Company on Track for Launch in Mid 2018, Subject to FDA Approval
SAN RAMON, Calif., June 30, 2017 (GLOBE NEWSWIRE) -- 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 submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead drug product candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension (PAH).
“The submission of our NDA for Trevyent is the latest in a series of significant milestones and accomplishments for SteadyMed thus far in 2017, and we are delighted that we are one major step closer to potentially making Trevyent available to patients suffering from PAH,” said Jonathan M. N. Rigby, President and CEO of SteadyMed. “PAH is a serious, life threatening disease, and currently, the administration of high dose prostacyclins to help these patients has some serious challenges. Our drug product candidate, Trevyent, has been developed with the aim of addressing these challenges and we look forward to launching it in mid 2018, subject to FDA approval.”
Designed to address the limitations of existing PAH therapies, Trevyent combines SteadyMed’s preservative-free, parenteral treprostinil formulation with the Company’s proprietary PatchPump, in a sterile, pre-filled, pre-programmed, single use disposable infusion system capable of delivering treprostinil subcutaneously or intravenously.
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 pre-filled, sterile, single use, disposable, PatchPump® infusion system, 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 about the company's ability to advance its development-stage product candidate Trevyent, the potential benefits of Trevyent and the market opportunity for Trevyent. 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 the Trevyent NDA is not accepted for filing by the FDA, the risk that Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, the risk that the NDA is assigned a standard review designation which would delay FDA’s decision until mid-2018, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, that the proposed proprietary name Trevyent is rejected and any goodwill associated with that name is lost, that Trevyent is not granted orphan drug exclusivity, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will not satisfy the milestone and other closing conditions to call the second tranche of its July 2016 private placement, that the company will continue to need additional funding, and that the company may be unable to raise capital when needed, which would force the company to delay, reduce or eliminate its product candidate development programs and potentially cease operations. There can be no assurance that the company will be able to complete the offering on the terms described herein or in a timely manner, if at all. 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 May 12, 2017. 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.
Senior Director, Investor Relations and Marketing
The Ruth Group