Mitsubishi Tanabe Pharma Canada is Now Tanabe Pharma Canada

TORONTO, ON December 1, 2025 – Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced the change of its corporate name to Tanabe Pharma Canada, Inc. (TPC), effective immediately.

In July, MTPA’s parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), announced it would undergo a corporate name change to Tanabe Pharma Corporation (TP), effective December 1, 2025, following acquisition by Bain Capital, a leading global private investment firm. The new company name, “Tanabe Pharma,” reflects the steadfast commitment to further global growth as an R&D-driven pharmaceutical innovator and honouring the legacy of the former Tanabe Seiyaku, one of the world’s oldest pharmaceutical companies.

Though taking on a new name, TPC’s core values hold strong as the company remains dedicated to advancing science and creating hope for all underserved patient populations with complex needs.

“While our name is changing, our commitment to addressing the unmet needs of patients with serious, difficult-to-treat conditions remains unwavering,” said Andy Zylak, President, Tanabe Pharma Canada. “As Tanabe Pharma Canada, we will continue to build on our legacy of serving the ALS community and driving meaningful progress for Canadians living with debilitating diseases.”

TPC will continue to pursue a robust pipeline of products for hard-to-treat diseases, including neurodegenerative diseases, inflammatory, and metabolic conditions.

About Tanabe Pharma Canada, Inc.
Based in Toronto, Tanabe Pharma Canada, Inc. (TPC) is a wholly owned subsidiary of Tanabe Pharma America, Inc. (TPA), with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit https://ca.tanabe-pharma.com/.

About Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Tanabe Pharma America, Inc. (TPA) is a wholly-owned subsidiary of Tanabe Pharma Corporation (TP). It was established by TP to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit https://us.tanabe-pharma.com or follow us on X (formerly Twitter), Facebook and LinkedIn.

About Tanabe Pharma Corporation, Inc.
Tanabe Pharma Corporation (TP) is one of the oldest pharmaceutical companies in the world, founded in 1678. TP is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. TP sets the MISSION of “Creating hope for all facing illness.” To that end, TP is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. TP is focusing on “precision medicine” to provide drugs with high treatment satisfaction and additionally working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.tanabe-pharma.com/en/index.html.

Media inquiries:
Media_TPA.US@mb.tanabe-pharma.com

Mitsubishi Tanabe Pharma Canada, inc. Announces Publication Of Long-term Function And Survival Analysis Of RADICAVA^® Oral Suspension (edaravone) – Treated Patients With ALS

Results from this analysis were published in Muscle and Nerve

TORONTO, ON September 4, 2025 – Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced the publication of a retrospective analysis of patients living with amyotrophic lateral sclerosis (ALS) in Muscle and Nerve.¹ The analysis evaluated patients taking RADICAVA^® Oral Suspension (edaravone) compared with Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT)² historical placebo controls (patients who did not receive active investigational treatment, but may have received riluzole in their respective clinical trials), with evidence suggesting treatment with RADICAVA^® Oral Suspension decreased physical functional decline and offering insights into survival.

“ALS remains a fatal neurodegenerative disease with no cure, highlighting the critical need for treatments that can help slow functional decline,” said Dr. Angela Genge, Neurologist and Director, ALS Centre of Excellence for Research and Patient Care at The Neuro (Montreal Neurological Institute-Hospital). “This analysis adds to our growing understanding of the potential impact of RADICAVA^® Oral Suspension on disease progression in ALS, and provides valuable insights for healthcare professionals and Canadians impacted by this disease.”

The primary analysis, based on data from clinical studies MT-1186-A02/A04, evaluated long-term survival and functional outcomes of 78 propensity score-matched patients treated with RADICAVA^® Oral Suspension compared to 78 matched historical placebo controls from the PRO-ACT database.

The main statistical comparison was made between the Combined (FDA approved On/Off + investigational Once Daily) RADICAVA^® Oral Suspension versus PRO-ACT placebo group. The post-hoc analysis, based on data from clinical studies MT-1186-A01/A02/A03/A04, expanded the evaluation to a broader ALS population (n=210 RADICAVA^® Oral Suspension patients vs. 210 PRO-ACT placebo patients) to confirm robustness of the initial results.

Propensity score matching on 10 baseline variables was used to assess the impact of RADICAVA^® Oral Suspension on function and survival. The analysis showed evidence for a slowing of functional decline and improved survival outcomes with long-term RADICAVA^® Oral Suspension treatment versus PRO-ACT placebo group patients with ALS. The analysis also showed a smaller ALS Functional Rating Scale-Revised (ALSFRS-R) change from baseline, demonstrating a slower rate of functional decline observed over 48 weeks.

Results from this analysis are not generalizable and cannot be used to determine definitive conclusions about the effects of treatment. Results should be interpreted with caution.

