Roche and the pan-Canadian Pharmaceutical Alliance (pCPA) Complete Negotiations for Multiple Sclerosis Treatment, OCREVUS® (ocrelizumab), for both RRMS and PPMS

MISSISSAUGA, ON, March 19, 2019 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent regarding OCREVUS® (ocrelizumab) for the first-line treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease (defined by clinical and imaging features), and for the management of adult patients with early primary progressive multiple sclerosis (PPMS) (as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity).1 The pCPA is a body set up by the provinces and territories to jointly negotiate terms of public drug plan listings with pharmaceutical companies.

Thirteen of 16 jurisdictions signed on to the pCPA Letter of Intent to list OCREVUS, including: Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia, New Brunswick, Prince Edward Island, Newfoundland & Labrador, Yukon, Non-Insured Health Benefits (NIHB), Correctional Services Canada (CSC), and Veterans Affairs Canada (VAC). Roche Canada will continue to work across the country with the remaining jurisdictions to ensure public funding is available for all eligible patients.

"We are thrilled to have completed negotiations with the pCPA as the first step in allowing public funding in Canada for the first and only approved treatment for PPMS, the most severe and debilitating form of the disease, as well as a new way to target and reduce relapses and disease progression in people living with RRMS," says Ilona Torontali, Vice President, Access, Roche Canada. "Now that we have completed these negotiations, Roche Canada can begin working with each of the 13 jurisdictions to ensure that OCREVUS is available through each of the provincial public formularies."

The efficacy and safety of OCREVUS were evaluated in the pivotal phase III OPERA I & II (RRMS) and ORATORIO (PPMS) studies.

The most frequently reported adverse drug reactions (ADRs) were infusion related reactions (IRRs) and respiratory tract infections. In the OPERA and ORATORIO studies, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal edema, nausea, and tachycardia. The incidence of IRRs was highest during Dose 1, infusion 1 (27.5 per cent) and decreased with subsequent doses to <10 per cent at Dose 4. A greater proportion of people living with MS in each group experienced IRRs with the first infusion of each dose compared with the second infusion of that dose. The majority of IRRs were mild to moderate.2

About OCREVUS
OCREVUS is a humanized monoclonal antibody. Monoclonal antibodies are proteins, which bind to a unique site (called an antigen) on cells. OCREVUS binds to an antigen, called CD20, which is present at high levels on certain B cells of your immune system. OCREVUS works on your immune system so that it may not attack your nervous system. OCREVUS is administered by intravenous infusion (IV) every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as a single 600 mg infusion.3

About Multiple Sclerosis
MS is an autoimmune disease affecting the central nervous system, which is primarily made up of the brain and spinal cord. It attacks the nerves' protective covering (myelin), often damaging it and causing inflammation. Without myelin, nerve impulses cannot to be transmitted through nerve fibres, leading to unpredictable and often debilitating symptoms such as weakness, fatigue, and vision problems.4

Today, there are approximately 77,000 Canadians living with MS5, and RRMS is the most common form. RRMS is characterized by clearly defined attacks of new or increasing neurological symptoms. These attacks, known as relapses or exacerbations, are followed by periods of partial or complete recovery (remissions). During a recovery period, all symptoms may disappear, or some symptoms may continue and become permanent.6

PPMS is a debilitating form of MS, which results in difficulty walking – a sign of spinal cord disease, as well as brain and spinal cord atrophy (or shrinkage). Unlike other forms of MS such as RRMS, where there may be periods of remission between attacks, PPMS is a deteriorating form of the disease characterized by steadily worsening neurological function without periods of relapse and remission.7

About Roche
Headquartered in Basel, Switzerland, Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Roche Canada was founded in 1931. The company employs over 1,000 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

About Roche In Neuroscience
Neuroscience is a major focus of research and development at Roche. The company's goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer's disease, spinal muscular atrophy, Parkinson's disease, and autism.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2019; Hoffmann-La Roche Limited

REFERENCES

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1

OCREVUS® (ocrelizumab) Product Monograph. February 2018

2

OCREVUS® (ocrelizumab) Product Monograph. February 2018.

3

OCREVUSÒ (ocrelizumab) Product Monograph. February 2018.

4

Multiple Sclerosis Society of Canada. What is MS.

https://mssociety.ca/about-ms/what-is-ms. Last accessed March 11, 2019

5

Multiple Sclerosis Society of Canada. About MS.

https://mssociety.ca/about-ms/what-is-ms. Last accessed March 11, 2019

6

National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS).

http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Last accessed March 11, 2019.

7

Multiple Sclerosis Society of Canada. Managing Multiple Sclerosis.

https://mssociety.ca/managing-ms/living-with-ms/progressive-ms. Last accessed March 11, 2019.

SOURCE Roche Canada

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