Mylan To Market Generic Arixta, Launches Osteoporosis Med
By Lori Clapper
It was a busy week for Mylan, with its announcement that its subsidiary Mylan Ireland Limited will acquire the U.S. commercialization, marketing, and intellectual property rights of Aspen Global’s Arixtra (fondaparinux sodium) Injection and the authorized generic version. Both are used to treat deep vein thrombosis (DVT), which could lead to the development of pulmonary embolism (PE) following complications in various surgery situations.
According to the agreement, Mylan will pay Aspen $225 million upon completion of the transaction, with $75 million being held in escrow until certain conditions of the deal are met. All other terms of the agreement have not been disclosed, according to a company announcement.
This move will bring upwards of an additional $100 million into Mylan’s bank account, as Arixtra and its generic version saw $18.8 million and $95.3 million, respectively, in U.S. sales alone in the past year, according to IMS Health.
DVT/PE is a serious health concern that is estimated to affect up to 600,000 people in the U.S.,” Mylan CEO Heather Bresch commented. "The addition of Arixtra is an attractive opportunity to broaden the range of therapeutic categories we market in the U.S., in both the hospital and retail settings, and bolster our growing portfolio of complex injectables to better meet our customers' needs."
This move comes shortly after the company officially added a new generic to its portfolio, launching its version of Hoffmann-La Roche’s Boniva injection. The U.S. FDA gave final approval to Mylan for its Abbreviated New Drug Application (ANDA) for the new drug product designed to treat osteoporosis in postmenopausal women.
The Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes raked in roughly $18.4 million in the U.S. for the year ending June 30, 2014, IMS Health calculated.
Mylan presently has 288 ANDAs up for FDA approval, which represents $110.3 billion in annual brand sales. Of those ANDAs, forty-two of them are potential first-to-file opportunities and could bring in up to $27.5 billion in annual brand sales.