EMD Serono Continues Leadership Role in Product Integrity by Launching Product Tracking Program and Check My Meds™ Smartphone App

- Program launched in advance of U.S. Drug Supply Chain Security Act deadlines

- Check My Meds TM product verification app now available for download for U.S. patients

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Dec 10, 2014, 08:00 ET

ROCKLAND, Mass., Dec. 10, 2014 /PRNewswire/ -- EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, announced that it has serialized all of its major brands in the U.S., which helps patients and physicians to authenticate the company's medicines at the unit level. This new serialization initiative builds on the company's track record of product integrity and will launch in advance of requirements set forth in new legislation for pharmaceutical companies to serialize their prescription drug products at the unit level by 2017.

EMD logo.

"EMD Serono has been a long-standing leader in product integrity and patient safety, and we believe that every biopharmaceutical company has a responsibility to work toward a counterfeit-free drug supply in the U.S.," said Paris Panayiotopoulos, President and Managing Director of EMD Serono. "I am proud that EMD Serono is well ahead of the U.S. Food and Drug Administration's (FDA) upcoming requirement that drug companies include a unique serial number on each package of drugs dispensed by 2017."

In conjunction with completing its serialization initiative, EMD Serono also launched Check My Meds^TM, a smartphone app that will put the power to verify medicines in the hands of EMD Serono's patients. The app is now available for free download in English on iOS and Android mobile phones.

"Counterfeit and compromised drugs have breached the U.S. drug supply numerous times over the past decade," said Allan Coukell, senior director for health programs at The Pew Charitable Trusts. "By serializing medicines three years in advance of statutory requirements to do so, EMD Serono has taken steps to increase security of the drug supply chain and protect patients."

Through the serialization initiative, all major EMD Serono brands, which include therapies for multiple sclerosis (MS), infertility, growth disorders and HIV-associated wasting, will have unique and randomized serial numbers that are generated and printed on each package during the production process. The Check My Meds^TM app allows patients to check this serial number to verify the authenticity of their medication, and also link to mobile sites for EMD Serono's industry-leading patient support and access programs, including MS LifeLines®, Fertility LifeLines®, The Axis Center® and Connections for Growth®.

As a subsidiary of Merck KGaA, Darmstadt, Germany, one of the largest and oldest global pharmaceutical and chemical companies, EMD Serono leveraged the resources and expertise of its global organization to complete this initiative in advance of requirements set forth by new legislation in the Drug Supply Chain Security Act (DSCSA), which was enacted on November 27, 2013. The requirements of the DSCSA are enforced by the FDA.

EMD Serono has been a pioneer in serialization advocacy and action since 2002 with the implementation of its first secure distribution program.

About EMD Serono

EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading U.S. biopharmaceutical company focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

For more information, please visit www.emdserono.com

About Merck KGaA, Darmstadt, Germany

Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world's oldest pharmaceutical and chemical company – since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.

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SOURCE EMD Serono