U.S. Patent Trial and Appeal Board Cancels all claims in United Therapeutics’ ‘393 patent for purification of prostacyclin derivatives, rendering patent invalid.

SteadyMed plans to file New Drug Application (NDA) for Trevyent® for the treatment of Pulmonary Arterial Hypertension (PAH) in Q2 2017

SAN RAMON, Calif., March 31, 2017 (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 Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) ruled in its favor in the Inter Partes Review (IPR) proceeding against U.S. Patent No. 8,497,393 (the '393 patent) owned by United Therapeutics. In its ruling, the PTAB found all 22 claims in the '393 patent unpatentable and cancelled them, rendering the patent invalid.  

The IPR was instituted by PTAB in April 2016 after SteadyMed challenged the '393 patent's validity. The '393 patent claims a product made by 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, which is in development for the treatment of Pulmonary Arterial Hypertension (PAH).

“We are very pleased with this decision by the PTAB, which confirms our position that the claims in the '393 patent were invalid and the patent should not have been issued to United Therapeutics,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “We continue to focus on completing the final steps ahead of submitting our New Drug Application (NDA) for Trevyent, for the treatment of PAH, by the end of the second quarter. We have a growing body of market research data that we believe strongly indicates a significant need for Trevyent that, if approved, has the potential to take a meaningful share of the PAH market.”

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 or approval is delayed by patent litigation, that Trevyent is not granted orphan drug exclusivity, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will not satisfy the milestone and other closing conditions to call the second tranche of its July 2016 private placement, 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 Annual Report on form 10-K filed on March 29, 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 Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com

The Ruth Group 
Lee Roth
(646) 536-7012
lroth@theruthgroup.com

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