Merck Canada Inc. to Enter New Area of Medicine with Biosimilars in Canada

Biosimilars to Offer More Options to Further Support the Canadian Health Care System

KIRKLAND, QC, Dec. 3, 2015 /CNW/ - As part of the previously-announced agreement between Merck & Co., Inc. and Samsung Bioepis Co., Ltd., Merck Canada Inc. announced today that it is preparing to bring to market a diversified portfolio of biosimilar medicines in Canada over the coming years. Biosimilars can play an important role in contributing to the sustainability of the healthcare system and generate savings, which could be applied towards increased access to innovative medicines.

Biosimilars, also known as Subsequent Entry Biologics (SEBs) in Canada, are biologic medicines that enter the market after a previously authorized version and, with demonstrated similarity to a reference biologic medicine¹, are intended to treat various diseases, such as cancer, rheumatoid arthritis, growth deficiencies, Crohn's, diabetes, or psoriasis. While originator biologics will continue to be important therapeutic options, biosimilars can provide Canadians with more, lower-priced treatment options.

Working Together to Establish a Landscape of Biosimilars in Canada
Reimbursement policies from public and private payers need to be adapted to help secure rapid access to biosimilars, while providing viable and sustainable conditions for their continued use. With the appropriate reimbursement conditions in place, the Canadian healthcare system will be able to benefit from the significant savings potential of these medicines.

Biologic drugs are one of Canada's fastest-growing segments in pharmaceutical spending, showing a 12.2% growth rate for the 12 months ending August 2014 while the total drug expenditures were up 3%. Over that same period of time, biologics sales accounted for $5.6B or 24% of the entire Canadian market for pharmaceuticals, and included four of the top five selling drugs in Canada.²

"I prescribe the medicine that is in the best interest of my patients, given their medical conditions and clinical needs," says Dr. Edward Keystone, a rheumatologist and director of the Rebecca MacDonald Centre for Arthritis and Autoimmune Disease at Mount Sinai Hospital in Toronto. "The question is whether public and private insurers will give priority to biosimilars. Should they choose not to, physicians will most likely continue to prescribe the originator biologics, being that these medicines are historically what they have been accustomed to, which would then limit the use of biosimilars in the long term and prevent the ability to lower drug costs."

Merck prides itself in bringing new medicines to Canadians. Its approach to biosimilars or any other medicine is motivated by a focus on patients. Merck remains committed to providing access support for its medicines. In collaboration with governments, private payers, industry, health care practitioners and stakeholders, Merck will work to establish an environment that will foster a viable biosimilars industry in Canada.

"Merck's core focus has always been to offer innovative medicines that address unmet medical needs. In today's complex and challenging environment, innovation can also include the identification of new solutions that can help sustain the healthcare system, while allowing the company to continue funding innovation for the many unmet needs that remain," said Bruno Mäder, Head of the Merck Biosimilars Business Unit in Canada. "We are actively mobilizing resources across Canada to support our Biosimilars unit, as we work to provide thousands of Canadian patients with access to effective treatment options at significantly lower prices."

About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside Canada and the United States. 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 about our operations in Canada, visit www.merck.ca.

Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2014 Annual Report on Form 10-K and the company's other filings with the

Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

^1		Health Canada. June 2010. GUIDANCE FOR SPONSORS: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Accessed November 6, 2015. Available at http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
^2		IMS Brogan, PharmaFocus 2018, MAT August 2014, Accessed Oct 28, 2014

SOURCE Merck Canada Inc.

Media contacts: Ani Armenian, Merck, [phone]; Investor Relations, Amy Klug, Merck, [phone]; Lisa Cancian, MacLAREN McCANN HEALTH, [phone]; Yannick Gayama, MacLAREN McCANN HEALTH, [phone]