This analysis was funded and conducted by MTPA. The full publication is titled, “Analysis of Long-term Function and Survival of Edaravone Oral Suspension-Treated Patients With Amyotrophic Lateral Sclerosis Using PRO-ACT Data as Historical Placebo Controls.”

Healthcare professionals may contact MTP-CA’s Medical Affairs department for more information.

About the PRO-ACT Database
PRO-ACT Dataset is the world’s largest ALS clinical trial data repository, compiling placebo and treatment-arm data from 36 phase II/III clinical trials and over 12,500 fully anonymized longitudinal Subject records funded by The ALS Therapy Alliance, Prize4Life, Inc., Northeast ALS Consortium (NEALS), Neurological Clinical Research Institute of Mass. General Hospital, ALS Finding A Cure, and The ALS Association. Neurological Clinical Research Institute of Mass. General Hospital created and maintained the PRO-ACT Dataset and serves as the coordinating center and data distributor of the PRO-ACT Dataset. Find out more at www.alsdata.org

About Studies MT-1186-A01/A02/A03/A04
Study MT-1186-A01 (NCT04165824) was a phase 3, global, multicenter, open-label study that evaluated the long-term safety and tolerability of the approved edaravone oral suspension 105 mg On/Off dosing regimen over 48 weeks, and Study MT-1186-A03 (NCT04577404) was its extension study, which provided up to 96 weeks of additional treatment. Study MT-1186-A02 (NCT04569084), a post-marketing commitment following the FDA approval of RADICAVA^® (edaravone), was a phase 3b, multicenter, double-blind, parallel-group, randomized study that evaluated whether investigational Once Daily edaravone oral suspension dosing was superior to the approved On/Off dosing based on Combined Assessment of Function and Survival, and assessed safety and tolerability over 48 weeks in patients with ALS; and Study MT-1186-A04 (NCT05151471) was its extension study, which provided up to 48 weeks of additional treatment.

In Study MT-1186-A02, a pre-planned futility analysis was conducted after 50% of the planned study population (N=190) reached 48 weeks, which assessed the study’s primary endpoint and the probability of the study results changing if all participants completed the 48-week study period. Through that interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that there was a low statistical probability for the investigational once-daily dosing regimen to show superiority to the current on/off dosing regimen as measured by the ALS Functional Rating Scale Revised (ALSFRS-R) score at study completion; therefore, study discontinuation was recommended by the IDMC.

About RADICAVA^® Oral Suspension (edaravone)
RADICAVA^® Oral Suspension is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period.

In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA^® was approved by the U.S. Food and Drug Administration (FDA) in May 2017. Marketing authorization for RADICAVA^® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021). In October 2024, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), announced the strategic business decision to discontinue RADICAVA^® IV infusion as fewer people living with ALS were still using RADICAVA^® IV. MTP-CA continues to market the oral formulation, RADICAVA^® Oral Suspension.

RADICAVA^® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA^® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit www.mt-pharma-ca.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance its pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹Takahashi F, Genge A, Hirai M, et al. Analysis of Long-Term Function and Survival of Edaravone Oral Suspension-Treated Patients With Amyotrophic Lateral Sclerosis Using PRO-ACT Data as Historical Placebo Controls. Muscle Nerve. Published online July 1, 2025. Doi:10.1002/mus.28462
²Pooled Resource Open-Access ALS Clinical Trials Database (PRO-ACT). Neurological Clinical Research Institute, Massachusetts General Hospital. Https://ncri1.partners.org/PROACT.

Mitsubishi Tanabe Pharma Canada, inc. To Discontinue RADICAVA^® IV (edaravone)

~MTP-CA continues to market the oral formulation, RADICAVA^® Oral Suspension~

TORONTO, ON, October 4, 2024 – Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced the strategic business decision to discontinue RADICAVA^® IV (edaravone), an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS) that was granted market authorization by Health Canada in October 2018. RADICAVA^® IV is not being discontinued for reasons of safety or effectiveness.

The distribution of RADICAVA^® IV will end as early as April 1, 2025, in Canada. Fewer people living with ALS are still using RADICAVA^® IV, and these patients should consult with their physician to determine how to best transition to an alternative treatment plan.

MTP-CA continues to market the oral formulation, RADICAVA^® Oral Suspension. The efficacy of RADICAVA^® Oral Suspension is based on a comparative bioavailability study in healthy subjects with RADICAVA^® Oral Suspension and RADICAVA^® IV. RADICAVA^® Oral Suspension demonstrated similar pharmacokinetics following oral administration or via feeding tube.¹ ²

For more information, including the full Product Monograph, please visit www.radicava.ca.

About RADICAVA^® IV and RADICAVA^® Oral Suspension (edaravone)

RADICAVA^® IV and RADICAVA^® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period.

