SteadyMed Therapeutics, a California-based specialty pharmaceutical company that develops drug products for treating orphan and high-value diseases with unmet non-oral delivery needs, has hired Carl Hicks, Jr. to take on the newly created role of Vice President of PH Patient Advocacy and Community Relations.
Hicks is a 20-year veteran of the fight against pulmonary hypertension (PH), and is recognized both nationally and internationally as an advocate for patients, caregivers, and the PH community, according to a company press release. He joins SteadyMed from the PH patient advocacy organization The Pulmonary Hypertension Association (PHA), where he has served as a board member since 2000, and during which he has held several executive positions, including executive vice president and chairman of the board.
“We are delighted that Carl joins us in this very important role,” said Jonathan Rigby, President & CEO of SteadyMed. “His devotion to patients and the broader PH community, as well as his rich, relevant experience will be invaluable to us as we prepare to file a New Drug Application (NDA) for Trevyent, our lead drug product candidate for the treatment of pulmonary arterial hypertension, in (the second quarter of 2017). SteadyMed is committed to building a strong relationship with this underserved patient population and meeting their needs in a meaningful and impactful manner,” Rigby said.
Trevyent combines SteadyMed’s proprietary, preservative-free formulation of the vasodilatory prostacyclin analogue drug treprostinil, delivered by the company’s PatchPump platform technology at a preprogrammed specified delivery rate to treat PAH. The PatchPump is equipped with sensors that give patients audible and visual feedback.
Treyvent was designated an Orphan Drug by the U.S. Food and Drug Administration (FDA) in January. SteadyMed plans to submit a New Drug Application (NDA) to the FDA in 2017, noting in a recent press release that a recent private financing transaction has secured the capital necessary to launch Trevyent in the U.S. market in late 2017, pending FDA approval.
“We have manufactured thousands of commercial Trevyent units. These units cover the concentration range of currently available Remodulin (treprostinil, United Therapeutics) and were manufactured in compliance with current Good Manufacturing Practice (cGMP) standards.”
SteadyMed says it intends to commercialize Trevyent in the U.S. itself, and has entered an exclusive license and supply agreement with Vancouver, Canada-based Cardiome Pharma to commercialize Trevyent in Europe, Canada and the Middle East.
“I am thrilled to join SteadyMed, a company that prides itself with a strong patient focus,” Hicks said in the prepared statement. “The loss of my daughter to PH drives me to be a fierce advocate for this devastating disease. In this role, I am committed to helping SteadyMed engage with, and address the needs of these patients who may one day benefit from Trevyent, if approved, by the Food and Drug Administration (FDA).”
Hicks’ addition to the SteadyMed team is aligned with SteadyMed Ltd’s launch last month of a new website, BePHenomenal.com, dedicated to education empowerment of people living with PH to live the healthiest and most “Phenomenal” lives possible.
PAH is a pulmonary condition in which arteries that transport blood from the heart to the lungs gradually become narrowed, inducing high blood pressure (hypertension) in the lungs due to restricted blood flow. To compensate, the heart’s right ventricle has to pump harder to move blood into the pulmonary artery, causing the heart to become enlarged and weakened, eventually so weakened that it can no longer pump blood, resulting in heart failure.