Mitsubishi Tanabe Pharma America to Showcase ALS Research at 2022 American Academy of Neurology Annual Meeting

Presentations Include Real-World Data on RADICAVA^® (edaravone) and Results from a Global Phase 3 Study of Investigational Oral Edaravone

JERSEY CITY, N.J., April 1, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four presentations on amyotrophic lateral sclerosis (ALS) will be shared as part of the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in Seattle, Wash., from April 2-7 and virtually from April 24-26.

"Our latest research on treatment with edaravone includes analyses of overall survival and treatment outcomes in patients with ALS in a real-world setting, providing additional insight into patient experiences," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These data, as well as presentations on our ongoing global development program for investigational oral edaravone, reinforce our relentless commitment to enhancing our understanding of treatment options for this debilitating disease, and we look forward to sharing them with the scientific community."

ALS data to be presented at the meeting include:

Real-World Data
A real-world analysis of overall survival in patients with ALS treated with intravenous (IV) RADICAVA^® (edaravone) utilizing de-identified data from Optum's Clinformatics^® Data Mart (CDM) database will be presented, as well as an analysis of treatment outcomes in patients treated with RADICAVA IV over 44 months, based on de-identified data collected from providers of home and alternative-site infusions and specialty pharmacy services in the U.S.

• Continued Intravenous Edaravone Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS) Increases Overall Survival Compared With No Intravenous Edaravone Treatment: Results from a US Administrative Claims Database
  (Benjamin R. Brooks, M.D.)
  Poster Session 2 (#P2.13-004): 11:45 a.m. - 12:45 p.m. PST, April 2

• Treatment Outcomes Among Amyotrophic Lateral Sclerosis Patients Receiving Intravenous Edaravone (IV): 44 Months of Follow-up From US Specialty Infusion Centers
  (Malgorzata Ciepielewska, MS; MTPA)
  Poster Session 2 (#P2.13-005): 11:45 a.m. - 12:45 p.m. PST, April 2

Oral Edaravone Development Program
Presentations include 24-week results from the global Phase 3 multi-center, open-label study (MT-1186-A01) of investigational oral edaravone in patients with ALS, as well as the study design from the ongoing Phase 3 open-label extension study (MT-1186-A03) evaluating the long-term safety and tolerability for up to 96 weeks of oral edaravone in patients who completed A01. Both A01 and A03 studies are conducted by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).

• 24-Week Results From Phase 3 Study MT-1186-A01 an 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 1 (#P1.13-001): 8:00 a.m. - 9:00 a.m. PST, April 2

• Study Design for a Phase 3, Multicenter, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)
  (Alejandro Salah, M.D., Ph.D., MBA; MTPA)
  Poster Session 2 (#P1.13-008): 11:45 a.m. - 12:45 p.m. PST, April 2

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) 
Oral edaravone is an investigational oral formulation of edaravone being developed by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc (MTDA). In the last three years, Mitsubishi Tanabe Pharma group companies completed seven Phase 1 clinical pharmacology studies examining the pharmacokinetics, safety, drug-drug interactions, dosing, bioavailability and bioequivalence of the oral suspension in healthy individuals and in patients with ALS with and without a PEG/NGT, and initiated two global, multi-center, open-label, Phase 3 clinical trials evaluating the safety and tolerability of oral edaravone over the course of 24, 48, and 96 weeks in more than 120 patients with ALS across approximately 50 sites in the U.S., Canada, Europe and Japan. More information on the clinical trials 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).¹ 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), Thailand (April 2021), and Malaysia (December 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 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. For more information, please visit https://mt-pharma-development-america.com/.

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/

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

SOURCE Mitsubishi Tanabe Pharma America, Inc.