U.S. New Drug Application for TREVYENT® for the Treatment of Pulmonary Arterial Hypertension

 

VANCOUVER, Canada I July 3, 2017 I Cardiome Pharma Corp. (NASDAQ:CRME / TSX:COM) today announced that partner SteadyMed Ltd (NASDAQ:STDY) submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TREVYENT® (treprostinil injection). TREVYENT® is a drug-device combination product that utilizes SteadyMed's PatchPump® technology to deliver treprostinil, a vasodilatory prostacyclin analogue, for the treatment of pulmonary arterial hypertension (PAH).

PatchPump® is a proprietary, disposable, parenteral drug administration platform that is prefilled and preprogrammed at the site of manufacture. Cardiome licensed the commercial rights to TREVYENT® for many international markets in June 2015. Cardiome expects to file TREVYENT® for European Medicines Agency (EMA) and Health Canada approval by the end of 2017.

"The NDA filing with the FDA is an important step in the development of TREVYENT®, and advances us closer to our goal of bringing what we believe is a better way to deliver treprostinil to patients around the world who are suffering from PAH," said Hugues Sachot, Cardiome's Chief Commercial Officer. "Our partnership with SteadyMed continues to progress well, and we will work closely with them to file with both the EMA and Health Canada by the end of this year."

About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a type of high blood pressure that occurs in the right side of the heart and in the arteries that supply blood to the lungs. PAH worsens over time and is life-threatening because the pressure in a patient's pulmonary arteries rises to dangerously high levels, putting a strain on the heart. There is no cure for PAH, but several medications are available to treat symptoms, such as the market-leading prostacyclin PAH therapy, Remodulin® (treprostinil injection), which is produced by United Therapeutics Corporation. The annual cost of Remodulin is reported to be between approximately $125,000 and $175,000 per patient and United Therapeutics reported Remodulin revenues of $602 million in 2016.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of patients suffering from disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe, Canada, and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIB/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner Amomed in select European markets. Cardiome has also licensed: XYDALBA™ (dalbavancin hydrochloride), a second generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults for select European and Middle Eastern nations and Canada from Allergan; and TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets from SteadyMed Therapeutics.

SOURCE: Cardiome Pharma

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