Press Release

Mitsubishi Tanabe Pharma America Showcases Breadth of ALS Research at Virtual 32nd International Symposium on ALS/MND

Presentations Include 24-week Results from Global Phase 3 Study of
Investigational Oral Edaravone

JERSEY CITY, N.J., December 1, 2021 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced seven presentations on amyotrophic lateral sclerosis (ALS) as part of the Motor Neurone Disease Association (MNDA) 32nd International Symposium on ALS/MND, being held virtually December 7-10.

“We look forward to sharing our ongoing research with the ALS community, including the 24-week results from our global Phase 3 study of investigational oral edaravone in the treatment of ALS, as well as details from the ongoing REFINE-ALS biomarker study,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “We are committed to the fight against ALS and continuing to pursue a better understanding of the impact of treatment options on this devastating disease.”

ALS data to be presented at the meeting include:

Oral Edaravone Development Program
Presentations include the 24-week results from the global Phase 3 multi-center, open-label study (MT-1186-A01) of investigational oral edaravone in patients with ALS, and the design of an open-label extension study (MT-1186-A03) that is continuing the investigation of safety and tolerability of oral edaravone. Both A01 and A03 studies are conducted by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA). Additionally, an overview of four Phase 1 open-label clinical pharmacology studies for oral edaravone in healthy subjects and patients with ALS will be presented.

  • Bioequivalence Study Between an Investigational Oral Formulation and the IV Formulation of Edaravone in Healthy Subjects (Stephen Apple, M.D.; MTPA)
    Poster Session A, 11:50 a.m. – 1:20 p.m. EST, December 7
  • 24-Week Results From the MT-1186-A01 Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (Angela Genge, M.D., FRCP; Montreal Neurological Institute and Hospital)
    Poster Session C, 11:50 a.m. – 1:20 p.m. EST, December 9
  • Study Design for a Phase 3 Multicenter, Open-Label, Safety Extension Study of Investigational Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Daniel Selness, R.N., B.A., MBA; MTDA)
    Poster Session C, 11:50 a.m. – 1:20 p.m. EST, December 9
  • A Randomized, Open-Label, Crossover-Design, Single-Dose Phase 1 Study to Investigate the Safety, Tolerability, and Comparative Bioavailability of Investigational Oral Edaravone Administered Orally and via a Nasogastric Tube (NGT) in Health Adult Subjects (MT-1186-Z-101) (Antoinette Harrison, PharmD, BCPP, BCGP, FASCP1; MTPA)
    Poster Session C, 11:50 a.m. – 1:20 p.m. EST, December 9

REFINE-ALS Biomarker Study
Details from the ongoing REFINE-ALS Phase 4 study will be presented. The study combines standardized sample collection procedures with optimized biomarker assays to obtain real-world data on a variety of biomarkers in a broad group of patients with ALS. Presentations include an overview of COVID-19 related protocol amendments that were intended to address the safety of people with ALS during the pandemic and minimize potential impact on clinical trial management.

  • COVID-19 Mitigation Strategies Utilized in the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (James Berry, M.D.; Massachusetts General Hospital)
    Poster Session A, 11:50 a.m. – 1:20 p.m. EST, December 7
  • Biomarker Assays Utilized in the Radicava/Edaravone Findings in Biomarkers from the ALS (REFINE-ALS) Study (James Berry, M.D.; Massachusetts General Hospital)
    Poster Session C, 11:50 a.m. – 1:20 p.m. EST, December 9

Ongoing Post-Marketing Surveillance Study in Japan
Results from the ongoing SUNRISE Japan post-marketing surveillance study will be provided by Mitsubishi Tanabe Pharma Corporation (MTPC). The study aims to obtain real-world data about the long-term outcomes in people with ALS in Japan for up to five years.

  • Information of Patients from Ongoing Post-Marketing Surveillance, Evaluating the Real-World Safety and Effectiveness of Edaravone for Amyotrophic Lateral Sclerosis Patients in Japan (SUNRISE Japan) (Kenta Yoshimura, MTPC)
    Poster Session B, 7:15 a.m. – 8:45 a.m. EST, December 8

To learn more about MTPA’s treatments and resources for patients living with ALS, explore the company’s virtual booth at MTPAProfessionalConnection.com.

About Oral Edaravone (MT-1186)
MT-1186 is an investigational oral formulation of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers together with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Osaka, Japan. More information on the oral edaravone development program is available at ClinicalTrials.gov (NCT04165824 and NCT04577404).

About RADICAVA® (edaravone) IV
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) IV on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone IV was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), and Thailand (April 2021).

INDICATION
RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:

  • have asthma.
  • are allergic to other medicines.
  • are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA?

  • RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
  • Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
  • RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
  • Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
  • Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.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’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to 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.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under the mission of “Creating hope for all facing illness,” and has set the corporate vision for 2030 (VISION 30) to “Be a healthcare company that delivers optimal therapy to each individual.” As part of the vision for 2030, MTPC is prioritizing work on “precision medicine” to create effective therapies and preventive methods by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is 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. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/.

About Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTDA is dedicated to research and develop innovative pharmaceutical products that address the unmet medical needs of patients. For more information, please visit https://mt-pharma-development-america.com/.

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

  1. RADICAVA® (edaravone) U.S. Prescribing Information. March 2021.