SteadyMed Submits New Drug Application for Trevyent®
June 30 2017 - 2:35PM
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.
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 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.
Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
The Ruth Group
Lee Roth
(646) 536-7012
lroth@theruthgroup.com
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