Press Release

Mitsubishi Tanabe Pharma America Celebrates Five Years of
Dedication to the ALS Community in the U.S.

JERSEY CITY, N.J., February 8, 2021 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today celebrated its five-year anniversary of being established in the United States in 2016. MTPA has followed an unwavering patient-first philosophy focused on advancing innovative treatments for people facing serious and life-threatening diseases, including amyotrophic lateral sclerosis (ALS).

“Having personally been a part of the MTPA journey from the beginning, I am humbled by what we have achieved as one team, with one mission: helping patients,” said Atsushi Fujimoto, President, MTPA. “We have accomplished many things in the first five years working together to serve the ALS community, and we look forward to seeing the journey ahead over the next five years as we continue to expand our product pipeline and strengthen our support of people who  suffer from ALS and other debilitating conditions.”

In 2017, MTPA launched RADICAVA® (edaravone), approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with ALS. Since RADICAVA became available in August 2017, more than 5,500 patients have been treated in the U.S. and approximately 1,500 healthcare providers have prescribed the therapy to one or more of their patients.1

In March 2018, MTPA established a subsidiary, Mitsubishi Tanabe Pharma Canada (MTP-CA), which introduced RADICAVA in Canada in November 2019.

“We deeply appreciate MTPA’s commitment to supporting patients with ALS, their families, and caregivers,” said Donald S. Wood, Ph.D., President and CEO of the Muscular Dystrophy Association. “MDA agrees with MTPA that ‘One scientific breakthrough can change countless lives.’ We look forward to working toward the same goals and hope to achieve many scientific advancements in the years to come.”

Recent MTPA initiatives to support the ALS community include:

  • A licensing and supply deal for the U.S. rights to commercialize EXSERVAN (riluzole), an oral film formulation of riluzole for the treatment of ALS. As a result of the deal, MTPA will be the only company in the U.S. with two FDA-approved ALS treatments.
  • Revised REFINE-ALS biomarker study protocol to address the safety concerns of people with ALS during the COVID-19 pandemic. Changes give patients the ability to consent to participate virtually, with the option to utilize telemedicine and home health agencies in lieu of in-clinic visits. The study is designed to identify and measure specific biomarkers and clinical assessments in people with ALS in the U.S. who are treated with RADICAVA.
  • Enhanced the Searchlight Support® Out-of-Pocket Assistance Program. The updates enable more efficient communication and exchange of information, including a new “hybrid” card that can be used to help access appropriate pharmacy and medical co-pay assistance for eligible patients with commercial insurance.
  • Established the RADICAVA® JourneyMateTM program, which is designed to connect people with ALS and their families to live educational support, which can help answer questions about RADICAVA and ALS.
  • The ALS Care Locator online tool continues to be expanded, and now has more than 1,047 infusion centers listed.
  • Initiated clinical study exploring daily dosing of an investigational oral formulation of edaravone (MT-1186). The study, sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), is the postmarketing commitment following the U.S. FDA approval of RADICAVA IV.

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).2 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. 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 use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.

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 EXSERVAN (riluzole oral film)
EXSERVAN, an oral film formulation of riluzole, was developed by Aquestive Therapeutics using its PharmFilm® innovative drug delivery technology. The oral film is placed on the patient’s tongue and quickly dissolves without the need for liquids or food. RILUTEK® (riluzole) tablets was the reference product during the oral film development. Oral film riluzole was approved by the U.S. Food and Drug Administration (FDA) in November 2019.

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

IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to riluzole or to any of its ingredients.

Before using EXSERVAN, tell your healthcare provider about all the medicines you take and all your health conditions, including if you:

  • Have hepatic (liver) impairment.
  • Are taking strong or moderate CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton.
  • Are pregnant or intend to become pregnant during EXSERVAN therapy, or if you are breastfeeding or intend to breastfeed during EXSERVAN therapy.

EXSERVAN can cause serious side effects, including:

  • Hepatic Injury: Cases of drug-induced liver injury, some fatal, have been reported in patients taking riluzole. Consult your healthcare provider promptly if you experience unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
  • Neutropenia: Tell your healthcare provider if you develop a fever while taking EXSERVAN.
  • Interstitial Lung Disease: Tell your healthcare provider if you have respiratory symptoms such as dry cough and difficult or labored breathing. Discontinue EXSERVAN immediately if interstitial lung disease develops.

The most common side effects include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.

These are not all the possible side effects of EXSERVAN. Consult your healthcare provider for medical advice about side effects and if you have any side effect that bothers you or that does not go away. To report SUSPECTED ADVERSE REACTIONS, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use EXSERVAN as prescribed. The recommended dosage for EXSERVAN is 50 mg taken orally twice daily at least 1 hour before or 2 hours after a meal. Place EXSERVAN oral film strip on the top of the tongue where it will adhere and dissolve. Do not cut or split the film or take liquids with EXSERVAN. Do not chew, spit, or talk while EXSERVAN is dissolving.

For more information, including full Prescribing Information and Patient Information, please click here.

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.

Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.3 In accordance with the corporate philosophy of “contributing to the healthier lives of people around the world through the creation of pharmaceuticals,” the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — immune-inflammation diseases, diabetes and kidney, central nervous system, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and MTDA. For more information, go to https://www.mt-pharma.co.jp/e/.

Media Inquiries:
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com

  1. Mitsubishi Tanabe Pharma America Inc., Data on File as of January 2021. Based on internal data not independently verified.
  2. RADICAVA® U.S. Prescribing Information. August 2018.
  3. Research by TOKYO SHOKO RESEARCH, LTD.