Health Canada Approves Merck's STROMECTOLtm (ivermectin) for the Treatment of Intestinal Strongyloidiasis and Onchocerciasis

? Ivermectin, a treatment for potentially devastating tropical parasitic infections, and the subject of a Nobel Prize, is on the World Health Organization's List of Essential Medicines^1,2
? The product's availability is expected in November 2018

KIRKLAND, QC, Sept. 11, 2018 /CNW Telbec/ - Merck Canada Inc., known as MSD outside Canada and the United States, today announced the Health Canada approval of STROMECTOLtm (ivermectin), indicated for the treatment of intestinal strongyloidiasis and onchocerciasis, potentially devastating tropical parasitic infections.³

The approval comes as global rates of migration and travel put growing numbers of Canadians at risk of parasitic infection.⁴ Intestinal strongyloidiasis, a roundworm, is caused by Strongyloides stercoralis⁵, while onchocerciasis, commonly known as river blindness, is caused by Onchocerca volvulus. Both conditions are traced to tropical and subtropical regions; strongyloidiasis has also been traced to countries with temperate climates.⁶  Intestinal strongyloidiasis is acquired through direct contact with contaminated soil during agricultural, domestic and recreational activities, while onchocerciasis is acquired through insect bites.⁶

Canadians at risk of intestinal strongyloidiasis include both travellers to, and immigrants from, endemic regions.⁴ Because patients may only experience symptoms decades after they were initially infected, it can be difficult to diagnose.⁴

Current immigration and travel trends suggest that the incidence of strongyloidiasis could increase in Canada. Depending on country of origin, intestinal strongyloidiasis could affect up to 77% of some existing immigrants and refugees in Canada.⁴ Rates of intestinal strongyloidiasis are as high as 60% in tropical and sub-tropical countries with a climate and socioeconomic structure that are conducive to the transmission of the parasite.⁷

"Both intestinal strongyloidiasis and onchocerciasis have particular challenges related to diagnosis and treatment. Patients could either show no symptoms, or experience symptoms that do not lead clinicians to suspect a parasitic infection, including non-specific manifestations such as a rash, hives, abdominal pain and unintentional weight loss. The difficulties in diagnosis are further complicated by the fact that patients may not experience symptoms until many years after coming into contact with the parasite, and many clinicians may not be familiar with, or have easy access to, the relevant tests," said Dr. Michael Libman, MD, Director of the Centre for Tropical Diseases at McGill University. "However, if an infection persists for long enough, or the patient becomes immunocompromised, they could experience life-altering or life-threatening complications."

"We recognize that STROMECTOLtm is globally considered the standard-of-care with over 20 years of real-world experience, and that there is an unmet medical need in Canada. As a committed partner in health, Merck Canada Inc. is proud to provide a therapeutic choice, where previously treatment options were limited," said Anna Van Acker, President and Managing Director, Merck Canada Inc. "Having STROMECTOLtm now routinely available reinforces our ongoing commitment of improving the lives of Canadian patients."

About STROMECTOLtm (Ivermectin)

To consult the Canadian product monograph for complete prescribing information including contraindications, warnings, precautions, adverse reactions, interactions, dosing and condition of clinical use, please click here.³

About Merck

For over a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. 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 health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. 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; the company'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 the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company 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 the company's 2017 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).

STROMECTOLtm is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.

SOURCE Merck Canada Inc.