REHOVOT, Israel, April 22, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that the Company has been informed by Canè S.p.A., the third party manufacturer of the infusion pumps used to deliver ND0612 in its current clinical trials, that they have been removed from the list of companies under import alert. This latest regulatory action by the U. S. Food and Drug Administration (FDA), dated April 21, 2016, means that normal shipments to the US of devices from this manufacturer can now be resumed.
This import alert was enacted in July of 2015 when Canè S.p.A was issued a Warning Letter by the FDA requesting the manufacturer to provide additional documentation pertaining to good manufacturing practices of the Quality System regulation. The manufacturer’s corrective actions and response to this Warning Letter have now been determined by the FDA to be apparently adequate, leading to the lifting of the import alert. A Warning Letter close-out letter will be issued only after an FDA follow-up inspection will successfully verify that corrective actions have been implemented. The timing of such inspection has yet to be determined.
NeuroDerm’s clinical development plan remains on track with its previously announced timelines both in the US and EU.
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.
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.
Oded S. Lieberman, PhD MBA, CEO
Tel.: +972-8-946 2729
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Lazar Partners Ltd.