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Teva Canada Announces the Launch of a Bioequivalent Generic Version of Gilenya®, Teva-Fingolimod Capsules for the treatment of Relapsing-Remitting Multiple Sclerosis (MS)

 - Currently Available in Canada -

TORONTO , Oct. 31, 2019 /CNW/ - Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd., announced the launch of PrTeva-Fingolimod 0.5 mg capsules, a Health Canada approved, bioequivalent generic version of PrGilenya® (fingolimod hydrochloride) in Canada.

Teva-Fingolimod_ENG (CNW Group/Teva Canada Limited)

PrTeva-Fingolimod (fingolimod hydrochloride) is indicated as monotherapy for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of physical disability. PrTeva-Fingolimod is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis.

"MS is known as 'Canada's disease' as our country has the highest prevalence in the world,i  with over 77,000 Canadians currently living with this chronic neurological conditionii," said Christine Poulin , Senior Vice President and General Manager, Teva Canada . "With the launch of PrTeva-Fingolimod, we are pleased to offer patients a cost-effective, bioequivalent treatment option to PrGilenya® and, through the Teva-Fingolimod Patient Care ProgramSM, individualized support and a seamless transition process from brand to generic."

Teva-Fingolimod Patient Care ProgramSM

The Teva-Fingolimod Patient Care ProgramSM is designed to support the patient journey for those taking PrTeva-Fingolimod. It will support patients who are moving from the brand (PrGilenya®) medication to Teva Canada's bioequivalent generic version (PrTeva-Fingolimod) and new patients who are starting fingolimod hydrochloride treatment for the first time.

Elements of the program include:

  • Patient Enrolment: Completed by the prescriber, pharmacy team or patient directly (enrolment form available here: www.TevaCanada.com/Fingolimod-Support)
  • First Dose Monitoring: Appointment coordination (required for new patients only, starting fingolimod hydrochloride treatment for the first time)
  • Financial Support: Trained Patient Care Specialists will help investigate coverage options and provide reimbursement navigation and co-pay support to enroled patients.

For additional information on this program, call 1-855-868-7622 or visit: www.TevaCanada.com/Fingolimod-Support

Fingolimod hydrochloride (brand: PrGilenya®) had annual sales of approximately $103 million in Canada , based on IQVIA sales data as of August 2019 . PrTeva-Fingolimod is available immediately to pharmacies across Canada. The launch of PrTeva-Fingolimod demonstrates Teva Canada's research and development capabilities and desire to continue to provide patients with a range of treatment options and resources.

About Multiple Sclerosis

MS is currently classified as an autoimmune disease of the central nervous system (brain, spinal cord). The disease attacks myelin, the protective covering of the nerves, causing inflammation and often damaging the myelin. Myelin is necessary for the transmission of nerve impulses through nerve fibres. MS is unpredictable and can cause symptoms such as extreme fatigue, lack of coordination, weakness, tingling, impaired sensation, vision problems, bladder problems, cognitive impairment and mood changes. Its effects can be physical, emotional and financial.iii It affects three times as many women as men and strikes people in the prime of their lives, as the average age of onset is 31.iv  Canada has one of the highest rates of multiple sclerosis (MS) in the world, with an average of 8 women and 3 men diagnosed with MS every day.v

MS is divided into several basic categories, depending on the pattern of the individual's disease. Relapsing remitting MS is a category characterized by unpredictable but clearly defined periods during which symptoms are apparent. These ''relapses" are also known as episodes, attacks, exacerbations, or flare-ups. Relapses can last for varying periods (from a few days to several months) and are followed by periods of recovery, or 'remission' during which many functions return. About 85% of people are diagnosed with this form of MS.vi

Helping People Live Better Days

At Teva, we care deeply about the wellbeing of the patients, caregivers and communities who rely on us. We serve 200 million people every day, with a promise to help them take better control of their health. From our role as a global leader in generic and brand-name medicines to the innovative solutions we create for our healthcare partners, we offer a unique perspective on health—here in Canada and around the world.

About Teva Canada Limited

Teva Canada Limited, headquartered in Toronto , has provided affordable healthcare solutions for over 50 years, with sales of more than $1 billion in 2018 and nearly 225,000 prescriptions filled with our products every dayvii. Originally Novopharm Limited, Teva Canada Limited specializes in the development, production and marketing of high-quality generic prescription pharmaceuticals and through our branded division, Teva Canada Innovation, focuses on a diverse line of innovative products in a variety of therapeutic areas. Teva Canada employs more than 1,000 professionals, markets over 385viii products in 1,000 SKUs in Canada and is a subsidiary of Teva Pharmaceutical Industries Ltd., the world's largest generic drug maker. For more information, visit: www.tevacanada.com

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people's lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com 



Source: St. Michael's Hospital – Newsroom – "St. Michael's Hospital announces plans to create world's leading treatment and research centre for multiple sclerosis, "Canada's disease" |http://www.stmichaelshospital.com/media/detail.php?source=hospital_news/2017/1122 - Accessed September 2019


Source: Government of Canada – Health - Publications – Diseases and conditions – Diseases - Multiple Sclerosis in Canada | https://www.canada.ca/en/public-health/services/chronic-diseases/multiple-sclerosis.html  - Accessed September 2019


Source: MS Society of Canada – About MS – What is MS? | https://mssociety.ca/about-ms/what-is-ms - Accessed September 2019


Source: St. Michael's Hospital – Newsroom – "St. Michael's Hospital announces plans to create world's leading treatment and research centre for multiple sclerosis, "Canada's disease" | http://www.stmichaelshospital.com/media/detail.php?source=hospital_news/2017/1122 - Accessed September 2019


Source: Government of Canada – Health - Publications – Diseases and conditions – Diseases - Multiple Sclerosis in Canada |https://www.canada.ca/en/public-health/services/publications/diseases-conditions/multiple-sclerosis-infographic.html - Accessed September 2019


Source: MS Society of Canada – About MS – What is MS? - Does everyone experience MS the same way? | https://mssociety.ca/about-ms/what-is-ms - Accessed September 2019


Source: IQVIA CDH & Compuscript MAT July 2019


Source: IQVIA CDH & Compuscript MAT July 2019


Teva Canada Limited (CNW Group/Teva Canada Limited)

SOURCE Teva Canada Limited

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