NeuroDerm (NDRM) Will Require Additional Time to Activate BeyoND Clinical Sites in Certain Countries

September 29, 2016 7:02 AM EDT

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NeuroDerm Ltd. (Nasdaq: NDRM) announced that the Company requires additional time to activate clinical sites in certain countries that are participating in its long-term safety trial (trial 012, the "BeyoND" trial) of ND0612, the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation. As previously disclosed, upon the completion of the BeyoND trial, as well as the other parallel trials outlined in the Company’s clinical development plan, NeuroDerm intends to submit marketing applications in the U.S. and the EU for ND0612.

Based on the additional time needed for the BeyoND trial, the Company currently expects to submit such marketing applications in the first half of 2018 rather than in the end of 2017, as previously expected. The timeline for product approval could be shortened if the Company applies for, and is granted, an accelerated approval process.

The BeyoND trial is expected to enroll approximately 100 patients. Institutional Review Board (IRB) approval and patient enrollment rates for this trial are proceeding as anticipated in currently active sites.

“We are committed to making our ND0612 product candidates available to Parkinson’s disease patients in need of new therapeutic options. Toward that end, we are expanding the number of countries that will participate in this study as well as the number of U.S. participating sites in order to ensure that we are able to enroll all 100 patients as quickly as possible,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We feel confident that the addition of these sites will allow us to meet the trial’s enrollment target on a timeline that will support submission of regulatory applications in the U.S. and EU in the first half of 2018.”

The Company’s cash guidance remains unchanged, and NeuroDerm believes that it has sufficient cash to advance its product pipeline as planned and reach its clinical and regulatory milestones through mid-2018.

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