Healthcare Industry News: thrombosis
News Release - September 10, 2014
Mylan to Acquire U.S. Rights to Arixtra(R) (fondaparinux sodium) Injection from AspenProvides Another Important and Highly Complex Injectable to Complement Mylan Institutional's Growing Portfolio in the U.S.
PITTSBURGH, Sept. 10, 2014 -- (Healthcare Sales & Marketing Network) -- Mylan Inc. (MYL) today announced that its subsidiary Mylan Ireland Limited has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra® (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated. Arixtra 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 already is selling Arixtra in the U.S. through an interim distribution arrangement with Aspen and Apotex is currently selling the AG of Arixtra, which will be transitioning to Mylan Institutional by year end.
Mylan CEO Heather Bresch commented, "DVT/PE is a serious health concern that is estimated to affect up to 600,000 people in the U.S.1 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."
Mylan will pay Aspen $225 million upon completion of the transaction. An additional $75 million will be held in escrow and released upon satisfaction of certain conditions. Aspen will supply Arixtra and the AG of Arixtra to Mylan, subject to certain terms and conditions. The transaction is subject to regulatory clearances. All other terms of the agreement remain confidential. The transaction will be immediately accretive to Mylan's adjusted earnings.
Arixtra and the AG of Arixtra had U.S. sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending June 30, 2014, according to IMS Health.
This press release includes statements that constitute "forward-looking statements," including with regard to the company's strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
1 Centers for Disease Control and Prevention. Deep Vein thrombosis (DVT) / Pulmonary Embolism (PE) — Blood Clot Forming in a Vein, Data & Statistics. http://www.cdc.gov/ncbddd/dvt/data.html. Accessed on Sept. 2, 2014.
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