SYNH Syneos Health Inc

• Presentations span Parkinson's disease and ALS clinical and real-world evidence
• Oral platform sessions will highlight results from Phase 3 BouNDless trial in PD and real-world findings from preliminary analysis of RADICAVA^® (edaravone) treatment in ALS

JERSEY CITY, N.J., April 12, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced seven presentations will be shared at the American Academy of Neurology (AAN) 2024 Annual Meeting being held in Denver, Colo., Apr.13-18, 2024. The presentations will discuss four abstracts in Parkinson's disease (PD) and three in amyotrophic lateral sclerosis (ALS).

"We are honored to attend this year's AAN conference, where we will present our latest research in ALS and PD, including new data from Phase 2 and Phase 3 analyses of investigational ND0612 in PD," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "We look forward to sharing key insights and engaging with the scientific community, underscoring our dedication to collaboration and innovation as a part of our larger commitment to further knowledge and understanding of neurodegenerative disorders like PD and ALS."

PD data to be presented at the meeting includes:

Investigational ND0612 
Presentations include new data from a subgroup analysis from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 in different subgroups of people with PD experiencing motor fluctuations, in addition to findings characterizing infusion site reactions (ISR) reported from treatment with ND0612 in clinical studies. Data from the BouNDless subgroup analysis will be presented orally during a Scientific Platform Session at the meeting. Additional presentations include a post-hoc analysis from the 28-day open-label Study 006 evaluating ND0612 efficacy onset data and findings from a responder analysis of the ongoing Phase 2b BeyoND long-term safety study (NCT02726386) assessing efficacy data for ND0612 in reducing OFF time in people with PD with motor fluctuations.

• 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 (Alberto J. Espay, M.D., FAAN; University of Cincinnati)
  Scientific Platform Session S30 (#008): 2:24 p.m. – 2:36 p.m. MDT, April 17
  
  
• Characterization of Infusion Site Reactions (ISR) with 24-hour Subcutaneous Infusion of ND0612: Findings from an Integrated Safety Database (Rajesh Pahwa, M.D., FAAN; University of Kansas Medical Center)
  Poster Session 9 (#3-010): 8:00 a.m. – 9:00 a.m. MDT, April 17
  
  
• Onset of Efficacy with Continuous, Subcutaneous Levodopa/Carbidopa Infusion in Patients with Parkinson's Disease Experiencing Motor Fluctuations (Nelson F. Lopes, M.D.; NeuroDerm)
  Poster Session 9 (#3-012): 8:00 a.m. – 9:00 a.m. MDT, April 17
  
  
• Reductions in OFF Time with ND0612 for People with Parkinson's Disease Experiencing Motor Fluctuations: Responder-Analysis from an Open-Label Study (Stuart H. Isaacson, M.D., FAAN; Parkinson's Disease & Movement Disorders Center of Boca Raton)
  Poster Session 9 (#3-019): 8:00 a.m. – 9:00 a.m. MDT, April 17

ALS data to be presented at the meeting includes:

RADICAVA ORS^® (edaravone)
A preliminary analysis of demographics and clinical characteristics in people with ALS being treated with RADICAVA ORS, utilizing U.S.-based administrative claims data from Optum's Clinformatics^® Data Mart, will be presented orally during a Scientific Platform Session at the meeting.

• A Preliminary Analysis of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.;MTPA)
  Scientific Platform Session S3 (#005): 1:48 p.m. – 2:00 p.m. MDT, April 14

Additional Real-World Data
Additionally, initial results will be presented from a study sponsored by Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) based on data from the Canadian MTP-Patient Support^® program. The study will provide insight into real-world demographics and characteristics of people with ALS treated with RADICAVA. Separately, updates from a prospective study evaluating slow vital capacity in erect-seated and supine positions using in-clinic conventional and in-home, portable spirometry will be presented. 

• Real-World Evidence on Treatment Retention, Safety, and Tolerability of Edaravone in Canadian Patients with Amyotrophic Lateral Sclerosis (Dung Pham, Ph.D.; MTPA-CA)
  Poster Session 5 (#11-012): 5:30 p.m. – 6:30 p.m. MDT, April 15
• Internet-Supervised Home-Based Spirometry through Telemedicine in Amyotrophic Lateral Sclerosis (Eufrosina Young, M.D.; State University of New York Upstate Medical University) 
  Poster Session 6 (#11-013): 8:00 – 9:00 a.m. MDT, April 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). 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 14,600 people with ALS, with over 1.8-million days of therapy, and have been prescribed by more than 2,300 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 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). The safety and efficacy of ND0612 in PD is under review by the U.S. Food and Drug Administration (FDA), who has assigned a Prescription Drug User Fee Act (PDUFA) target action date for the second quarter of CY (calendar year) 2024.

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/. 

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 www.neuroderm.com or follow the Company on LinkedIn. 

Media inquiries:
Media_MTPA@mt-pharma-us.com  

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.

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