EMD Serono Appoints Craig Millian Senior Vice President, Neurology and Immunology

ROCKLAND, Mass., Sept. 16, 2016 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced the appointment of Craig Millian as Senior Vice President, Neurology and Immunology. Mr. Millian most recently served as Senior Vice President, Head of US Fertility and Endocrinology at EMD Serono. In his new role, he will lead the strategic direction of the Company's US Neurology and Immunology franchise.

"Craig is a dynamic leader with a proven track record of success," said Gary Zieziula, President and Managing Director of EMD Serono. "He has been instrumental in expanding our leadership in Fertility and Endocrinology, and he will bring that passion and expertise to the Neurology and Immunology business, furthering our commitment to improving care for people living with multiple sclerosis and other conditions as we advance our pipeline."

Mr. Millian joined EMD Serono in 2010 to lead the Fertility and Endocrinology marketing team. He previously served as Vice President, Commercial at Vertex, where he helped design and build the commercial infrastructure, organizational capabilities and go-to-market plans in advance of launching the Vertex product pipeline. Prior to Vertex, he held commercial leadership roles at Pfizer and Sanofi. Mr. Millian holds an MBA from New York University and a degree in Finance from the University of Pennsylvania.

Drew Young, who previously served as Senior Vice President, Neurology and Immunology for EMD Serono, has recently been appointed to a new position within Merck KGaA, Darmstadt, Germany. He will serve as General Manager and Managing Director, Merck KGaA, Darmstadt, Germany, Biopharma, Australia & New Zealand, effective September 1, 2016. Mr. Young joined EMD Serono in June 2014 and had a positive impact on the company's neurology and immunology performance.

EMD Serono's neurology franchise includes Rebif (interferon beta-1a), the #1 prescribed interferon for patients with relapsing forms of MS new to therapy and switching therapy combined in the US.ⁱ Rebif has a well-established safety profile with more than 20 years of accrued clinical trial and patient experience. Since its approval in 2002, more than 130,000 people have chosen Rebif to treat their relapsing MS. In addition to providing this important treatment option, EMD Serono offers comprehensive support to patients through MS LifeLines. For more than 14 years, this award-winning patient support service has provided round-the-clock education and support for people living with relapsing MS.

The company also has a pipeline of products it is investigating in the immunology and neurology space.

About Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established.

Important Safety Information
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.

Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.  Monitor liver function tests and patients for signs and symptoms of hepatic injury.  Consider discontinuing Rebif if hepatic injury occurs.

Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.

In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.

Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.

Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.

The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.

There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Rebif full prescribing information is available at http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version=

About EMD Serono, Inc.
EMD Serono is the biopharma business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products 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 oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

www.emdserono.com

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck KGaA, Darmstadt, Germany, generated sales of € 12.8 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the Merck KGaA, Darmstadt, Germany, name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

ⁱ IMS NPA Market Dynamics Data, May 2016-July 2016 (rolling 3 months/New To Brand Rx). New To Brand Rx is defined as the sum of patients who are switching from another therapy (including patients who stopped a DMT for greater than 30 days, then restarted on a different DMT) as well as patients who have not received a prescription in at least the prior 12 months.

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