ANI Pharmaceuticals has agreed to buy Merck’s NDAs for purified corticotropin gel and corticotropin zinc hydroxide for $75m in cash and a percentage of future net sales.
Corticotropin gel is a purified corticotropin (ACTH) in a sterile solution of gelatin for prolonged activity, while corticotropin-zinc hydroxide is a sterile aqueous suspension of ACTH with zinc hydroxide for repository action.
These products are approved for various disease states such as multiple sclerosis, rheumatic disorders, dermatologic diseases, and a variety of collagen, ophthalmic, respiratory diseases as well as allergic and edematous states.
According to ANI, the current annual US market for these acquired products is around $1bn as evidenced by sales of HP Acthar gel marketed by Mallinckrodt Pharmaceuticals.
ANI Pharmaceuticals president and CEO Arthur Przybyl said: "This acquisition is intended to enable us to compete in a $1bn branded market alongside HP Acthar gel. We are confident in our ability to re-commercialise these products."
The transaction is being funded through cash, and is subject to certain closing conditions.
Under the deal, ANI has determined that these assets will be acquired by a foreign subsidiary to achieve more favourable tax treatment for the company.
ANI Pharmaceuticals Business Development vice-president Robert Schrepfer said: "This represents a transformational opportunity for ANI that remains consistent with our strategy of acquiring and re-commercialising 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."
ANI focuses on developing, manufacturing, and marketing branded and generic prescription pharmaceuticals and its targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.