SAN RAMON, Calif., Jan. 05, 2016 (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 the granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead product development candidate, Trevyent®, a combination of the company’s PatchPump and treprostinil, for the treatment of pulmonary arterial hypertension (PAH). Importantly, the granting of Orphan Drug Designation demonstrates that Trevyent has the potential for clinical superiority over existing treprostinil PAH treatments such as Remodulin, the market leading parenteral prostacyclin sold by United Therapeutics.
“I am very pleased that Trevyent has been granted Orphan Drug Designation by the FDA for the treatment of PAH,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “Both parenteral and inhaled treprostinil have previously been granted Orphan Drug Designation so I believe that this achievement supports our expectation that Trevyent, if approved, may offer a meaningful contribution to patient care compared to other oral, inhaled and parenteral prostacyclin treatments for PAH.”
The FDA's Orphan Drug Designation program grants orphan status to drugs intended for the treatment of rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation means Trevyent may be eligible for certain benefits, including tax credits for clinical research costs, and a waiver of the Prescription Drug User Fee Act (PDUFA) filing fees. Of significant note, Trevyent may also receive a seven-year period of U.S. marketing exclusivity upon approval, which may potentially block other treprostinil based products from coming to market.
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). 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 benefits of orphan drug designation, 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 risk that Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that Trevyent is not approved for commercialization by the FDA, that Trevyent is not granted orphan drug exclusivity, 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 most recent Quarterly Report on Form 10-Q filed on November 12, 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.
Director, Investor Relations and Marketing
Robert H. Uhl
Source: Steadymed Therapeutics