No clinical trials required for NDA resubmission
SAN RAMON, Calif., Dec. 08, 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 it has received final minutes from the US Food and Drug Administration (FDA) on the work necessary to resubmit its New Drug Application (NDA) for Trevyent® for the treatment of Pulmonary Arterial Hypertension (PAH).
The minutes followed a positive and collaborative Type A meeting with the FDA on November 1, 2017. The FDA is not requiring SteadyMed to conduct any clinical trials to prove the safety or efficacy of Trevyent and has agreed that a repeat of in vitro Design Verification (DV) testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and Process Validation, should be adequate for the resubmission and acceptance of the 505(b)(2) New Drug Application (NDA).
The purpose of in vitro DV testing is to confirm that Trevyent performance meets its design specifications. The testing is designed to confirm product performance under various conditions on the final, to-be-marketed, Trevyent product. SteadyMed has begun the pre-DV activities, which precede the DV testing, with Trevyent performance data being available around mid 2018. SteadyMed expects both NDA submission and acceptance to occur before the end of 2018. SteadyMed ended Q3 2017 with a strong cash position of $37.4M, providing more than sufficient capital to fund operations through the NDA resubmission and acceptance.
“We are very pleased with the outcome of our meeting with FDA, we have clarity on the work that needs to be done and are confident that our agreed path forward will lead to a resubmission and acceptance for filing of the Trevyent NDA,” said Jonathan M. N. Rigby, President and CEO of SteadyMed. “We continue to strongly believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and we remain committed to bringing the product to patients in need.”
Designed to address the limitations of existing PAH therapies, SteadyMed’s investigational drug product Trevyent, combines its preservative-free, parenteral treprostinil formulation with the Company’s proprietary PatchPump®. Trevyent is a sterile, pre-filled, pre-programmed, single use disposable infusion system that is in development for the initial indication of continuous subcutaneous infusion of treprostinil for the treatment PAH.
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. SteadyMed intends to commercialize Trevyent in the U.S. and has granted an exclusive license 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 intentions to meet with the FDA and re-submit its New Drug Application for Trevyent and the company’s ability to advance its development-stage product candidates, including 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 Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that the Trevyant NDA is not accepted for filing by the FDA, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, the risk that drug development involves a lengthy and expensive process with uncertain outcome, 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. 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 November 13, 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