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SAN RAMON, Calif., Dec. 05, 2016 -- 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 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 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 [email protected]
