SteadyMed Receives Notice of Allowance for its European Patent Relating to Enhanced Reduction of Infusion-Site Pain

SAN RAMON, Calif., Oct. 12, 2017 -- 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 European Patent Office for Patent Application No. 13720085.3 related to enhanced infusion-site pain reduction for drug delivery devices.

“Currently, infusion-site pain is a common patient complaint when certain therapeutic drugs are delivered subcutaneously,” said Jonathan M.N. Rigby, President & CEO of SteadyMed. “The patent application relates to the delivery of a topical anesthetic, or other pain reducing drug, via the underside of our PatchPump infusion system, at the same time a therapeutic drug is delivered subcutaneously. The aim of this approach is to effect a reduction in infusion-site pain caused by the therapeutic drug. This is another significant patent to add to our robust intellectual property portfolio.”

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. SteadyMed’s investigational drug product candidate, Trevyent®, is designed to address a number of unmet needs in the treatment of pulmonary arterial hypertension (PAH). Trevyent combines SteadyMed’s preservative-free, treprostinil formulation with its proprietary PatchPump®, which, if approved by the U.S. Food and Drug Administration (FDA), will offer PAH patients a sterile, pre-filled, pre-programmed, single-use, disposable infusion system for parenteral treprostinil administration.

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, pending regulatory approvals. 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 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 when the Trevyent NDA is resubmitted it is not accepted for filing by the FDA, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, the risk that drug development involves a lengthy and expensive process with uncertain outcome, 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. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q filed on August 11, 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.

Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
[email protected]

The Ruth Group
Lee Roth
(646) 536-7012
[email protected]