PITTSBURGH—Mylan Ireland Limited, a subsidiary of Mylan Inc., has inked an agreement with Aspen Global Incorporated to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra (fondaparinux sodium) Injection and the authorized generic of Arixtra. The anticoagulant is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip fracture surgery, including extended prophylaxis, hip replacement surgery, knee replacement surgery or abdominal surgery who are at risk for thromboembolic complications. Mylan is currently marketing Arixtra in the United States in accordance with an interim distribution arrangement with Aspen, while Apotex is marketing the authorized generic, which will also be transitioning to Mylan Institutional by the end of the year.
Per the terms of the agreement, Aspen will receive $225 million once the transaction is complete, with an additional $75 million to be held in escrow and released once certain conditions are satisfied. Aspen will provide Mylan with Arixtra and its authorized generic, subject to certain terms and conditions. The transaction is subject to regulatory clearances, and is expected to be immediately accretive to Mylan’s adjusted earnings.
“DVT/PE is a serious health concern that is estimated to affect up to 600,000 people in the U.S. 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,” Heather Bresch, CEO of Mylan, said in a press release.
Aspen noted in a press release that it “took the decision to enter into this transaction as a consequence of the Group’s current absence of sales representatives in the U.S., which prevents it from being able to optimize the commercial performance of the fondaparinux products in that country. AGI has retained all of its remaining rights to the intellectual property and to the commercialization of Arixtra worldwide other than in the U.S.” The company adds that “There are opportunities to grow Arixtra and Fraxiparine, particularly in emerging markets.”
Aspen acquired the Arixtra and Fraxiparine/Fraxodi thrombolytic brands worldwide (excluding China, India and Pakistan) from GlaxoSmithKline for £505 million (approximately $820.2 million) last year, in a transaction that became effective on December 31, 2013. According to IMS Health, Arixtra and its authorized generic saw U.S. sales of roughly $18.8 million and $95.3 million respectively for the twelve-month period ending June 30, 2014.
DVT, as described by the National Heart, Lung and Blood Institute (NHLBI), is “a blood clot that forms in a vein deep in the body.” These clots “can break off and travel through the bloodstream. The loose clot is called an embolus. It can travel to an artery in the lungs and block blood flow. This condition is called pulmonary embolism.” The NHLBI notes that while deep vein clots can form elsewhere in the body, most form in the lower leg or thigh; furthermore, “blood clots in the thighs are more likely to break off and cause PE than blood clots in the lower legs or other parts of the body.”
