SAN RAMON, Calif., May 7, 2015 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY) a specialty pharmaceutical company, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its lead drug product candidate, Trevyent, for the treatment of pulmonary arterial hypertension (PAH). The FDA has acknowledged receipt of the application and will notify SteadyMed when the review process is completed. If granted, Orphan Drug Designation in the U.S. would qualify Trevyent for various development incentives such as tax credits, waiver of New Drug Application (NDA) submission fees, possibility for a priority review upon filing of its NDA submission, and potentially a 7-year period of marketing exclusivity after NDA approval is granted.
"SteadyMed continues to execute on our strategic goals including our submission of this request for Orphan Drug Designation," said Jonathan M. N. Rigby, President and CEO of SteadyMed. "We look forward to a decision from the FDA as we continue to drive to submission of an NDA for Trevyent in the first quarter of 2016."
Orphan Drug Designation can be granted by the FDA for drug or biological products that are intended to treat rare diseases, defined as affecting fewer than 200,000 individuals in the U.S. Orphan Drug Designation may also be granted for drug or biologic products that demonstrate clinical superiority over an already approved drug used to treat an orphan disease. PAH is a rare, progressive, life-threatening disease that can eventually lead to heart failure and premature death. Approximately 30,000 patients in the U.S. are currently diagnosed with PAH.
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. PatchPump is a proprietary, disposable, parenteral drug administration platform that is prefilled and preprogrammed at the site of manufacture. SteadyMed has offices in San Ramon, California and Rehovot, Israel.
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 company's ability to advance its development-stage product candidates, including the potential benefits of Orphan Drug Designation if granted to 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 Prospectus which was declared effective on March 19, 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.