Mitsubishi Tanabe Pharma America to Present Latest Findings Across ALS and Parkinson's Disease at 2023 American Academy of Neurology Annual Meeting

Poster and oral presentations to highlight data from real-world and clinical studies

JERSEY CITY, N.J., April 20, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced six presentations in amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD) will be shared as part of the 2023 American Academy of Neurology (AAN) Annual Meeting, being held virtually and in Boston, Mass., April 22-27.

"We're thrilled to share a broad range of research this year, including new data from a real-world analysis of treatment outcomes with RADICAVA^® (edaravone) in people with ALS, and key findings from our ongoing Phase 2 and Phase 3 studies investigating ND0612 as a potential treatment option for Parkinson's disease, among other presentations," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We strive to push the boundaries of scientific innovation by challenging unmet needs faced by people living with debilitating diseases like ALS and PD, and continue to work diligently to better understand the needs of these patient communities."

ALS data to be presented at the meeting include:

Real-World Data
Presentations include new results from a real-world analysis of treatment outcomes with RADICAVA based on de-identified data collected from a U.S. provider of home and alternative-site infusions, and an analysis of time to progression milestones in people with ALS treated with and without RADICAVA in a real-world setting, utilizing administrative claims data from Optum's Clinformatics^® Data Mart (CDM). The latter will be presented orally as part of a Scientific Platform Session at the meeting.

• Treatment Outcomes for Patients With Amyotrophic Lateral Sclerosis Receiving Intravenous Edaravone From a Home and Alternative-Site Infusion Provider
  (Polina Da Silva; MTPA)
  Poster Session 6 (#4-005): 5:30 p.m. – 6:30 p.m. EDT, April 24
• Longer Milestone Free Time in Patients With Amyotrophic Lateral Sclerosis Treated With IV Edaravone vs Not Treated With IV Edaravone: Results From a US Administrative Claims Analysis
  (Malgorzata Ciepielewska, MS; MTPA)
  Scientific Platform Session S14 (#007): 2:12 p.m. – 2:24 p.m. EDT, April 24

RADICAVA ORS
48-week safety results from the global Phase 3 multi-center, open-label clinical trial (MT-1186-A01) evaluating RADICAVA ORS^® (edaravone) in people with ALS will be shared.

• Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (MT-1186-A01): 48-Week Results
  (Angela L. Genge, M.D.; McGill University)
  Poster Session 6 (#4-001): 5:30 p.m. – 6:35 p.m. EDT, April 24

PD data to be presented at the meeting include:

ND0612 Presentations
Presentations include topline results from the ongoing Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of investigational ND0612 in people with PD experiencing motor fluctuations, in addition to three-year outcomes from the ongoing Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612 in people with PD with motor fluctuations. Findings from the BouNDless and BeyoND studies will be presented orally as part of an Emerging Science Platform Session and Plenary Session, respectively. Additionally, results from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LC/CD) will be shared. All three studies are being conducted by NeuroDerm Ltd., a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company.

• Efficacy and Safety of Continuous Subcutaneous ND0612 Infusion Compared with Oral Immediate-release Levodopa-Carbidopa in Patients with Parkinson's Disease and Motor Fluctuations. Results From the Phase 3 Multicenter, Randomized, Double-blind, Double-dummy BouNDless Trial
  (Alberto J. Espay, M.D., FAAN; University of Cincinnati)
  Emerging Science 1 (#002): 11:21 a.m. – 11:27 a.m. EDT, April 24
• Safety and Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion for Parkinson's Disease: Three-Year Data from the Open-Label BeyoND Study
  (Aaron Ellenbogen, DO; Michigan Institute for Neurological Disorders and Deborah A. Hall, M.D., Ph.D., FAAN; Rush University Medical Center)
  Plenary Session PL4: 10:15 a.m. – 10:35 a.m. EDT, April 24
• Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral immediate-release levodopa/carbidopa tablets
  (Liat Adar; NeuroDerm)
  Poster Session 2 (#11-004): 11:45 a.m. – 12:45 p.m. EDT, April 23

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). RADICAVA is administered in 28-day cycles by 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.¹

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) and Malaysia (December 2021). Marketing authorization for RADICAVA^® Oral Suspension was granted in Canada in November 2022, 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 10,000 people with ALS, with over 1.2-million days of therapy, and have been prescribed by nearly 2,000 HCPs.^2-4

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 ND0612
ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson's disease (PD) experiencing motor fluctuations.

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). 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), the pharma arm of the Mitsubishi Chemical Group, is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. The Mitsubishi Chemical Group 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 prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction 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. For more information, go to https://www.mt-pharma.co.jp/e/.

About NeuroDerm, Ltd. 
NeuroDerm is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm Ltd. is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at www.neuroderm.com or follow the Company on LinkedIn. 

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¹RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
²Data on file. Mitsubishi Tanabe Pharma America, Inc.
³Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁴Data on file. Mitsubishi Tanabe Pharma America, Inc.

SOURCE Mitsubishi Tanabe Pharma America, Inc.