SteadyMed Therapeutics, an Israeli based specialty pharmaceutical company that focuses on the development of drug product candidates to treat rare and chronic diseases with unmet parenteral (not delivered via the intestinal tract) delivery needs, announced that they have recently filed with the US Securities and Exchange Commission (SEC) to raise $55 million in a NASDAQ IPO. The company initiated this move just ten days after raising $12.2 million in equity financing. The reported underwriters for the IPO are Wells Fargo, RBC and JP Morgan. For patients diagnosed with pulmonary arterial hypertension (PAH), whose only FDA approved drug treatment option Treprostinil consists of a complex multi-component delivery system, this is hopeful news, as SteadyMed will use the bulk of its new funding to further develop its PAH drug delivery technology.
SteadyMed was founded in 2005, and since then developed PatchPump, a novel, prefilled, size efficient and disposable subcutaneous drug delivery system. Using the patented PatchPump technology, the company has taken the current complex delivery system for Treprostinil and made it easier for patients to ensure the proper dose administration at the correct time using sensors that provide audio and visual feedback. The delivery of Treprostinil through the PatchPump is branded as Trevyent.
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SteadyMed aims to make Trevyent the preferred delivery option for PAH patients and their healthcare providers. The announcements that they have filed with the SEC and raised $12.2 million in equity financing brings them closer to being able to achieve these goals. Speaking on the importance of these announcements, Jonathan M.N. Rigby, SteadyMed’s President and Chief Executive Officer, stated: “We are very pleased to have completed this latest round of financing. This year promises to be an important time for SteadyMed as we take the necessary steps to file for regulatory approval for Trevyent, our lead drug product candidate that utilizes our proprietary PatchPump technology in combination with treprostinil to treat PAH.”
PAH defines a group of debilitating idiopathic (of unknown origin) or co-morbid conditions that cause breathlessness, loss of exercise capacity, and death due to elevated pulmonary artery pressure and subsequent right heart failure. It is a rare (orphan disease) condition affecting 1 to 2 individuals for every 1 million in the US and Europe. PAH is characterized by high blood pressure (BP) in the pulmonary arteries, which carry oxygen and blood from the heart to the lungs. In healthy individuals, pulmonary arterial pressure should be approximately 25/10 millimeters of mercury (mmHg); for patients diagnosed with PAH this pressure consistently exceeds 40/20 mmHg
With the high level of debilitation that is often a result of PAH diagnosis, having an easier and less complex drug delivery system will allow for an increase in quality of life for these patients.