SteadyMed Announces Completion of Pre-NDA Submission Manufacturing Activities

SAN RAMON, Calif., Sept. 01, 2016 -- 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, today announced that 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 U.S. Food and Drug Administration (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 U.S. in late 2017, if approved by the FDA.”

About SteadyMed

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 U.S. 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, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others,  statements regarding the company’s anticipated NDA filing, the potential commercialization of Trevyent, the potential benefits of the company’s development-stage product candidates and PatchPump technology and the company’s anticipated liquidity. Forward-looking statements reflect the company's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the risk that Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that Trevyent is not approved for commercialization by the FDA and the risk that drug development involves a lengthy and expensive process with uncertain outcome. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q filed on August 15, 2016. The company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof except as may be required by law.

Contacts:

Marylyn Rigby 
Senior Director, Investor Relations and Marketing
925-272-4999
[email protected]

The Ruth Group
David Burke
(646) 536-7009
[email protected]