SAN RAMON, CA--(Marketwired - June 04, 2014) - SteadyMed Therapeutics Inc., a Specialty Pharmaceutical company focused on the use of its platform technology to develop drug products to treat underserved medical needs in orphan and high value disease states, today announced that the company has raised $19.6 million in a private placement of SteadyMed Ltd (SteadyMed) preferred stock.
Proceeds from the financing will be used to complete required development and qualification activities to support the planned NDA submission for the company's lead product -- Trevyent™, in the second half of 2015, and the build out of outsourced manufacturing capabilities. The investment comes from current investors KB Partners and Samson Ventures as well as new investment from high net worth individuals and private funds.
"We are very pleased to close this $19.6 Million of our cumulative $43 Million in financing," said Jonathan M.N. Rigby, President and Chief Executive Officer. "SteadyMed has made solid progress over the past twelve months on our strategy to develop and commercialize our own PatchPump™ enabled drug product to treat the orphan disease Pulmonary Arterial Hypertension. Consistent with our progress, we have substantially strengthened and expanded our management team in key areas. We have met with FDA and received clear and positive guidance on the registration pathway to NDA submission. Our primary development program remains on track with the recent finalization of product design and selection of industrialization partners for commercial supply. We are delighted to have the support of our current and new investors."
SteadyMed Ltd., with offices in San Ramon, CA and Rehovot, Israel, is a private, venture funded Specialty Pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. These drug products will be approved via the 505(b)(2) regulatory pathway, leading to commercialization by a targeted SteadyMed sales and marketing infrastructure.
Trevyent is not approved for sale by the FDA; it is a development stage drug product that uses SteadyMed's PatchPump to administer treprostinil, a vasodilatory prostacyclin analogue to treat Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant PatchPump.
PatchPump is not approved for sale by the FDA; it is a novel, compact, prefilled, preprogrammed, disposable, parenteral drug delivery platform.