×

SteadyMed Announces Initiation of Inter Partes Review Proceedings by U.S. Patent and Trademark Office Against a United Therapeutics Patent

SAN RAMON, Calif., April 11, 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 Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has initiated an inter partes review (IPR) proceeding against U.S. Patent No. 8,497,393 (the '393 patent) owned by United Therapeutics (Nasdaq:UTHR). 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 initiation of this IPR by PTAB is a significant decision in favor of SteadyMed. While we have an appreciation for the patent process in the U.S., we believe that the patent in question is invalid. We are pleased that the PTAB, by its action to institute the formal review process, appears to believe that there is sufficient doubt about the validity of certain claims of the ‘393 patent,” stated Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “We look forward to submitting our New Drug Application (NDA) for Trevyent, which has been granted Orphan Designation, later this year. We are eager to see patients benefit from Trevyent, if approved, we have begun early preparation work for commercialization and believe that we will make significant in-roads to the PAH market.”

Statistics on IPRs report that from 2012-2015, for cases decided by final decision after institution, 74% were resolved by finding all claims unpatentable, cancelling all claims and rendering the patent invalid, 14% were resolved by finding some claims unpatentable and cancelling those claims and 12% were resolved by finding all claims patentable with the patent remaining valid.

SteadyMed will hold an Analyst and Investor reception on April 20th, 2016 from 8a.m.-10.a.m. at the Lotte New York Palace, New York City.

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, will make an informative presentation on Pulmonary Arterial Hypertension and the therapies used to treat it. Jonathan Rigby, President and CEO of SteadyMed, Ltd. will provide a corporate update and overview of Trevyent®; a Pre-NDA stage drug product being developed to create a wave in the Pulmonary Arterial Hypertension market.

Attendance is by invitation only and space is limited - To pre-register for the event, please contact David Burke of The Ruth Group at dburke@theruthgroup.com, or call 646-536-7009.

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