SAN RAMON, Calif., April 14, 2016 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a pre-NDA stage 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 it will hold an Analyst & Investor day:
Date: Wednesday, April 20, 2016
Time: 8:00 – 10:00 a.m. ET
Breakfast: 7:30 a.m.
Location: Lotte Palace Hotel, New York, NY
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 (PAH) and the therapies used to treat it. Jonathan Rigby, President and CEO of SteadyMed, Ltd. will provide a corporate update and overview of Trevyent®, the company's lead drug product candidate being developed to treat PAH, which has received Orphan Designation and with an NDA submission anticipated in Q4 2016.
Mr. Rigby will also discuss the recent announcement 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). The PTAB has preliminarily agreed with SteadyMed’s arguments concerning invalidity, and has initially found that there is a reasonable likelihood that SteadyMed would prevail in challenging the ‘393 patent.
Space is limited: To pre-register for the event, please contact David Burke of The Ruth Group at firstname.lastname@example.org, or call 646-536-7009.
An audio webcast and archive of the presentation will be available through the Events and Presentations page of the company's corporate website (www.steadymed.com) on April 21, 2016.
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 29, 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.
Source: SteadyMed Therapeutics