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Press Release

NeuroDerm to Present ND0612 Data at 4th World Parkinson Congress Demonstrating Ease of Use of Mini-Pump Delivery System

Posted on: 19 Sep 16

REHOVOT, Israel, Sept. 19, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced that the Company will present previously unreported human factors data from a usability study focused on the interactions between Parkinson’s disease patients and the mini-pump device used to administer ND0612, the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation. The data will be presented at the 4th World Parkinson Congress (WPC) taking place in Portland, Oregon, on September 20-23.

Tamar Rachmilewitz, M.D., Medical Director at NeuroDerm, will present the data in a poster titled, “ND0612 – a newly developed liquid levodopa/carbidopa formulation administered continuously subcutaneously by a mini-pump – patient use perspective,” (Abstract P31.16). The poster will be presented in the Clinical Sciences: Pharmacological Therapy session to be held 11:30 a.m. – 1:30 p.m. PT on September 22.

NeuroDerm will be exhibiting at booth #823 throughout the WPC and will have information available to Parkinson’s patients and physicians regarding the ongoing clinical trials of ND0612, the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation administrated through a mini-pump device, which recently began enrolling patients in the U.S.

Four additional abstracts containing previously reported data will also be presented during the conference:

  • “ND0701: a novel safe concentrated apomorphine formulation for continuous subcutaneous administration via a patch pump (Abstract P31.18).”
  • “Stable levodopa plasma levels with ND0612 (levodopa/carbidopa for subcutaneous infusion) in Parkinson’s disease (PD) patients with motor fluctuations (Abstract P35.02, trial 003).”
  • “Pharmacokinetic profile of ND0612L (levodopa/carbidopa for subcutaneous infusion) in patients with moderate to severe Parkinson’s disease (Abstract P35.13, trial 004).”
  • “A randomized controlled clinical study to evaluate the efficacy and safety of subcutaneous levodopa/carbidopa (ND0612H) in patients with advanced Parkinson’s disease (Abstract P35.12, trial 006).”

“NeuroDerm's novel therapies are designed to give back to advanced Parkinson's patients the control that they lost over their lives. It is important to demonstrate that Parkinson’s disease patients and/or their caregivers can use the ND0612 mini-pump correctly with minimal training. We look forward to presenting the results of the human factors study of the current administration set at this conference, as we believe that these data support our expectations that ND0612 may be readily adopted by advanced Parkinson's patients thereby transforming their lives," said Oded S. Lieberman, PhD, CEO of NeuroDerm.  

About ND0612H and ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD solution. Previously completed Phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including "off time" reductions when added to optimal oral standard of care.  ND0612H, intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.

About Parkinson's disease
Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions.  Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life.  Levodopa is the most effective treatment for Parkinson’s disease.  However, chronic oral levodopa treatment is associated with fluctuations in motor response as result of which, despite the benefits of the drug, patients can experience periods of impaired motor and non-motor functions, also referred to as "off" time.  In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia.  The "off" time and dyskinesia affect the majority of levodopa-treated Parkinson's disease patients and can interfere with day-to-day functions, causing patients to become severely disabled.  Current evidence suggests that intermittent dosing with standard oral formulations of levodopa contributes to the development of these motor complications.  By contrast, it has been shown that continuous administration of levodopa can effectively treat motor fluctuations in Parkinson's disease patients without increasing troublesome dyskinesia; however, a convenient route for continuous administration has not been introduced to date.

About the World Parkinson Coalition® and WPC 2016
The World Parkinson Coalition Inc. is a nonprofit organization that provides an international forum for learning about the latest scientific discoveries, medical practices, care partner initiatives and advocacy work related to Parkinson's disease. The World Parkinson Coalition® launched the first Congress in 2006 to provide a space for the global Parkinson’s community of researchers, clinicians, health care professionals, people with Parkinson’s and their care partners to meet in person, network and to share advances in Parkinson’s research, improve understanding and promote advocacy worldwide, and to potentially shape future research, treatment and care.

About NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration.  The company has three product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease.  The company has developed a line of levodopa and carbidopa (LD/CD) product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD.  The LD/CD product candidates are ND0612L and ND0612H, which are used for treatment of moderate and advanced Parkinson’s disease patients, respectively, and which are delivered subcutaneously.  In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from moderate to severe Parkinson’s disease and who do not respond well to LD/CD.  NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.

Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2015 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

NeuroDerm Contact:
Oded S. Lieberman, PhD, CEO
Tel.: +972-8-946 2729; Cell: +1-617-517 6077

U.S. Investor Contact:
David Carey
Lazar Partners Ltd.

U.S. Media Contact:
Erich Sandoval
Lazar Partners Ltd.


Last updated on: 20/09/2016

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