SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
December 08 2017 - 5:55AM
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.
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.
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.
Contacts:Marylyn RigbySenior
Director, Investor Relations and
Marketing925-272-4999mrigby@steadymed.com
The Ruth GroupLee Roth(646)
536-7012lroth@theruthgroup.com
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