SteadyMed Submits Type A Meeting Request Package to FDA
September 28 2017 - 8:30AM
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 submitted a Type A Meeting
Request and Briefing Document to the U.S. Food and Drug
Administration (FDA).
The Type A meeting is being requested in
response to the FDA’s August 28, 2017 Refusal to File (RTF) letter
relating to SteadyMed’s New Drug Application (NDA) for Trevyent®,
its lead drug product candidate that is in development for the
treatment of Pulmonary Arterial Hypertension (PAH). The Meeting
Request and Briefing Document contain SteadyMed’s proposals to
address the issues raised by the FDA in the RTF letter, along with
a request for a Type A meeting to obtain agreement on SteadyMed’s
proposed pathway to a Trevyent NDA resubmission. Per FDA guidance
to industry, a Type A meeting is a meeting needed to help an
otherwise stalled product development program proceed. If
granted, Type A meetings are generally scheduled within 30 days of
the meeting request.
“We believe that we have provided a Briefing
Document that will allow us to work collaboratively with FDA to
agree on a pathway to resubmission of our NDA for Trevyent,” said
Jonathan M. N. Rigby, President and CEO of SteadyMed. “We look
forward to meeting with FDA in the near future.”
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®, in a sterile,
pre-filled, pre-programmed, single use disposable infusion system
for parenteral delivery of treprostinil.
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
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 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 August 11,
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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