SteadyMed Receives Favorable Ruling from U.S. Court of Appeals for the Federal Circuit
November 14 2017 - 09:56AM
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 United States Court of Appeals for
the Federal Circuit affirmed a March 31, 2017, ruling by the Patent
Trial and Appeal Board (PTAB) of the United States Patent and
Trademark Office (USPTO), invalidating U.S. Patent No. 8,497,393
(the '393 patent) owned by United Therapeutics (Nasdaq:UTHR).
The case, United Therapeutics Corporation v.
SteadyMed Ltd. (Appeal No. 17-2121) was filed by United
Therapeutics on June 1, 2017, and sought to reverse the earlier
decision by the PTAB, which found that all 22 claims in the ‘393
patent were invalid, and therefore, cancelled them. The '393 patent
claimed a prostacyclin-derivative product, treprostinil, or
treprostinil salts, made by a particular process. Treprostinil is
the active pharmaceutical ingredient used in United Therapeutics'
Remodulin® and SteadyMed's lead drug candidate, Trevyent®, which is
in development for the treatment of Pulmonary Arterial Hypertension
(PAH).
The invalidity decision will preclude United
Therapeutics from asserting the '393 patent prior to SteadyMed's
launch of its Trevyent product. Moreover, because the '393 patent
has now been invalidated by the appeals court, FDA regulations
require that United Therapeutics "promptly notify FDA to…withdraw
the patent" from the FDA's "Orange Book." Once a patent is removed
from the Orange Book, neither 505(b)(2) NDA applicants such as
SteadyMed, nor generic ANDA applicants for copies of Remodulin will
be required to submit a patent certification to that patent in
their applications.
“We are very pleased with the court’s decision
to uphold the PTAB’s earlier ruling on the ‘393 patent,” said
Jonathan M.N. Rigby, President & CEO of SteadyMed. “Once again,
this reaffirms our assertion that the claims of the patent were
invalid and unpatentable.”
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’s investigational drug product candidate, Trevyent, is
designed to address a number of unmet needs in the treatment of
pulmonary arterial hypertension (PAH). Trevyent combines
SteadyMed’s preservative-free, treprostinil formulation with its
proprietary PatchPump®, which, if approved by the U.S. Food and
Drug Administration (FDA), will offer PAH patients a sterile,
pre-filled, pre-programmed, single-use, disposable infusion system
for parenteral treprostinil administration.
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, pending regulatory approvals.
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 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 when the Trevyent NDA is
resubmitted it 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 November 13, 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 Group Lee Roth(646) 536-7012lroth@theruthgroup.com
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