Mylan Launches Generic Nexium® Delayed-Release Capsules

Aug 05, 2015, 13:13 ET from Mylan N.V.

HERTFORDSHIRE, England and PITTSBURGH, Aug. 5, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg, which is the generic version of AstraZeneca's Nexium®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older.

Mylan CEO Heather Bresch commented: "Mylan's launch of Esomeprazole Magnesium Delayed-release Capsules USP represents our continued commitment to expand access to high quality medicine, and we're pleased to provide patients with another affordable treatment option. We look forward to continue delivering on our mission to set new standards in healthcare by expanding our broad portfolio of products in the U.S. and around the world."   

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, had U.S. sales of approximately $5.2 billion for the 12 months ending June 30, 2015, according to IMS Health.

Currently, Mylan has 268 ANDAs pending FDA approval representing $101.3 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. 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 around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products and 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; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; 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.

SOURCE Mylan N.V.



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