Mitsubishi Tanabe Pharma America Celebrates Eight-Year Anniversary in the U.S.

JERSEY CITY, N.J., April 29, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) is celebrating its eight-year anniversary of being established in the United States (U.S.). In 2016, MTPA was created as a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), with the goal of developing and advancing the company's pipeline in the U.S. while focusing on improving research in the areas of amyotrophic lateral sclerosis (ALS), erythropoietic protoporphyria (EPP), Parkinson's disease, spinal cord injury and systemic sclerosis.

"For almost a decade, MTPA has been dedicated to advancing science and research to support underserved patient populations with complex needs including neurodegenerative diseases, inflammatory, and metabolic conditions," said Yasutoshi Kawakami, President, MTPA. "We're proud to continue the 300-year legacy of our parent company, MTPC in Japan, here in the U.S., where more than 5,000 people each year are diagnosed with ALS.¹ We are excited to pursue promising medical advances as we seek new therapies for people struggling with debilitating diseases."

Over the past eight years, MTPA has achieved success with RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone), the intravenous (IV) and oral formulations of its treatment for ALS.

To date, more than 14,600 people with ALS in the U.S. have received treatment with RADICAVA and/or RADICAVA ORS since the therapies became available in August 2017 and June 2022, respectively. The treatments have been prescribed by over 2,300 healthcare professionals (HCPs) and about 80% of RADICAVA and/or RADICAVA ORS treated patients remain in therapy after three months.^2,3 The FDA recently recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with ALS.

The US approval of edaravone was based on Study 19 (or MCI186-19), a randomized placebo-controlled, pivotal Phase 3 study, which was conducted prospectively in 137 people who met criteria identified from an exploratory analysis of the previously conducted Phase 3 MCI186-16 study. The study was shown to slow the loss of physical function by 33 percent in 68 patients vs placebo (n=66 patients), measured over a 24-week time period by the ALSFRS-R. On average, patients on RADICAVA® IV lost 2.49 fewer points on the ALSFRS-R compared with those in the placebo arm. RADICAVA ORS® offers the same efficacy as RADICAVA® IV in an oral formulation.⁴ Bioequivalence of the IV formulation and oral suspension were proven in a Phase 1 open-label study (MT-1186-J03) in 2021.⁵ The safety profile of the IV formulation of RADICAVA® was evaluated in multiple placebo-controlled studies in 184 patients with ALS. The RADICAVA ORS safety profile was demonstrated in a 6-month clinical study of 185 patients with ALS. The most common side effects were bruising (contusion) [15%], problems with walking (gait disturbance) [13%], and headache [10%]. Fatigue was also reported in 7.6% of patients taking RADICAVA ORS®.⁴

Last November, MTPA was honored to receive the ALS United Greater New York Chapter's Jacob K. Javits Lifetime Achievement Award for groundbreaking work to bring forward a treatment for the ALS community and pave the way for future therapies. MTPA looks to continue this work not only through scientific advancements, but by continuing to support patient advocacy initiatives, including the sponsorship of ALS Walks and community events, along with a sponsorship of Parkinson's Awareness Month in April for the Parkinson's Foundation.

Furthermore, as a part of MTPA's commitment to helping people with ALS access RADICAVA and RADICAVA ORS, MTPA created the JourneyMate Support Program™, which provides educational resources to help patients and caregivers on their ALS treatment journey.

The JourneyMate Support Program™ helps to give patients understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address patient educational needs and provide them with personalized answers and resources for living with ALS. For more information, call 1-866-684-7737 or visit LetsTalkALS.com.

Additionally, MTPA's Share Your Story program empowers people with ALS and their caregivers to express their real-life experiences with this rare disease through videos and written stories. For more information, visit ShareYourALSStory.com.

Nearly one year ago, Mitsubishi Tanabe Pharma Holdings America, Inc. (MTHA) and their development entity, Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), merged into MTPA. "As our company continues to advance our late-stage pipeline, we celebrate this recent integration as it has enabled us to continue to drive discovery and development," said Bijan Nejadnik, Head of Global Development and Regulatory Affairs.

Always looking to the future, MTPA continues to further research in a number of key areas, including Parkinson's disease, EPP and spinal cord injury, among others. For more information, visit www.mtpa.com.

About RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.³

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. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 14,600 people with ALS, with over 1.7-million days of therapy, and have been prescribed by over 2,300 HCPs.^2,3,6

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.

Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

About JourneyMate Support Program™
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed an MTPA product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Mitsubishi Tanabe Pharma America, Inc. (MTPA) product. An ALS Clinical Educator is provided by MTPA and VMS and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient's doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient's doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.

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 (formerly Twitter), Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC 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.mt-pharma.co.jp/e/.

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¹ Mehta P, Kaye W, Bryan L, et al. Prevalence of Amyotrophic Lateral Sclerosis in the United States using established and novel methodologies, 2017 Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):108-116.
² Data on file. Mitsubishi Tanabe Pharma America, Inc.
³ Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁴ RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
⁵ Shimizu H, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197.
⁶ Data on file. Mitsubishi Tanabe Pharma America, Inc.

SOURCE Mitsubishi Tanabe Pharma America