March 19, 2024

Announcement of Publication in The Lancet Neurology from the Clinical Studyof Investigational ND0612 for Parkinson's Disease
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative
Director: Akihiro Tsujimura; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Group,announced that results from the phase 3 clinical study of investigational ND0612 in people
with Parkinson's disease (PD) experiencing motor fluctuations were published in The Lancet
Neurology on March 15 (U.K. time). The clinical study has been conducted by MTPC’s whollyowned subsidiary, NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO: Kengo Isshiki).
Title: Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612)
for Parkinson’s disease with motor fluctuations (BouNDless):a phase 3, randomized, doubleblind, double-dummy, multicentre trial
DOI: https://doi.org/10.1016/S1474-4422(24)00052-8
The data published in The Lancet Neurology includes the results of a phase 3 trial evaluating
the efficacy, safety and tolerability in a group of patients receiving investigational ND0612 - acontinuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) in comparison to a group of patients receiving oral immediate-release LD/CD in people withPD experiencing motor fluctuations. Key study findings include:Treatment with ND0612 demonstrated favorable efficacy with a statistically significantaddition (p<0.0001) of 1.72 hours in “ON” time without troublesome dyskinesia over oral
IR-LD/CD, thus meeting the trial’s primary endpoint.

The trial also demonstrated positive and clinically meaningful results for the first foursecondary endpoints, including the key secondary endpoint with an additional 1.40-hour
reduction in daily “OFF” time (p<0.0001) with ND0612 vs. oral IR-LD/CD.

The remaining secondary endpoints that reached statistical significance were theMovement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)Part II scores (-3.05 [-4.28, -1.81], p<0.0001), the Patients Global Impression of Change(Odds Ratio [OR]: 5.31 [2.67, 10.58], p<0.0001) and Clinician Global Impression ofImprovement (OR: 7.23 [3.57, 14.64], p<0.0001).

The systemic safety profile of ND0612 was consistent with the well-established safety
profile of oral standard of care LD/CD. Infusion site reactions (ISRs) were the mostreported treatment emergent adverse events (TEAEs) in any group during the DBDD
period (57% for ND0612 vs. 43% for IR-LD/CD).

Some infusion site reactions (infusion site nodule, infusion site bruising, infusion site
infection, infusion site erythema, infusion site pain, infusion site eschar and infusion siteswelling) were more frequent in the ND0612 group compared to placebo and oral LD/CD
groups. Additionally, only 6% of study participants discontinued the trial during the DBDD

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period due to any reason – including 5% due to AEs – compared to discontinuation rates
of 6% and 3%, respectively, of study participants in the oral LD/CD groups.
MTPC Group is focusing on R&D related to the central nervous system disease area and isfurther continuing to create new treatment options for all facing neurodegenerative diseases.
MTPC group believes that the publication of positive clinical results support ND0612 – acontinuous, 24 hours/day SC infusion of liquid LD/CD, as a potential treatment option forpeople with PD experiencing motor fluctuations.
Contact:
Mitsubishi Chemical Group Corporation
Corporate Communications Division
Osaka Corporate Communications Department+81-6-6205-5119◼

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 motorfluctuations 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. If approved,Mitsubishi Tanabe Pharma America, Inc. (MTPA), an MTPC wholly-owned subsidiary (HeadOffice: Jersey City, NJ, USA; President: Yasutoshi Kawakami), intends to commercialize thetherapy in the U.S.
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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 ofpatients and their families through innovative drug-device combination therapies andtechnologies. 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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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 in2015 to develop and advance our pipeline as well as commercialize approved pharmaceuticalproducts in North America. For more information, please visit www.mt-pharma-america.com

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