SteadyMed Demonstrates Potential for Reduced Infusion Site Sensitivity Associated With Trevyent Compared to Remodulin

SteadyMed Ltd., a specialty pharmaceutical company focused on the development of drug products to treat orphan and high-value diseases with unmet parenteral delivery needs, recently announced the results of a non-clinical animal study, which evaluated the potential effect of the company’s preservative-free Trevyent(R) formulation on reducing the significant subcutaneous infusion site pain often associated with United Therapeutics’ Remodulin(R), the market leading prostacyclin used to treat pulmonary arterial hypertension.

Trevyent is a development-stage drug product candidate not yet approved by the FDA that is a combination of SteadyMed’s PatchPump(R) and treprostinil formulated without the preservative meta-cresol. Remodulin is supplied in a multi-dose vial that contains treprostinil and by necessity the preservative meta-cresol.

“The results of this preclinical investigation support the findings in the scientific literature regarding the adverse effect of local site pain associated with injection products containing the preservative meta-cresol,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “Severe infusion site pain affects more than 80 percent of patients with PAH taking subcutaneous Remodulin, with an estimated 30 percent resorting to narcotic pain relievers in order to continue treatment. We believe Trevyent’s preservative-free formulation, if approved, has the potential to reduce the prevalence or severity of infusion site pain for PAH patients, and we look forward to confirming these results in future clinical studies.”

Formulations representative of Trevyent and Remodulin were tested in an animal model via continuous subcutaneous infusion for 7 days. Tactile sensitivity, an indicator of local site pain, was evaluated using a variety of endpoints on Day 1 (baseline), on Day 3 and on Day 7. The results from testing with an Electronic Von Frey probe, relative to baseline and placebo-corrected, showed a significant reduction in skin pain sensitivity with SteadyMed’s preservative-free drug formulation compared to the drug formulation with preservative, representative of Remodulin.

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(R), 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 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.

CONTACT: Marylyn Rigby, Director, Investor Relations & Marketing, 925-272-4999, mrigby@steadymed.com