SteadyMed Announces Public Availability of PTAB Decision to Institute Inter Partes Review Proceedings
April 28 2016 - 11:46AM
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 the Decision to Institute the Inter
Partes Review (IPR) proceeding against U.S. Patent No. 8,497,393
(the '393 patent), owned by United Therapeutics (Nasdaq:UTHR), is
now publicly available. This patent relates to a process to further
purify prostacyclin derivatives, such as treprostinil.
Treprostinil is the active pharmaceutical ingredient used
in United Therapeutics' Remodulin® and SteadyMed's lead
drug candidate, Trevyent®, for the treatment of Pulmonary Arterial
Hypertension (PAH).
The Institution Decision can now be found on the
web site, https://ptabtrials.uspto.gov, of the Patent Trial and
Appeal Board (PTAB) of the United States Patent and Trademark
Office (USPTO) under the case number IPR2016-00006, Document No.
17.
This redacted Institution Decision states that PTAB
has "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.
“We are pleased that the details of PTAB’s
institution of the IPR, as well as their conclusions, are now
publicly available and we are optimistic of a favorable
conclusion,” said Jonathan Rigby, President & CEO of SteadyMed.
“We look forward to submitting our New Drug Application (NDA) for
Trevyent later this year. If approved, we believe Trevyent will be
a very meaningful drug product for patients struggling with
PAH.”
On 20 April, SteadyMed hosted an Analyst and
Investor reception, where Fernando Torres, M.D., Professor of
Medicine at UT Southwestern Medical Center and Director of the Lung
Transplant and Pulmonary Hypertension Programs at Clements
University Hospital provided an insightful presentation on PAH and
the therapies used to treat it. Jonathan Rigby provided a corporate
overview of SteadyMed and discussed the IPR. An audio webcast and
copies of the presentations can be found on the Investor Relations
page of www.steadymed.com
About SteadyMed
SteadyMed Ltd. is a specialty pharmaceutical
company focused on the development of drug product candidates 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). PatchPump is a
proprietary, disposable, parenteral drug administration platform
that is prefilled and preprogrammed at the site of manufacture.
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 concerning the potential outcome of inter partes
review of U.S. Patent No. 8,497,393, the company's ability to
advance its development-stage product candidates, including
Trevyent, statements about the potential benefits of our
development-stage product candidates and our PatchPump technology,
and statements about our ability to obtain and maintain regulatory
approval of our development-stage product candidates.
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 outcome of inter partes review
of U.S. Patent No. 8,497,393, the risk that Trevyent does not
demonstrate clinical superiority to existing parenteral
treprostinil products, that Trevyent is not approved for
commercialization by the FDA 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 Annual Report on Form 10-K filed
March 29th, 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.
Contacts:
Marylyn RigbySenior Director, Investor Relations
and Marketing925-272-4999mrigby@steadymed.com
The Ruth Group David
Burkedburke@theruthgroup.com(646) 536-7009
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