NeuroDerm to Announce Updated Topline Results of ND0612L at the 67th Annual Meeting of the American Academy of Neurology
REHOVOT, Israel, April 1, 2015 — NeuroDerm Ltd. (NASDAQ:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, announced that updated results from the Phase II Study assessing the safety, tolerability and pharmacokinetics (PK) of ND0612L will be presented at the American Academy of Neurology (AAN) 67th Annual Meeting taking place April 18 to 25, 2015 in Washington, DC. ND0612L is the low-dose product candidate of NeuroDerm’s proprietary liquid Levodopa/Carbidopa (LD/CD) formulation that provides continuous, subcutaneously-delivered treatment for patients with moderate to severe Parkinson’s disease. The company previously announced positive topline results of the study at The Michael J. Fox Foundation’s 2014 Parkinson’s Disease Therapeutics Conference in October 2014. The data showed that patients with moderate to severe Parkinson’s disease who received continuous, subcutaneous doses of ND0612L exhibited clinically significant reduction in fluctuations of plasma levodopa concentrations compared to patients receiving placebo. Patients receiving ND0612L also experienced a corresponding in-clinic two-hour reduction over placebo in “off” time, improved sleep, better quality of life and global clinical improvement without an increase in troublesome dyskinesia. The poster (P1.187), “Pharmacokinetics and Safety of ND0612L (LD/CD for Subcutaneous Infusion): Results from a Phase II Study in Moderate to Severe Parkinson’s Disease,” will be on display during Poster Session I – Movement Disorders: Parkinson’s Disease Pharmacotherapy from 2:00 to 6:30 PM EDT on Monday, April 20. Lead investigator Nir Giladi, MD, Associate Professor in the Sackler Faculty of Medicine at Tel Aviv University and Chairman of the Department of Neurology at the Tel Aviv Sourasky Medical Center and Sheila Oren, MD, Vice President of NeuroDerm Clinical and Regulatory Affairs will be available to answer questions on the findings of the poster from 5:00 PM to 6:30 PM EDT. About Levodopa Oral administration of LD/CD is regarded as the “gold standard” treatment for patients suffering from Parkinson’s disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually all patients diagnosed with Parkinson’s disease will require levodopa at some point over the course of their treatment for the disease, and 70% to 80% of patients receive the drug at any given point in time. However, levodopa is limited by its short half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma. In addition, levodopa suffers from low absorption when administered orally, with only about 30% of the levodopa entering the blood stream. ND0612H, ND0612L ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson’s disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night. ND0612H is intended to provide an alternative to surgical treatments associated with serious side effects that are currently offered to patients with severe Parkinson’s disease. 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. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased 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 Parkinson’s disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson’s disease patients, however, a convenient route of continuous administration has not been introduced to date. 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. In Parkinson’s disease, the company has four product candidates which offer a solution for almost every Parkinson’s disease patient from moderate to the very severe stage of the disease. The company has developed a line of levodopa-carbidopa (LD/CD) product candidates administered through a small belt pump that delivers a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson’s disease patients, respectively, and ND0680 for a subset of severe Parkinson’s disease patients whose symptoms have advanced to a more acute stage, requiring even higher doses of LD/CD. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park, 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, 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 prospectus filed with the Securities and Exchange Commission on November 13, 2014. 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.
Oded S. Lieberman, PhD, MBA, CEO
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