In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA^® was approved by the U.S. Food and Drug Administration (FDA) in May 2017. Marketing authorization for RADICAVA^® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA^® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA^® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.

Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.

Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance its pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.

References:

¹RADICAVA^® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
²Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well-defined patients with amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512.

Mitsubishi Tanabe Pharma Canada Announces Oral Treatment Formulation For Amyotrophic Lateral Sclerosis (ALS) Now Eligible For Coverage Through Veteran Affairs Canada And Indigenous Services Canada

TORONTO, ON, December 13, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA) a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), announced today that RADICAVA® Oral Suspension (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS), a rapidly progressive, neurodegenerative disease¹, is now reimbursed by Veterans Affairs Canada (VAC) (Standard Benefit) and Indigenous Services Canada via the Non-Insured Health Benefits (NIHB) Program (Limited Use).

“We would like to thank Veterans Affairs Canada and Indigenous Services Canada for providing eligible people in Canada with access to this new ALS treatment formulation,” said Andrew Zylak, President, MTP-CA. “Including RADICAVA® Oral Suspension on these formularies is an important step to support those living with ALS who are eligible under the federal programs.”

According to the ALS Society of Canada, an estimated 3,000 Canadians currently are living with ALS², an incurable disease that affects the nerve cells in the brain and spinal cord.³ The majority of people with ALS die within two to five years of diagnosis.⁴ Symptoms of the condition can be subtle at first, and it can take an average of 21 months to receive a diagnosis of ALS in Canada.⁵,⁶

The efficacy of RADICAVA® Oral Suspension, is based on a bioavailability/bioequivalence study comparing it to RADICAVA® IV, which was authorized by Health Canada for the treatment of people with ALS in October 2018 and has shown in a pivotal trial to slow the loss of physical function in ALS by 33%.⁷,⁸

In addition to VAC and NIHB, RADICAVA® Oral Suspension is also covered under the Correctional Service of Canada federal drug plan, as well as the provincial drug plans in British Columbia, Alberta, Saskatchewan, Ontario, Quebec, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland and Labrador. To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension.

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About RADICAVA® IV and RADICAVA® Oral Suspension (edaravone)
RADICAVA® IV and RADICAVA® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA® was approved by the U.S. Food and Drug Administration (FDA) in May of 2017. Marketing authorization for RADICAVA® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² Benchmarking Survey, Federation of ALS Societies of Canada, 2016.
³ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
⁴ Mehta P, Kaye W, Raymond J, Punjani R, Larson T, Cohen J, et al. Prevalence of Amyotrophic Lateral Sclerosis – United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67:1285-1289.
⁵ Richards D, Morren JA, Pioro EP. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
⁶ Hodgkinson VL, Lounsberry J, Mirian A, Genge A, Benstead T, Briemberg H, et al. Provincial Differences in the Diagnosis and Care of Amyotrophic Lateral Sclerosis. Can J Neurol Sci. 2018;45:652-659.
⁷ RADICAVA® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
⁸ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505-512

Mitsubishi Tanabe Pharma Canada Celebrates Five Years in Canada Supporting And Committed To People Living With ALS

~ Company’s legacy includes first new treatment option for patients with ALS in Canada in almost 20 years ~

TORONTO, ON, November 29, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA) is proud to commemorate the company’s fifth year operating in Canada. Since its inception in 2018, MTP-CA has been at the forefront of advancing scientific innovation and improving access to treatment for Canadians with serious and life-threatening diseases, including Amyotrophic Lateral Sclerosis (ALS), a rapidly progressive, neurodegenerative disease.¹ A key milestone in the company’s legacy in Canada was the 2018 Health Canada approval of the first new treatment option for patients with ALS in nearly 20 years.² In 2022, following a Priority Review by Health Canada, MTP-CA introduced an oral suspension version of its drug that is formulated with the challenges of people living with ALS in mind.

“Over the past five years, our unwavering patient-first philosophy and commitment to tackling the toughest challenges in medicine has led to the successful introduction of two new treatment options for Canadians living with ALS,” said Andy Zylak, President, MTP-CA. “Reaching this important milestone is a testament to the dedication and hard work of our exceptional team, and the support of the ALS community, who are at the centre of everything we do.”

MTP-CA is the Canadian affiliate of Japan-based company Mitsubishi Tanabe Pharma Corporation (MTPC), one of the world’s oldest pharmaceutical companies, leading the discovery and development of innovative therapies. Since being established in Canada, MTP-CA has fostered strong relationships within the ALS community through significant investments and partnerships, including advocacy, education, awareness, research and innovation.

“MTP-CA has a strong history of supporting the ALS community through participation in local fundraising events and sponsoring important initiatives, including the ALS Research Forum and Fellowship programs,” said Tammy Moore, CEO, ALS Society of Canada. “We are grateful for their partnership and their work in advancing the discussion on timely and equitable access to therapies on behalf of people living with ALS and their work to help shorten the time to diagnosis.”

