Merck Announces Samsung Bioepis Will Present New Biosimilars Data at the 2015 ACR/ARHP Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that Samsung Bioepis will present new Phase 3 clinical data for three investigational immunology biosimilar candidates at the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) 2015 Annual Meeting in San Francisco, Nov. 7-11.

Merck and Samsung Bioepis have a collaborative agreement to develop and commercialize biosimilar candidates in immunology, oncology and diabetes. These products have been designed to help meet the growing needs of patients and healthcare systems worldwide. In September, SB4 was approved by the Ministry of Food and Drug Safety in Korea, representing the first biosimilar product approval for Samsung Bioepis. Under Merck’s partnership with Samsung Bioepis, MSD will market SB4 in Korea under the brand name BRENZYS™ (etanercept).

“Patients living with rheumatoid arthritis and other chronic inflammatory diseases are faced with many challenges,” said Dora Bibila, general manager, Merck Biosimilars. “Through our partnership with Samsung Bioepis, Merck is committed to commercializing biosimilar alternatives to existing biologic therapies, and we are excited by the opportunity to expand patient access to effective and more affordable treatment options.”

The following Samsung Bioepis data presentations are part of the official ACR program. Abstracts are available online through the ACR website at www.acrannualmeeting.org.

SB4 Enbrel (etanercept) data at ACR

Abstract # 2055 – Oral Presentation: A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 52-week Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars; Location: West – First Floor

SB2 Remicade (infliximab) data at ACR

Abstract # 2056 – Oral Presentation: A Randomized, Double-Blind, Phase III Study Comparing SB2, an Infliximab Biosimilar, to the Infliximab Reference Product (Remicade) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 54-Week Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars; Location: West – First Floor

SB5 Humira (adalimumab) data at ACR

Abstract # 8L – Late-Breaking Poster Presentation: A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 24-Week Results; Tuesday, Nov. 10, 9:00 – 11:00 a.m. PST; Session Title: ACR Late-Breaking Abstract Poster Presentations; Location: South – Halls B-C (Poster Hall)

About the Merck and Samsung Bioepis collaboration

Merck and Samsung Bioepis announced in February 2013 a collaboration to develop and commercialize in certain partnered territories multiple biosimilar candidates. In February 2014, the two companies expanded the collaboration to include MK-1293, an insulin glargine biosimilar candidate currently in Phase 3 clinical development for the treatment of patients with type 1 and type 2 diabetes. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration, except for MK-1293, which Merck will continue to develop and manufacture. Merck will be responsible in its partnered territories for commercialization of all approved products resulting from the collaboration.

The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase 3 development [Merck partnered territories]:

• SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]
• SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]
• SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]
• SB3 Herceptin (trastuzumab) [worldwide]
• MK-1293 Lantus (insulin glargine) [worldwide]

Regulatory filings for each of these five biosimilar candidates are expected to occur in the Merck partnered territories in the 2015-2016 timeframe.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

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