ANI gains 7 products from Amneal-Impax merger
ANI Pharmaceuticals will be adding to its product portfolio as a result of the recently approved merger of Amneal Pharmaceuticals and Impax Labs. The Baudette, Minn.-based company has acquired seven products that the companies were required to divest as part of the Federal Trade Commission’s approval of the deal.
The cash transaction will add to the company’s portfolio five approved generics and one pipeline product, as well as the licensing, supplying and distribution agreement for diclofenac-misoprostol DR tablets, which are awaiting regulatory approval. The company said that the market for the seven products sits at roughly $1.7 billion annually, according to IQVIA data.
“The acquisition will align strongly with ANI's strategic focus to grow our generic pipeline, expand our commercial portfolio, and leverage our U.S. based manufacturing plants. Importantly, the acquisition includes several products that compete in exciting markets including aspirin/dipyridamole ER Capsules and methylphenidate ER tablets,” ANI president and CEO Arthur Przybyl said. “Following the close of the transaction, ANI will immediately begin the work necessary to pursue the launch of these approved ANDAs, which represent considerable commercial opportunities. Finally, we are pleased to have successfully participated in this FTC-related acquisition and hope to leverage this experience to pursue similar opportunities in the future.”
The three commercialized products are generics of Vytorin (ezetimibe-simvastatin tablets), Felbatol (felbamate tablets) and Norpramin (desipramine tablets). Awaiting commercialization are the generic Aggrenox (aspirin/extended-release dipyridamole tablets) and attention-deficit/hyperactivity disorder drug methylphenidate hydrochloride extended-release tablets.
ANI will secure a supply agreement with the option to receive generic Aggrenox capsules from Amneal starting in late 2019, with distribution rights to extend through early 2021. This option could obligate ANI to make a milestone payment to Amneal depending on the number of generics on the market when it launches.
ANI also will acquire certain manufacturing equipment that is installed at a third-party contract site manufacturing the methylphenidate HCl ER tablets.
The cash transaction will add to the company’s portfolio five approved generics and one pipeline product, as well as the licensing, supplying and distribution agreement for diclofenac-misoprostol DR tablets, which are awaiting regulatory approval. The company said that the market for the seven products sits at roughly $1.7 billion annually, according to IQVIA data.
“The acquisition will align strongly with ANI's strategic focus to grow our generic pipeline, expand our commercial portfolio, and leverage our U.S. based manufacturing plants. Importantly, the acquisition includes several products that compete in exciting markets including aspirin/dipyridamole ER Capsules and methylphenidate ER tablets,” ANI president and CEO Arthur Przybyl said. “Following the close of the transaction, ANI will immediately begin the work necessary to pursue the launch of these approved ANDAs, which represent considerable commercial opportunities. Finally, we are pleased to have successfully participated in this FTC-related acquisition and hope to leverage this experience to pursue similar opportunities in the future.”
The three commercialized products are generics of Vytorin (ezetimibe-simvastatin tablets), Felbatol (felbamate tablets) and Norpramin (desipramine tablets). Awaiting commercialization are the generic Aggrenox (aspirin/extended-release dipyridamole tablets) and attention-deficit/hyperactivity disorder drug methylphenidate hydrochloride extended-release tablets.
ANI will secure a supply agreement with the option to receive generic Aggrenox capsules from Amneal starting in late 2019, with distribution rights to extend through early 2021. This option could obligate ANI to make a milestone payment to Amneal depending on the number of generics on the market when it launches.
ANI also will acquire certain manufacturing equipment that is installed at a third-party contract site manufacturing the methylphenidate HCl ER tablets.