During the past five years, MTP-CA has also invested heavily in research and development projects, including forward-thinking health solutions so that patients may access therapies earlier on in their disease, collaborations with partners in the ecosystem to generate real-world evidence (RWE) and one-of-a-kind solutions to help advance the clinical practices of healthcare professionals (HCPs). Some of the company’s recent accomplishments include:

• How to Break the News in ALS/MND: A Primer for Physicians and Allied Health Professionals – supported by MTP-CA and developed by an expert steering committee, led by Angela Genge, MD, Executive Director, ALS Centre of Excellence at The Neuro in Montreal, this program aims to help HCPs better understand the impact that delivering news of an ALS or motor neuron disease (MND) diagnosis can have on patients, caregivers, and on HCPs themselves.³
• Process for Progress in ALS: An EMR-based practice enhancement initiative – an important new artificial intelligence (AI) program designed to analyze de-identified electronic medical records (EMRs) and identify individuals for which follow-up investigations for ALS or referral to a specialty centre may be clinically appropriate. The cutting-edge technology*, developed by Ensho Health, aims to improve early detection of ALS and support HCPs in making timely decisions. The program is a collaboration between MTP-CA and the program’s Steering Committee: Dr. Angela Genge, Executive Director, Clinical Research Unit at The Neuro in Montreal, Dr. Amer A. Ghavanini, Division Head of Neurology, Trillium Health Partners, and Dr. Amanda Fiander, Neurologist at Maritime Neurology.⁴
• Real-World Evidence Study: MTP-CA is collaborating with the Canadian Neuromuscular Disease Registry (CNDR), an independent, academic registry based out of the University of
  Calgary, on the first Canadian RWE generation study of MTP-CA’s ALS drug. The study aims to collect valuable real-world data on the role of the drug in the treatment of ALS and uncover insights that will ultimately benefit people living with ALS and their families.⁵

“We are proud of our accomplishments over the past five-years, and we remain committed to fighting for the ALS community in Canada by continuing to pursue scientific innovation and improving access to treatments,” added Zylak. “As we look towards the future, we will continue to build on our legacy by seeking new solutions for other difficult to treat neurological diseases and conditions such as Parkinson’s disease and spinal cord injury.”

*The MNd-5 algorithm is a process for converting input parameters to a likelihood estimate. It is deployed at the Toronto, Canada data lab of Ensho Health through the MNd-5 CDL Module (“CDL Module”). The CDL Module is comprised of the MNd-5 Likelihood Estimator (“Likelihood Estimator”) which encodes it in software and a graphical user interface called the MNd-5 Controller (“Controller”). The CDL Module was developed to the ISO 13485:2016 standard for medical devices in compliance with Ensho’s Quality Management System. The MNd-5 CDL Module is registered as medical device software in Canada under the Medical Device Establishment License of Ensho Health (license 16208). The software that encodes the MNd-5 algorithm and applies it to EHR data is Class I medical device software in Canada developed and deployed under the Medical Device Establishment License of Ensho Health.

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About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² Health Canada Drug Database. Available at: https://health-products.canada.ca/dpd-bdpp/. Accessed on September 28, 2023.
³ International Alliance of ALS and MND Associations. How to Break the News in ALS/MND. Available at: https://www.als-mnd.org/support-for-health-professionals/how-to-break-the-news-in-als-mnd/. Accessed on September 19, 2023.
⁴ Process for Progress in ALS: An EMR-based practice enhancement initiative. Available at: https://www.alsprogress.ca/. Accessed on September 19, 2023.
⁵ Abrahao, Agressandro; Vyas, Manav V; Parks, Andrea; Hodgkinson, Victoria; et al. Abstract: Real-World Survival Effectiveness of Edaravone in Amyotrophic Lateral Sclerosis: A Propensity Score Weighted, Registry-Based, Canada-Wide Cohort Study. Presented at the Canadian Neurological Sciences Federation’s Congress 2023.

Mitsubishi Tanabe Pharma Canada Announces That Company’s Oral Treatment Formulation For Amyotrophic Lateral Sclerosis (ALS) Has Been Added To The Provincial Drug Plans In Prince Edward Island, Newfoundland And Labrador

TORONTO, ON, November 7, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under the Prince Edward Island (PEI) Pharmacare Formulary (special authorization) and the Newfoundland and Labrador Prescription Drug Program (NLPDP) (special authorization) for the treatment of people living with amyotrophic lateral sclerosis (ALS), a rapidly progressive, neurodegenerative disease.¹

“We would like to thank the Governments of Prince Edward Island and Newfoundland and Labrador for supporting eligible patients living with ALS to have publicly funded access to RADICAVA® Oral Suspension,” said Andy Zylak, President, MTP-CA. “To date, RADICAVA® Oral Suspension is listed on the majority of provincial public drug plans. MTP-CA will continue to work with the remaining provincial, territorial and federal drug plans to help ensure that RADICAVA® Oral Suspension is listed on all public formularies across the country.”

