SAN RAMON, Calif., May 02, 2017 (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 it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application number 14/384,152, related to its PatchPump infusion system for injectable drugs. This additional patent includes, but is not limited to, claims for a pump assembly comprising a sealed, prefilled drug reservoir for the infusion of drugs.
SteadyMed’s PatchPump technology will initially be used as the infusion system for the Company’s lead, preservative free, drug product candidate Trevyent, that is in development for the treatment of pulmonary arterial hypertension (PAH). SteadyMed expects to submit its New Drug Application (NDA) for Trevyent to the U.S. Food and Drug Administration (FDA) in the second quarter of 2017.
“The grant of this patent potentially further protects not only Trevyent, but our proprietary PatchPump, prefilled, pre programmed, sterile and disposable infusion system,” said Jonathan Rigby, President & CEO of SteadyMed. “This is another significant patent to add to our robust intellectual property portfolio, which also includes Orphan designation for Trevyent, and we expect it will further strengthen our anticipated position in the PAH market and potentially be a barrier to entry for follow on competitive products.”
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 pre-filled, sterile, single use, disposable, PatchPump® infusion system, with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension (PAH). 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 about the company'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 Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, that Trevyent is not granted orphan drug exclusivity, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will not satisfy the milestone and other closing conditions to call the second tranche of its July 2016 private placement, that the company will continue to need additional funding, and that the company may be unable to raise capital when needed, which would force the company to delay, reduce or eliminate its product candidate development programs and potentially cease operations. There can be no assurance that the company will be able to complete the offering on the terms described herein or in a timely manner, if at all. 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 on March 29, 2017. 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.