NeuroDerm Announces Eligibility for European Union Centralized Procedure for ND0612H, a Novel Treatment for Advanced Parkinson’s Disease
REHOVOT, Israel (August 4, 2014) — NeuroDerm Ltd. today announced that the European Medicines Agency (EMA) has deemed ND0612H, its product candidate offering continuous delivery of levodopa/carbidopa (LD/CD) treatment for advanced Parkinson’s disease, eligible for a European Union marketing authorization application procedure (“centralized procedure”). According to EMA guidelines, the EMA can allow products for which the centralized procedure is not mandatory to use that procedure, if the EMA considers that it constitutes a significant therapeutic, scientific or technical innovation.
ND0612H is a high-dose form of liquid LD/CD drug delivered continuously through subcutaneous administration by a belt pump. ND0612H is designed to significantly reduce motor complications in advanced Parkinson’s disease patients by maintaining steady, high levodopa plasma levels in a convenient manner, to replace current treatments that require highly invasive surgery associated with serious side effects.
“The eligibility for the centralized procedure in the European Union confirms the innovation underlying ND0612H,” said Oded Lieberman, PhD, NeuroDerm’s CEO. “It also means that ND0612H will be able to benefit from the more streamlined access to the EU market inherent in this regulatory route. NeuroDerm wishes to bring ND0612H into the market as quickly as possible and make a dramatic change in the lives of Parkinson’s disease patients.”
ND0612L, NeuroDerm’s low dose drug form for moderate stage Parkinson’s patients, has successfully completed Phase I and IIa studies. It is currently undergoing a Phase II double-blind, randomized, placebo-controlled study supported by a grant from The Michael J. Fox Foundation for Parkinson’s Research.
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 (usually carbidopa). 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. In advanced Parkinson’s disease patients, oral levodopa therapy becomes ineffective, leaving patients with limited treatment options that are highly invasive and/or burdensome such as deep brain stimulation or intra-duodenal LD/CD gel infusion.
Our product candidates, ND0612L and ND0612H, are the first liquid formulations of levodopa and carbidopa to be administered subcutaneously 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. NeuroDerm’s proprietary technology for continuous subcutaneous delivery of liquid levodopa and carbidopa is a novel approach designed to improve the drugs’ pharmacokinetic profile and maintain stable, therapeutic levodopa plasma concentrations, thereby significantly ameliorating motor fluctuations and non-motor complications in Parkinson’s disease.
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 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 LD/CD product candidates administered through small belt pumps that deliver 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.
 European Medicines Agency. 2007. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (Article 3(2)b).