The efficacy of RADICAVA® Oral Suspension, is based on a bioavailability/bioequivalence study comparing it to RADICAVA® IV, which was authorized by Health Canada for the treatment of people with ALS in October 2018 and has shown in a pivotal trial to slow the loss of physical function in ALS by 33%.²,³ RADICAVA®  IV Infusion is currently available and reimbursed through public formularies in all provinces and territories across Canada, as well as Veterans Affairs Canada and Indigenous Services Canada.

“Today’s news is good news for the ALS community in Newfoundland and Labrador”, said Dr. Alan Goodridge, Neurologist with NL Health Services based in St. John’s and Professor of Medicine (Neurology) at Memorial University. “Given the rapid progression of ALS, it is important that patients have access to all approved therapies to treat this disease.”

According to the ALS Society of Canada, an estimated 3,000 Canadians are currently living with ALS⁴, an incurable disease that affects the nerve cells in the brain and spinal cord.⁵ The majority of people with ALS die within two to five years of diagnosis.⁶ Symptoms of the condition can be subtle at first, and it can take an average of 21 months to receive a diagnosis of ALS in Canada.⁷,⁸

“We commend the Government of Prince Edward Island for making RADICAVA® Oral Suspension available on the province’s drug plan,” said Kathy MacNeill, Past-President, ALS Society of Prince Edward Island. “Access to new treatments plays a key role in helping people and their families live their best possible life in the face of an ALS diagnosis.”

“People living with ALS do not have the luxury of time to wait for access to new medications to slow the progression of their disease,” said Cheryl Power, Executive Director of the ALS Society of Newfoundland and Labrador. “For this reason, we’re pleased that people impacted by ALS in this province will now have publicly funded access to RADICAVA® Oral Suspension.”

In addition to Prince Edward Island and Newfoundland and Labrador, RADICAVA® Oral Suspension, is listed on the public drug plans in Ontario, Alberta, Quebec, British Columbia, New Brunswick, Nova Scotia and Saskatchewan. To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension. MTP-CA continues to have discussions with the territories and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.

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About RADICAVA® IV and RADICAVA® Oral Suspension (edaravone)

RADICAVA® IV and RADICAVA® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA® was approved by the U.S. Food and Drug Administration (FDA) in May of 2017. Marketing authorization for RADICAVA® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² RADICAVA® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
³ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505-512.
⁴ Benchmarking Survey, Federation of ALS Societies of Canada, 2016.
⁵ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
⁶ Mehta P, Kaye W, Raymond J, Punjani R, Larson T, Cohen J, et al. Prevalence of Amyotrophic Lateral Sclerosis – United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67:1285-1289.
⁷ Richards D, Morren JA, Pioro EP. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
⁸ Hodgkinson VL, Lounsberry J, Mirian A, Genge A, Benstead T, Briemberg H, et al. Provincial Differences in the Diagnosis and Care of Amyotrophic Lateral Sclerosis. Can J Neurol Sci. 2018;45:652-659

Canadian-Developed AI Technology Aims To Support Early Detection Of ALS

~ MNd-5 algorithm screens electronic medical records to assist physicians in identifying individuals for
which follow-up investigations for ALS may be appropriate ~

TORONTO, ON, September 20, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA) is proud to support the development of a new artificial intelligence (AI) program designed to analyze de-identified electronic medical records (EMRs) and identify individuals for which follow-up investigations for Amyotrophic Lateral Sclerosis (ALS), or referral to a specialty centre may be clinically appropriate. Process for Progress in ALS: An EMR-based practice enhancement initiative utilizes a clinical algorithm, MNd-5, and is intended to support healthcare professionals (HCPs) in making timely decisions regarding follow-up testing or referral to a specialist.

“Early diagnosis and treatment of ALS can improve outcomes, but the disease can be difficult to diagnose in its early stages. The more time that passes before diagnosis, the less opportunities exist for disease-management for someone living with ALS,” said Dr. Angela Genge, Executive Director, ALS Centre of Excellence at The Neuro in Montreal. “Process for Progress in ALS is a unique advancement in AI medical technology which can help HCPs identify patients who present multiple warning signs for ALS so that they can receive expedited follow-ups, diagnoses, and treatment if needed.”

