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
oded@neuroderm.com
Tel.: +972-8-946 2729; Cell: +1-617-517 6077
U.S. Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
+212-867-1768
U.S. Media Contact:
Erich Sandoval
Lazar Partners Ltd.
esandoval@lazarpartners.com
+917-497-2867