August 28th, 2019The Start of a Phase 3 Clinical Trial of Continuous Subcutaneous Liquid
levodopa/carbidopa Administration (ND0612)
for patients with fluctuating Parkinson’s disease
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; President &Representative Director: Masayuki Mitsuka) announced today that its subsidiary,
NeuroDerm Ltd. (Head Office: Rehovot, Israel; Chief Executive Officer and Director:Oded S. Lieberman), has started a pivotal phase 3 clinical trial (BouNDless) ofcontinuous subcutaneous liquid levodopa/carbidopa administration (ND0612) in theU.S.
In the treatment of Parkinson’s disease (PD), as the disease progresses, it isimportant to appropriately control plasma levels of levodopa, a standard of therapyfor PD.
ND0612 is the first liquid formulation of levodopa and carbidopa developed by
NeuroDerm. ND0612 can be continuously and subcutaneously administered, bothday and night, using a small belt pump, thereby providing stable control of theplasma levels of levodopa. This administration is expected to significantly reduce
motor complications, i.e. reduction of impaired motor and non-motor functions andtroublesome dyskinesia, in patients with PD, whose symptoms are no longer
controlled by conventional treatments who have only limited remaining treatment
options that require highly invasive surgery associated with serious side effects.
ND0612 was shown in previous phase 1 and phase 2 studies to be safe, tolerable
and effective.
The BouNDless is aimed to establish efficacy, safety, and tolerability data evidenceof continuous subcutaneous ND0612 infusion in comparison with oral
levodopa/carbidopa in patients with PD experiencing motor fluctuations. Since
levodopa and carbidopa are approved drugs, NeuroDerm plans to submit a505(b)(2) NDA to the FDA, relying, in part, on the FDA’s previous findings from thedata that were not developed by NeuroDerm or published literature.
Many diseases in the world pose issues that cannot be overcome with existingtreatments. Mitsubishi Tanabe Pharma will make continued efforts to deliver
pharmaceuticals to patients fighting against diseases.

Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110

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About Parkinson’s disease
Parkinson’s disease affects approximately 5 million patients worldwide. It is caused
by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.
Levodopa is the “Gold Standard” therapy for Parkinson’s disease and virtually all
patients receive it, together with a levodopa degradation inhibitor (usuallycarbidopa). When administered through the oral route, however, levodopa plasma
concentrations undergo sharp fluctuations reaching high peaks and low troughs that
contribute to the clinical and motor complications in Parkinson’s patients. Inadvanced Parkinson’s disease patients, oral levodopa therapy becomes ineffective,
leaving patients with limited treatment options that are highly invasive and/orburdensome such as deep brain stimulation or intra-duodenal levodopa/ carbidopa
gel infusion.
About ND0612
ND0612 is the first liquid formulations of levodopa and carbidopa to be administeredsubcutaneously to conveniently achieve steady state levodopa plasma levels.
Levodopa and carbidopa are nearly always administered orally and suffer from an
unfavorable pharmacokinetic profile associated with this administration route.
ND0612 is a novel approach designed to improve the drugs’ pharmacokinetic profileand maintain stable, therapeutic levodopa plasma concentrations, thereby
significantly ameliorating motor fluctuations and non-motor complications in
Parkinson’s disease.

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