Mylan Presents Equivalence Data on Glatiramer Acetate Compared to Copaxone® at American Academy of Neurology 70th Annual Meeting

Three posters highlight Mylan's rigorous Glatiramer Acetate development program

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Apr 21, 2018, 11:30 ET

HERTFORDSHIRE, England, and PITTSBURGH, April 21, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced three scientific abstracts from the Glatiramer Acetate development program will be presented at the American Academy of Neurology (AAN) 70^th Annual Meeting in Los Angeles, April 21-27. The data, available for the first time publicly, further supports the U.S. Food and Drug Administration's approval in October 2017 of Mylan's Abbreviated New Drug Applications for Glatiramer Acetate Injection 40 mg/mL and 20 mg/mL formulations.

Mylan's Head of Morgantown Research & Development Patrick Vallano commented, "We are excited to present at this year's American Academy of Neurology annual meeting Mylan's rigorous equivalence data that demonstrated sameness between Mylan's Glatiramer Acetate and Copaxone®. The three posters describe the testing and characterization analyses conducted to show comparability in fundamental chemistry, physiochemical properties and molecular pathways between the two products. We believe a world-renowned venue like AAN's annual meeting is the perfect opportunity for Mylan to showcase and discuss the strong science behind our Glatiramer Acetate."

Mylan's data will be presented during the following poster sessions at the meeting and later available in "Neurology," the official journal of AAN.

Abstract 3323: Demonstration of Equivalence of Generic Glatiramer Acetate (GA) Produced by Mylan to Copaxone®

April 22, 4 p.m. to 5:30 p.m. PST
Poster Session P1
Poster #361

Abstract 3177: Characterization and Comparison of the Gene Expression Profiles of Copaxone® and Mylan Glatiramer Acetate

April 22, 4 p.m. to 5:30 p.m. PST
Poster Session P1
Poster #376

Abstract 3183: Generation and Analysis of Human T Cell Lines Responsive to Glatiramer Acetate

April 26, 5:30 p.m. to 7 p.m. PST
Poster Session P5
Poster #363

Full session details and abstracts for the 2018 Scientific Sessions can be found at the American Academy of Neurology's website at www.aan.com.

About Mylan
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 more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

SOURCE Mylan N.V.