ALS, also known as Lou Gehrig’s disease, is a neurodegenerative disease that currently has no cure and can progress rapidly.¹ The disease is challenging to diagnose because symptoms of the condition can be subtle at first and no test can provide a definitive diagnosis. In Canada, it takes an average of 21 months to receive a diagnosis of ALS.²,³ The majority of people with ALS die within three years from symptom onset.²

“As a participant in the Process for Progress in ALS initiative, I believe it is a significant step forward to assist in our ability to identify ALS symptoms in the early stages and confidently refer people for further testing or to an ALS centre,” said Dr. Hamza Jalal, neurologist at Oakville Valley Health, who is participating in the program. “By intervening in patients’ journeys earlier in the course of their disease, we can provide access to multidisciplinary care, approved therapies or clinical trials that can slow the progression of the disease and enhance the quality of their lives.”

The MNd-5 algorithm* is intended for use as a clinical decision support tool to aid community neurologists in identifying individuals in which follow-up investigations for ALS or referral to a specialty centre may be clinically appropriate. It prioritizes patients for clinical review by comparing their presenting characteristics and EMG findings to a reference population of patients diagnosed with ALS, in which ALS has been ruled out and consecutive community neurology patients in which ALS and other motor neuron diseases have not previously been suspected. The algorithm is applied to electronic health records at the Toronto Data Lab of Ensho Health as a service. The service is available to approximately 80% of community
neurologists through integrations with the Epic, Cerner, Accuro, OscarPro, Indivicare, Mediquest and other electronic medical record systems.

“We know that time is of the essence for people living with ALS, and initiatives like Process for Progress in ALS are critical in helping to ensure a timely diagnosis for people impacted by this devastating disease,” said Andy Zylak, President, Mitsubishi Tanabe Pharma Canada. “We are proud to support the introduction of this important AI technology as part of our long-standing commitment to leading scientific innovation, collaborating with HCPs, and working tirelessly to meet the needs of the ALS community.”

The Process for Progress in ALS initiative is a collaboration between MTP-CA and the program’s Steering Committee: Dr. Angela Genge, Executive Director, Clinical Research Unit at The Neuro in Montreal, Dr. Amer A. Ghavanini, Division Head of Neurology, Trillium Health Partners, and Dr. Amanda Fiander, Neurologist at Maritime Neurology.

For more information on Process for Progress in ALS: An EMR-based practice enhancement initiative, please visit: https://www.alsprogress.ca.

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About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

*The MNd-5 algorithm is a process for converting input parameters to a likelihood estimate. It is deployed at the Toronto, Canada data lab of Ensho Health through the MNd-5 CDL Module (“CDL Module”). The CDL Module is comprised of the MNd-5 Likelihood Estimator (“Likelihood Estimator”) which encodes it in software and a graphical user interface called the MNd-5 Controller (“Controller”). The CDL Module was developed to the ISO 13485:2016 standard for medical devices in compliance with Ensho’s Quality Management System. The MNd-5 CDL Module is registered as medical device software in Canada under the Medical Device Establishment License of Ensho Health (license 16208). The software that encodes the MNd-5 algorithm and applies it to EHR data is Class I medical device software in Canada developed and deployed under the Medical Device Establishment License of Ensho Health.

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health, June 2013, https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet
² Richards D, et al. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
³ Hodgkinson VL, et al. Provincial differences in the diagnosis and care of amyotrophic lateral sclerosis. Can J Neurol Sci. 2018;45:652-659

Mitsubishi Tanabe Pharma Canada Announces That Company’s Oral Treatment Formulation For Amyotrophic Lateral Sclerosis (ALS) Has Been Added To The Provincial Drug Plans In Saskatchewan

TORONTO, ON, September 1, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under the Saskatchewan Drug Plan Formulary (Exception Drug Status) for the treatment of people living with amyotrophic lateral sclerosis (ALS), a rapidly progressive, neurodegenerative disease.¹

“We’d like to thank the Government of Saskatchewan for making RADICAVA® Oral Suspension available to those who are eligible for coverage under the province’s public formulary,” said Andy Zylak, President, MTP-CA. “Today’s announcement is excellent news for the ALS community in this province and MTP-CA will continue to work with the remaining provincial, territorial and federal drug plans to help ensure that RADICAVA® Oral Suspension is listed on all public formularies across the country.”

The efficacy of RADICAVA® Oral Suspension, is based on a bioavailability/bioequivalence study comparing it to RADICAVA® IV, which was authorized by Health Canada for the treatment of people with ALS in October 2018 and has shown in a pivotal trial to slow the loss of physical function in ALS by 33%. ²,³ RADICAVA® IV Infusion is currently available and reimbursed through public formularies in all provinces and territories across Canada, as well as Veterans Affairs Canada and Indigenous Services Canada.

