SteadyMed Announces Completion of Pre-NDA Submission Manufacturing Activities
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, recently announced it has completed the manufacture of all of the Trevyent batches for shelf-life studies needed to support the submission of its NDA in the first quarter of 2017.
“Trevyent, our lead drug product candidate in development for the treatment of Pulmonary Arterial Hypertension (PAH), combines SteadyMed’s proprietary, preservative-free formulation of treprostinil and our PatchPump platform technology,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “In our latest manufacturing campaign, we have manufactured thousands of commercial Trevyent units. These units cover the concentration range of currently available Remodulin (treprostinil, United Therapeutics) and were manufactured utilizing our final commercial supply chain infrastructure, in compliance with current Good Manufacturing Practice (cGMP) standards. We are delighted with this achievement and are now forging ahead, and on track, to submit our New Drug Application (NDA) to the US FDA in Q1 2017. Given our recent private financing transaction, as further described in our second quarter 2016 Form 10-Q, we believe we have the necessary capital to launch Trevyent in the US in late 2017, if approved by the FDA.”
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs. The company’s lead drug product candidate is Trevyent, a development-stage drug product that combines SteadyMed’s PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension (PAH). SteadyMed intends to commercialize Trevyent in the US and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada, and the Middle East. SteadyMed has offices in San Ramon, CA, and Rehovot, Israel. For more information, visit www.steadymed.com.
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