SteadyMed Provides Update on IPR Hearing
December 05 2016 - 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 provided an update regarding its
ongoing Inter Partes Review (IPR), challenging U.S. Patent No.
8,497,393 (the '393 patent) owned by United Therapeutics before the
Patent Trial and Appeal Board (PTAB) of the United States Patent
and Trademark Office (USPTO).
The ‘393 patent relates to a product made by a
process to purify prostacyclin derivatives, such as treprostinil,
the active pharmaceutical ingredient used in United Therapeutics'
Remodulin® and SteadyMed's lead drug candidate, Trevyent®. Upon
institution of the IPR, in April 2016, the PTAB stated that it had
"reviewed SteadyMed’s evidence, arguments, and claim charts” and
concluded that “for the foregoing reasons we determine that the
information presented in the Petition establishes that there is a
reasonable likelihood that SteadyMed would prevail in challenging
claims 1–22 of the ’393 patent”. Claims 1-22 constitute all the
claims of the ‘393 patent. The April 2016 initiation decision can
be found on the PTAB web site, https://ptabtrials.uspto.gov, under
the case number IPR2016-00006, Document No. 17.
On November 29, 2016, SteadyMed and United
Therapeutics attended an oral hearing at the USPTO. Both parties
presented their demonstratives and answered questions from the
judges in attendance. The demonstratives can be viewed at
ptab.uspto.gov by entering 2016-00006 in the AIA Review Number box
and downloading exhibits 1029 and 2061. A written transcript of the
hearing is expected to be posted to the USPTO website in the coming
weeks.
“We remain pleased with the progress of the IPR
and remain optimistic of a favorable conclusion,” said Jonathan
Rigby, President & CEO of SteadyMed. “We look forward to a
final decision from the PTAB in April 2017.”
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, and the risk that drug development
involves a lengthy and expensive process with uncertain outcome.
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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