ANI Pharmaceuticals, a Baudette, Minnesota-headquartered pharmaceutical company, has agreed to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals, a Bridgewater, New Jersey-based generic-drug manufacturer, and Impax Laboratories, a Hayward, California-based specialty pharmaceutical company focused on controlled-release and specialty generics, for an undisclosed cash consideration.

The transaction is the result of a divestiture process mandated by the US Federal Trade Commission in connection with Amneal Pharmaceutical’s proposed business combination with Impax Laboratories. The two companies announced an agreement to merge in October 2017. The parties expect to close the asset transaction in early May 2018.

Upon closing the transaction, ANI will acquire a product portfolio consisting of five approved generic abbreviated new drug applications (ANDAs) and one pipeline product, erythromycin IR tablets, an antibiotic. ANI will also acquire a license, supply, and distribution agreement for a second pipeline product, diclofenac–misoprostol DR tablets, a combination medicine used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers, with a pending ANDA. The combined current annual US market for these seven products is approximately $1.7 billion, according to ANI based on information from IQVIA (formerly QuintilesIMS).

Currently three of the five approved products are commercialized: ezetimibe–simvastatin tablets, an anti-cholesterol drug; felbamate tablets, an antiepileptic; and desipramine tablets, an antidepressant. Following the close of the transaction, ANI says it will begin shipping these products to customers immediately. Two generic products are approved but not yet commercialized are aspirin/dipyridamole ER capsules, a drug to reduce the risk of stroke, and methylphenidate HCl ER tablets, a drug to treat attention deficit hyperactivity disorder. These products will be manufactured and supplied to ANI under multi-year supply agreements with Amneal, Impax, or pre-existing third-party contract manufacturers under agreements that will be assigned to ANI. ANI says it intends to immediately commence efforts to tech transfer the manufacturing of the acquired ANDA for aspirin/dipyridamole ER capsules to the company’s Baudette, Minnesota manufacturing facility.

As part of the transaction, ANI will secure a supply agreement with the option to receive generic aspirin/dipyridamole ER Capsules from Amneal Pharmaceuticals beginning in late 2019 with a right to distribute the product in the US market through early 2021. If ANI exercises this option, it may be obligated to make a milestone payment upon launch depending on the number of generic products in the market at the time of launch.

In addition, ANI will acquire certain manufacturing equipment currently installed at a third-party contract manufacturing site for the manufacture of methylphenidate HCl ER Tablets.

Source: ANI Pharmaceuticals