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Jun 8, 2015

Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy Seretide® Evohaler® (Salmeterol Xinafoate/Fluticasone Propionate) Under the Brand Name Sirdupla™ in the UK

Mylan becomes the first company to market a generic version of the UK's number one prescribed long-acting beta2-agonist + inhaled corticosteroid pressurized metered-dose inhaler asthma therapy[1],[2]

HERTFORDSHIRE, England, and PITTSBURGH, June 8, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced that it has launched the first bioequivalent alternative to GlaxoSmithKline's Seretide® Evohaler® (salmeterol xinafoate/fluticasone propionate) under the brand name Sirdupla™ in the UK.[1] Sirdupla is a pressurized metered-dose inhaler (pMDI) and is indicated to help treat or prevent symptoms of asthma in adults 18 years of age and older.[3],[4] The product is being manufactured by 3M Drug Delivery Systems.

The UK has one of the highest rates of asthma in Europe, affecting one in five households, and, on average, three asthma patients in the UK die every day from the condition.[5] With 5.4 million people suffering from asthma in the UK, the condition costs the National Health Service (NHS) £1 billion (1.53 billion USD) annually.[5]

Mylan President Rajiv Malik said, "Mylan is excited to be the first company to offer adult asthma patients in the UK the generic version of Seretide Evohaler, delivering on our mission to increase access to high quality medicine. Sirdupla represents a significant advancement for the company that both strengthens our respiratory portfolio and pipeline and further demonstrates our ability to successfully execute on one of our key strategic growth drivers."

Mylan Europe President Jacek Glinka added, "The launch of Mylan's Sirdupla broadens patient access to an important treatment option and offers a familiar pMDI device experience to UK asthma sufferers. Asthma is a widespread illness in the UK and we are committed to contributing to ease this burden to both patients and the NHS."

"3M will fill, assemble and package Sirdupla at 3M's manufacturing facility in Loughborough, UK. By partnering with Mylan, 3M has taken an important step forward in the generics space. This partnership combines 3M's expertise in inhalation drug development and manufacturing with Mylan's leadership position in the global generics market, including expertise in commercializing complex respiratory products," said Cindy Kent, President and General Manager – 3M Drug Delivery Systems.

Sirdupla is a daily maintenance pressurized metered-dose inhaler that offers the same ease of use that patients expect from their asthma therapy. It is available in 125/25 mcg and 250/25 mcg with 120 doses.

In line with the provisions of Article 106 of Directive 2010/84/EU, all of our Summary of Product Characteristics and Product Information Leaflets can be accessed on the website of the MHRA (http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm). For the identification of Mylan documents please use the Product Licence (PL) number.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products, manufacturing 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; risks associated with international operations; 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.

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 around 1,400 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 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 or mylan.co.uk

About 3M Drug Delivery Systems 
3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop and manufacture complex pharmaceutical products using 3M's inhalation, transdermal or microneedle drug delivery technology. 3M offers a full range of feasibility, development and manufacturing capabilities to help bring products to market. Regulatory expertise, quality assurance, operations, marketed product support and other in-house resources are available for each step of the development and commercialization process. For more information, please visit www.3M.com/dds or call 1-800-643-8086.

About 3M 
At 3M, we apply science in collaborative ways to improve lives daily. With $32 billion in sales, our 90,000 employees connect with customers all around the world. Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M or @3MNewsroom.

[1] Data on file, Mylan.

[2] IMS MAT. February 2015.

[3] Sirdupla 125/25mcg Summary of Product Characteristics. May 2015.

[4] Sirdupla 250/25mcg Summary of Product Characteristics. May 2015.

[5] Asthma UK. Asthma facts and FAQs. http://www.asthma.org.uk/asthma-facts-and-statistics Accessed on April 30, 2015.

Seretide® and Evohaler®  are registered trademarks of Glaxo Group Limited.

SOURCE Mylan N.V.




Last Updated  04/08/2017