Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses

JERSEY CITY, N.J., July 5, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9^th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6^th World Parkinson Congress (WPC), being held in Barcelona, July 4-7.

"Our presence at EAN and WPC this year underscores MTPA's dedication to investigating potential treatment options to tackle the current unmet needs and challenges of Parkinson's disease," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations."

Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company. If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S.

Presentations at EAN
Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD).

• Summary of results from a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612
  (Nelson Lopes, M.D.; NeuroDerm)
  ePoster #EPO-610
  
  
• Continuous subcutaneous levodopa/carbidopa infusion for PD: Summary of results from the 3-Year data from the BeyoND study
  (Nelson Lopes, M.D.; NeuroDerm)
  ePresentation #EPR-282
  
  
• Relative bioavailability of levodopa administered as a subcutaneous infusion with ND0612 versus oral IR levodopa/carbidopa
  (Sophia Sopromadze, M.D.; NeuroDerm)
  ePresentation #EPR-066

Presentations at WPC
New data from a post-hoc analysis from the 28-day open-label Study 006 will be presented, evaluating the early efficacy of investigational ND0612 in reducing motor fluctuations in study participants treated with a 24-hour ND0612 infusion regimen, along with findings from four case studies describing the long-term (up to five years) experience of participants in the Phase 2b BeyoND study receiving ND0612 treatment. Additional presentations will highlight the development of a Motor Fluctuations Patient Journey Map (MFPJM) for people with PD to describe the holistic patient experience from pre-diagnosis through hospice care with a focus on motor fluctuations, and details on enrollment characteristics of randomized study participants in the Phase 3 BouNDless study. All posters will be on display in the Exhibit Hall during Poster Session 1 from 11:30 a.m. – 1:30 p.m. CEST on July 5.

• Onset of efficacy with continuous, subcutaneous levodopa/carbidopa infusion in patients with PD experiencing motor fluctuations
  (Ryan Case, Ph.D.; NeuroDerm)
  Poster #P38.03
  
  
• Descriptive case studies of patients in their fifth consecutive year of treatment with ND0612
  (Alberto J. Espay, M.D., FAAN; University of Cincinnati, U.S.)
  Poster #P38.04
  
  
• Development of a patient journey map for people living with Parkinson's disease
  (Alberto Albanese; IRCCS Humanitas Research Hospital, Milan)
  Poster #P43.07
  
  
• A Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (NCT04006210)
  (Alberto J. Espay, M.D., FAAN; University of Cincinnati, U.S.)
  Poster #P38.06

This press release is intended for U.S. audiences only.

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 (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 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. 

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SOURCE Mitsubishi Tanabe Pharma America, Inc.