On Wednesday, Shares of Merck & Co., Inc (NYSE:MRK), lost -1.44% to $51.93.
Merck (MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. declared the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. BRENZYS is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older).
The approval of BRENZYS in Korea represents the first product approval under Merck’s partnership with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to assist address patient and healthcare system needs worldwide. Merck plans to launch BRENZYS in South Korea by the end of this year or early next year.
“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of BRENZYS in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our partnership with Merck.”
“The approval of BRENZYS in Korea is a key milestone in Merck’s longstanding commitment to improving access to important medicines,” said Dora Bibila, general manager, Merck Biosimilars. “We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of BRENZYS – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis.”
Merck & Co., Inc. provides health care solutions worldwide. The company offer therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, asthma, nasal allergy symptoms, allergic rhinitis, chronic hepatitis C virus, HIV-1 infection, fungal infections, intra-abdominal infections, hypertension, arthritis and pain, inflammatory, osteoporosis, male pattern hair loss, and fertility diseases.
Shares of Mylan NV (NASDAQ:MYL), declined -2.38% to $47.56, during its last trading session.
Mylan NV, declared the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, which is the generic version of Bayer’s Yasmin® Tablets. Mylan’s partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy.
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, had U.S. sales of about $137.6 million for the 12 months ending June 30, 2015, according to IMS Health. The immediate availability of this product represents Mylan’s thirteenth oral contraceptive launch in the U.S.
Presently, Mylan has 266 ANDAs pending FDA approval representing $99.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
Mylan N.V., through its auxiliaries, develops, licenses, manufactures, markets, and distributes generic, branded generic, and specialty pharmaceuticals worldwide. The company provides generic or branded generic pharmaceutical products in tablet, capsule, injectable, or transdermal patch forms, in addition to active pharmaceutical ingredients (APIs).
Finally, Citizens Financial Group Inc (NYSE:CFG), ended its last trade with -0.93% loss, and closed at $24.40.
Citizens Bank declared that John Bahnken has been named President, Wealth Administration, effective October 5, 2015. Bahnken, a financial services veteran with more than 30 years of wealth administration, investment administration and banking experience, joins Citizens from Bank of the West/BNP Paribas and formerly held executive leadership roles at firms counting Bank of America and FleetBoston Financial.
Bahnken will report to Brad Conner, Vice Chairman and Head of Consumer Banking. He succeeds Mike Millard, who is retiring from Citizens after leading Wealth Administration for 10 years.
“As we continue to grow our wealth administration business and to assist more and more Citizens Bank customers plan for retirement and other long-term financial objectives, we are very happy to declare John Bahnken as our new Head of Wealth Administration,” Conner said. “John brings tremendous experience from some of the most-respected wealth administration and investment firms in the country and will provide key leadership for all of our wealth administration businesses. I also want to thank Mike Millard for his leadership of this business for 10 years and wish him all the best in life’s next chapter.”
Citizens Financial Group, Inc. operates as the bank holding company for Citizens Bank, N.A. and Citizens Bank of Pennsylvania that provide retail and commercial banking products and services in the United States.
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