SteadyMed Outlines Strategic Goals and Priorities for 2017 and Provides Update on Trevyent Launch Plans
January 09 2017 - 8:30AM
SteadyMed Therapeutics 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 updates to its key
strategic goals and its priorities for 2017.
They include:
- Filing of a New Drug Application (NDA) for Trevyent® for the
treatment of Pulmonary Arterial Hypertension (PAH) in Q2.
- Obtaining a favorable ruling in our Inter Partes Review (IPR)
challenge against U.S. Patent No. 8,497,393 (the '393 patent) owned
by United Therapeutics Corporation in early Q2.
- Subject to the granting of Priority Review of the NDA for
Trevyent, obtaining approval for commercial sale of Trevyent by the
U.S. Food and Drug Administration (FDA) in Q4.
- Subject to approval of Trevyent, obtaining Orphan Exclusivity
from the FDA and securing seven (7) years of market
exclusivity.
- Continuing to create awareness of PAH via our BePhenomenal
pulmonary hypertension community support program. Please visit
www.BePhenomenal.com for more information.
“2017 is expected to be a pivotal year for
SteadyMed as we focus our resources on key strategic goals and
priorities related to the approval of our lead drug product
candidate Trevyent,” said Jonathan Rigby, President & CEO of
SteadyMed. “We are confident that we can execute on these
initiatives and priorities. With our existing cash, plus the $10.7
million that is callable upon achievement of certain milestones per
the second tranche of our last private financing, we can fund
operations for at least the next twelve months. We are now eagerly
looking forward to the commercial launch of Trevyent, if approved,
in 2018.”
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 PatchPump® technology
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 StatementsThis
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
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 Trevyent is not approved for
commercialization by the FDA, 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 does not receive a favorable ruling in its IPR challenge,
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. 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 14, 2016. 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.
Contact:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
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