Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension (PAH) is a life threatening, progressive disease caused by narrowing or tightening (constriction) of the pulmonary arteries, which connect the right side of the heart to the lungs.

There is no cure for PAH, and it worsens over time. The most common symptoms associated with the disease include breathlessness, fatigue, weakness, angina, syncope, and abdominal distension.

PAH disease progression dictates pharmacologic intervention. While treatment patterns vary, and therapies are tailored to meet an individual patient's needs, the typical progression of drug therapy will incorporate parenteral compounds in more advanced stages of the disease. Prostacyclin based therapy is currently the only parenteral option approved for use for the management of PAH.

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Treprostinil is the only parenteral treatment for PAH that is approved by the FDA for both intravenous (IV) and subcutaneous (SC) administration. Trevyent is an investigational drug product not approved for use in any jurisdiction. The current delivery systems for parenteral treprostinil are multi-component and rather complex.

Treprostinil delivered via the PatchPump technology is branded by SteadyMed as Trevyent™. Trevyent is a small, discreet, single-use (2 day) PatchPump. It is pre-filled with treprostinil and pre-programed at the correct delivery rate. PatchPump is equipped with sensors to provide patients audible and visual feedback on successful delivery and end of dosing.

We believe that Trevyent offers several benefits compared to other parenteral delivery methods, and that it has the potential to become a preferred delivery option for patients and physicians. In a recent market research study commissioned by SteadyMed, 90% of PAH treating clinicians and specialty nurses interviewed indicated a strong preference for Trevyent over existing treatment options. Additionally, 55% of the respondents gave Trevyent the highest rating possible in this study.

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. If you have interest in licensing Trevyent for commercialization in other countries, please let us know.

Trevyent is a development stage product that is not currently approved for sale by the US FDA.

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