Posters will highlight findings from studies evaluating investigational ND0612 in Parkinson's disease and RADICAVA ORS (edaravone) in ALS

JERSEY CITY, N.J., Sept. 12, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four presentations will be shared at the American Neurological Association (ANA) 2024 Annual Meeting being held September 14-17 in Orlando, Fla. The presentations will discuss two abstracts in Parkinson's disease (PD) and two in amyotrophic lateral sclerosis (ALS).

"We look forward to sharing the latest findings from our studies in Parkinson's disease and ALS at this year's ANA meeting," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our presentations underscore our unwavering commitment to understanding the high unmet needs within these patient communities through continuous research and innovation."

PD data to be presented at the meeting include:

Investigational ND0612
Presentations include findings from subgroup analyses from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 across a range of sociodemographic groups of people with PD experiencing motor fluctuations, as well as findings from an integrated analysis characterizing infusion site reactions reported in patients treated with ND0612.

• Efficacy of ND0612 a 24-hour Subcutaneous Levodopa/Carbidopa Infusion for People with Parkinson's Disease Experiencing Motor Fluctuations: Subgroup-Analyses from a Randomized, Controlled Phase 3 Study (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA)
  Poster #M2.123: 6:00 p.m. – 7:30 p.m. EST, September 16
• Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612 (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA)
  Poster #M2.124: 6:00 p.m. – 7:30 p.m. EST, September 16

ALS data to be presented at the meeting include:

RADICAVA ORS
Final data from the global, double-blind Phase 3b study MT-1186-A02 will be showcased, including the post-marketing study of an investigational once-daily dosing regimen of RADICAVA ORS (edaravone) to evaluate whether investigational daily dosing displayed superior efficacy vs. the approved on/off dosing regimen of oral edaravone in patients with ALS over 48 weeks. In addition, full results from the RADICAVA ORS Phase 3 open-label safety extension study (MT-1186-A03), which spans 96 weeks, will be presented.

• Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D. Ph.D., MBA, MHA; MTPA)
  Poster #M2.029: 6:00 p.m. – 7:30 p.m. EST, September 16
• Phase 3, 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, MHA; MTPA)
  Poster #M2.046: 6:00 p.m. – 7:30 p.m. EST, September 16

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.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), 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 16,000 people with ALS, with over 1.9-million days of therapy, and have been prescribed by over 2,400 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 .

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

For more information, including full Prescribing Information, please visit .

About ND0612
ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC).

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 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 .

About NeuroDerm, Ltd.
NeuroDerm, Ltd. 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 is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn.

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

SOURCE Mitsubishi Tanabe Pharma America