According to the ALS Society of Canada, an estimated 3,000 Canadians are currently living with ALS⁴, an incurable disease that affects the nerve cells in the brain and spinal cord.⁵ The majority of people with ALS die within two to five years of diagnosis.⁶ Symptoms of the condition can be subtle at first, and it can take an average of 21 months to receive a diagnosis of ALS in Canada.⁷,⁸

“Due to the swift progression of this disease, it is imperative that people living with ALS have publicly funded access to all approved therapies that could help slow the loss of physical function,” said Denis Simard, Executive Director, ALS Society of Saskatchewan. “That’s why today’s news is an important milestone for people living with ALS in the province, their families and loved ones.”

In addition to Saskatchewan, RADICAVA® Oral Suspension, is also listed on the public drug plans in Ontario, Alberta, Quebec, British Columbia, New Brunswick, and Nova Scotia. To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension. MTP-CA continues to have discussions with other provinces, territories and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.

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About RADICAVA® IV and RADICAVA® Oral Suspension (edaravone)
RADICAVA® IV and RADICAVA® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA® was approved by the U.S. Food and Drug Administration (FDA) in May of 2017. Marketing authorization for RADICAVA® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² RADICAVA® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
³ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505-512.
⁴ Benchmarking Survey, Federation of ALS Societies of Canada, 2016.
⁵ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
⁶ Mehta P, Kaye W, Raymond J, Punjani R, Larson T, Cohen J, et al. Prevalence of Amyotrophic Lateral Sclerosis – United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67:1285-1289.
⁷ Richards D, Morren JA, Pioro EP. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
⁸ Hodgkinson VL, Lounsberry J, Mirian A, Genge A, Benstead T, Briemberg H, et al. Provincial Differences in the Diagnosis and Care of Amyotrophic Lateral Sclerosis. Can J Neurol Sci. 2018;45:652-659

Mitsubishi Tanabe Pharma Canada Announces That Company’s Oral Treatment Formulation For Amyotrophic Lateral Sclerosis (ALS) Has Been Added To The Provincial Drug Plans In New Brunswick And Nova Scotia

TORONTO, ON, August 29, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under the New Brunswick Drug Plan (NBDP) formulary (special authorization) and the Nova Scotia Formulary (exceptional status) for the treatment of people living with amyotrophic lateral sclerosis (ALS), a rapidly progressive, neurodegenerative disease.¹

“We would like to thank the Governments of New Brunswick and Nova Scotia for supporting eligible patients living with ALS in the Atlantic provinces to have publicly-funded access to RADICAVA® Oral Suspension,” said Andy Zylak, President, MTP-CA. “We will continue to collaborate with decision makers to help ensure that RADICAVA® Oral Suspension is made available through all publicly funded drug plans.”

The efficacy of RADICAVA® Oral Suspension, is based on a bioavailability/bioequivalence study comparing it to RADICAVA® IV, which was authorized by Health Canada for the treatment of people with ALS in October 2018 and has shown in a pivotal trial to slow the loss of physical function in ALS by 33%.²,³ RADICAVA®  IV Infusion is currently available and reimbursed through public formularies in all provinces and territories across Canada, as well as Veterans Affairs Canada and Indigenous Services Canada.

“Today’s announcement is an important step forward for people living with ALS in New Brunswick because it gives greater access to a new and less burdensome treatment shown to slow the decline of physical function in ALS,” said Dr. Colleen O’Connell, Physical Medicine and Rehabilitation specialist and Professor at Dalhousie University. “As an ALS clinic physician this is good news. We need our patients to have access to approved therapies that have demonstrated benefit in treating this devastating disease.”

“Over time, ALS weakens the muscles, which impacts physical function of the body and the activities of daily living for people living with this progressive neurodegenerative disease,” said Dr. Amanda Fiander, neurologist, Maritime Neurology in Halifax. “Given the rapid progression of this disease, it is important that patients have access to all approved therapies that can help slow the progression.”

According to the ALS Society of Canada, an estimated 3,000 Canadians are currently living with ALS⁴, an incurable disease that affects the nerve cells in the brain and spinal cord.⁵ The majority of people with ALS die within two to five years of diagnosis.⁶ Symptoms of the condition can be subtle at first, and it can take an average of 21 months to receive a diagnosis of ALS in Canada.⁷,⁸

“We commend the Governments of New Brunswick and Nova Scotia for prioritizing the needs of people living with ALS in Atlantic Canada,” said Kimberly Carter, President and CEO, ALS Society of New Brunswick and Nova Scotia. “Access to new treatments plays a key role in helping people and their families live their best possible life in the face of an ALS diagnosis. We urge the remaining provinces to provide the same commitment by ensuring access to all approved therapies for ALS patients, no matter where they live.”

In addition to New Brunswick and Nova Scotia, RADICAVA® Oral Suspension is also listed on the public drug plans in Ontario, Alberta, Québec and British Columbia. To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension. MTP-CA continues to have discussions with other provinces, territories and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.

