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SteadyMed Announces Public Availability of PTAB Decision to Institute Inter Partes Review Proceedings

SAN RAMON, Calif., April 25, 2016 (GLOBE NEWSWIRE) -- 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 Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com

The Ruth Group
David Burke
dburke@theruthgroup.com
(646) 536-7009

Source: SteadyMed Therapeutics