during the first three quarters of that company’s fiscal year ending June 26, plus $122.9 million in Mallinckrodt’s fiscal fourth quarter ending September 26, 2014—the first quarter to include sales of Acthar since it was acquired as part of Mallinckrodt’s purchase of Questcor Pharmaceuticals, a deal completed in August 2014 for $5.8 billion.

Headquartered in Baudette, MN, ANI is a specialty pharmaceutical company focused on developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The company's targeted areas of product development currently include narcotics, oncolytics, hormones, and steroids, as well as complex formulations involving extended release and combination products.

Robert W. Schrepfer, ANI’s vp, business development, said the deal with Merck “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,” Schrepfer added.

ANI said it expects to carry out its acquisition through one or more foreign subsidiaries to be created for that and other purposes, such as manufacturing products and/or providing other ancillary services. The buyer anticipates the subsidiaries will enable it to reduce its overall tax rate for its operations.

ANI said its acquisition was being funded through cash on hand, and was subject to closing conditions.








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