SAN RAMON, Calif., Oct. 21, 2015 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that the company has filed an Inter Partes Review (IPR) with the United States Patent and Trademark Office (USPTO) to invalidate U.S. Patent No. 8,497,393 (the '393 patent) granted to United Therapeutics (Nasdaq:UTHR). The patent relates to a process to prepare prostacyclin derivatives such as treprostinil, the medicine used in SteadyMed's lead product candidate, Trevyent®, for the treatment of pulmonary arterial hypertension (PAH).
"While we have not disclosed our patent certification strategy that will be implemented at the time of our Trevyent NDA filing in Q3 2016 and we have confidence in our freedom to operate, we have decided to move forward with this additional IPR process as a proactive, time-efficient, and cost-effective step towards clearing the patent landscape based on patent invalidity," said Jonathan Rigby, President and CEO of SteadyMed. "Trevyent is unlike any treatment currently on the market for PAH and has the potential to become the preferred delivery option for the most clinically effective form of treprostinil, the only parenteral treatment for PAH that is approved by the United States Food and Drug Administration for both intravenous and subcutaneous administration. We, our legal counsel, and our retained expert in the field of organic and medicinal chemistry, strongly believe, based on the existence of significant prior art, that the '393 patent should not have been issued to United Therapeutics."
Trevyent is a combination of SteadyMed's PatchPump® technology and treprostinil that is synthesized by a proprietary, patent protected process. The company expects a decision by the USPTO to occur in advance of the anticipated product launch of Trevyent in 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 or 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 in June 2015, 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 Inter Partes Review filed by the SteadyMed Ltd. regarding U.S. Patent No. 8,497,393 and SteadyMed'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 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 most recent Quarterly Report on Form 10-Q filed on August 13, 2015. 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.