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EMD Serono Announces Civil Settlement

ROCKLAND, Mass.--(BUSINESS WIRE)--May 4, 2011 - EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it has resolved a civil matter led by the U.S. Attorney's office in Maryland concerning fees paid to physicians for speaking and consulting on Rebif® (interferon beta-1a). The investigation is now resolved.

Under the terms of the settlement, EMD Serono agreed to make a payment of $44.3 million and amend its Corporate Integrity Agreement (CIA) to include additional controls. EMD Serono cooperated in good faith throughout the process that led to the settlement. The investigation has now been resolved. EMD Serono has not, as a part of this settlement, admitted any improper conduct.

As previously reported, a financial provision was taken for this settlement in 2009. The provision is sufficient and the settlement will not impact 2011 earnings.

“It is important to note that the settlement contains no claims that unnecessary prescriptions for Rebif were written, no allegations of patient harm and no admission of fault by the company,” said Thomas G. Gunning, Senior Vice President and General Counsel, EMD Serono, Inc. “EMD Serono is committed to operating its business with the highest legal, compliance and ethical standards. When questions arise, we discuss them openly with the government and resolve them in a way that is satisfactory to both the company and the government.”

About EMD Serono, Inc.

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, with Rebif® (interferon beta-1a), as well as in endocrinology, with Saizen® (somatropin (rDNA origin) for injection), Serostim® (somatropin (rDNA origin) for injection) and EGRIFTATM (tesamorelin for injection). EMD Serono is a leader in reproductive health, with Gonal-f® (follitropin alfa for injection), Luveris® (lutropin alfa for injection) and Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection). In addition, EMD Serono is growing its expertise and presence in the area of oncology, with more than 10 projects currently in development. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1100 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

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About Merck KGaA

Merck is a global pharmaceutical and chemical company with total revenues of ‚¬ 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 68 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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Contact: EMD Serono, Inc.
Renee Connolly, 781-681-2340


Posted: May 2011