April 4, 2022
Long-Term Safety Profile from Phase 2b Clinical Trials of Parkinson's Disease DrugCandidate (ND0612) Presents at 2022 American Academy of Neurology Annual Meeting
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director:
Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Holdings Group,announced today that the positive long-term safety data from the phase 2b clinical trials (BeyoND
stutdy; hereinafter, “this study”）of the Parkinson's disease drug candidate (ND0612) which is being
conducted by its wholly owned subsidiary, NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO:Ayelet Altman) will be presented at 2022 American Academy of Neurology Annual Meeting(hereinafter, "AAN") on April 5 local time.
Cumulative safety data from 114 participants enrolled in the long-term extension period of this study(beyond one year) with Parkinson’s disease experiencing motor fluctuations will be presented in AAN.
95% of participants who completed one year of treatment enrolled in the extension period (somepatients continuing in their sixth year of treatment) and this is the first time that safety data beyond
one year have been obtained from continuous levodopa/carbidopa treatment. Treatment-emergent
adverse events (TEAEs) were generally mild to moderate. Over more than four years, 17.5% ofparticipants discontinued treatment due to an adverse event after their first year of enrollment,including four (3.5%) patients who withdrew due to infusion site reactions. Infusion site reactions
were the most frequent TEAEs, such as nodules, hematoma, infection, pain, and eschar*1. Nausea
was the drug-related systemic TEAE with incidence over 5% (7.0%).
New treatments are awaited especially by patients with advanced Parkinson’s disease to improvetheir quality of life as most of them experience motor fluctuations and difficult to adequately control
it by oral medications along with the progress of the disease. ND0612, a drug-device combination
product with a subcutaneous delivery system continuous infusion of liquid levodopa/carbidopa, is atherapeutic agent candidate for Parkinson's disease that can potentially offer a more reliable,
sustained relief of motor fluctuations. This study confirms that ND0612 can be the new option thatmeets the unmet medical needs of Parkinson's disease treatment that remains safe and welltolerated over the long-term.
Global phase 3 clinical study of ND0612 is currently ongoing and expected launch in the U.S. andglobally in fiscal 2024. MTPC is focusing on the R&D of central nervous system disease area andfurther continuing to create new options for all facing Parkinson’s disease.
*1 Dry and hard dead tissue
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Mitsubishi Chemical Holdings Group
Corporate Communications Div.
Osaka Corporate Communications Dept.
Media contacts: [+81] (0)6-6205-5119■About Parkinson’s Disease
Parkinson’s disease affects more than five million patients worldwide.1 It is caused by decreasing
dopamine signaling in the brain as dopaminergic brain cells die off.2 Levodopa is the “Gold Standard”
therapy for Parkinson’s disease and nearly all patients receive it, together with a levodopa
degradation

inhibitor(usuallycarbidopa).3 Whenadministeredorally,levodopa

plasmaconcentrations undergo sharp fluctuations reaching high peaks and low troughs that contribute tothe clinical and motor complications in patients with Parkinson’s disease.4 With disease progression,oral levodopa therapy may become less effective while increasing the frequency of motorcomplications, leaving patients with limited treatment options that are highly invasive and/orburdensome.4■About ND0612
ND0612 is the combination product candidate of levodopa and carbidopa combined with acontinuous subcutaneous administration system. ND0612 is a novel approach designed to reduce
motor fluctuations in Parkinson's disease patients by improving the drugs’ pharmacokinetic profileand maintain stable, therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a pharmaceutical company based in Israel with significant capabilities in new
formulation research and technology development for combining pharmaceuticals with medical
devices for the treatment of central nervous system diseases. Mitsubishi Tanabe Pharma wholly
owned NeuroDerm in October 2017 to expand its pipeline in the key R&D disease area, central
nervous system. www.neuroderm.com

References
1.

Global, regional, and national burden of Parkinson’s disease, 1990-2016: a systematic

analysis for the Global Burden of Disease Study 2016. GBD 2016 Parkinson’s Disease Collaborators.
Lancet Neurol 2018; 17: 939-953.
2.

Parkinson’s 101. The Michael J. Fox Foundation. Available at:https://www.michaeljfox.org/parkinsons-101#q2. Accessed March 15, 2022.
3.

S Fahn. Levodopa in the treatment of Parkinson’s disease. J Neural Transm

Suppl.2006;(71):1-15. doi: 10.1007/978-3-211-33328-0_1.
4.

C D Marsden. Problems with long-term levodopa therapy for Parkinson’s disease. Clin

Neuropharmacol. 1994;17 Suppl 2:S32-44.
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