-30-

About RADICAVA® IV and RADICAVA® Oral Suspension (edaravone)
RADICAVA® IV and RADICAVA® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA® was approved by the U.S. Food and Drug Administration (FDA) in May of 2017. Marketing authorization for RADICAVA® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² RADICAVA® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
³ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505-512.
⁴ Benchmarking Survey, Federation of ALS Societies of Canada, 2016.
⁵ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
⁶ Mehta P, Kaye W, Raymond J, Punjani R, Larson T, Cohen J, et al. Prevalence of Amyotrophic Lateral Sclerosis – United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67:1285-1289.
⁷ Richards D, Morren JA, Pioro EP. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
⁸ Hodgkinson VL, Lounsberry J, Mirian A, Genge A, Benstead T, Briemberg H, et al. Provincial Differences in the Diagnosis and Care of Amyotrophic Lateral Sclerosis. Can J Neurol Sci. 2018;45:652-659

Mitsubishi Tanabe Pharma Canada Announces That Company’s Oral Treatment Formulation For Amyotrophic Lateral Sclerosis (ALS) Has Been Added To The Provincial Drug Plan In British Columbia

TORONTO, ON, August 18, 2023 – Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under British Columbia PharmaCare (special authority) for the treatment of people living with amyotrophic lateral sclerosis (ALS), a rapidly progressive, neurodegenerative disease.¹

“We are extremely grateful to the Government of British Columbia for their decision to make RADICAVA® Oral Suspension available to those who are eligible for coverage under BC PharmaCare,” said Andy Zylak, President, MTP-CA. ”This is excellent news for the province’s ALS community and we will continue to collaborate with decision makers to help ensure that RADICAVA® Oral Suspension is made available through all publicly funded drug plans.”

The efficacy of RADICAVA® Oral Suspension, is based on a bioavailability/bioequivalence study comparing it to RADICAVA® IV, which was authorized by Health Canada for the treatment of people with ALS in October 2018 and has shown in a pivotal trial to slow the loss of physical function in ALS by 33%.²,³ RADICAVA®  IV Infusion is currently available and reimbursed through public formularies in all provinces and territories across Canada, as well as Veterans Affairs Canada, Indigenous Services Canada and Correctional Service Canada.

According to the ALS Society of Canada, an estimated 3,000 Canadians are currently living with ALS⁴, an incurable disease that affects the nerve cells in the brain and spinal cord.⁵ The majority of people with ALS die within two to five years of diagnosis.⁶ Symptoms of the condition can be subtle at first, and it can take an average of 21 months to receive a diagnosis of ALS in Canada.⁷,⁸

“With a progressive disease like ALS, equitable and timely access to all approved treatment options that could benefit people living with ALS is crucial” said Wendy Toyer, Executive Director, ALS Society of British Columbia. “We applaud the Government of British Columbia’s decision to reimburse RADICAVA® Oral Suspension and we urge other provinces to move quickly and give people living with ALS across the country the same opportunity.”

In addition to British Colombia, RADICAVA® Oral Suspension is also listed on the public drug plans in Ontario, Alberta and Québec. To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension. MTP-CA continues to have discussions with other provinces, territories, and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.

-30-

About RADICAVA® IV and RADICAVA® Oral Suspension (edaravone)
RADICAVA® IV and RADICAVA® Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) through an iterative clinical development platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. RADICAVA® was approved by the U.S. Food and Drug Administration (FDA) in May of 2017. Marketing authorization for RADICAVA® IV Infusion was granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), and Malaysia (December 2021).

RADICAVA® ORS (edaravone) was approved by the U.S. FDA in May 2022. RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) with a goal to provide therapies for some of the most difficult-to-treat diseases, including ALS. For more information, please visit mtpa-ca.staging.ascenderstudios.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

Media Inquiries:
Media_MTPA@mt-pharma-us.com

References:

¹ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
² RADICAVA® Product Monograph. Mitsubishi Tanabe Pharma America, Inc.; 2022.
³ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16:505-512.
⁴ Benchmarking Survey, Federation of ALS Societies of Canada, 2016.
⁵ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health. Available at: https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/amyotrophic-lateral-sclerosis-als-fact-sheet. Accessed on June 6, 2023.
⁶ Mehta P, Kaye W, Raymond J, Punjani R, Larson T, Cohen J, et al. Prevalence of Amyotrophic Lateral Sclerosis – United States, 2015. MMWR Morb Mortal Wkly Rep. 2018;67:1285-1289.
⁷ Richards D, Morren JA, Pioro EP. Time to diagnosis and factors affecting diagnostic delay in amyotrophic lateral sclerosis. J Neurol Sci. 2020;417:117054.
⁸ Hodgkinson VL, Lounsberry J, Mirian A, Genge A, Benstead T, Briemberg H, et al. Provincial Differences in the Diagnosis and Care of Amyotrophic Lateral Sclerosis. Can J Neurol Sci. 2018;45:652-659