SteadyMed Therapeutics is heading to Nasdaq in search of $55 million (€49 million) to finance its assault on United Therapeutics' ($UTHR) slice of the pulmonary arterial hypertension (PAH) market. The goal is to win market share by offering patients a simpler parenteral treatment for PAH.
|SteadyMed CEO Jonathan Rigby|
United Therapeutics' Remodulin currently rules the roost in PAH infusions, but the market is set to become a lot more congested. SteadyMed--which was spawned in Israel's RAD BioMed incubator in 2005--wants to offer patients the option to deliver Remodulin through a single-use pump. Additionally, Sandoz and Teva ($TEVA) are both aiming to have a generic competitor on the market by 2017. United Therapeutics is fighting back with its own plans to deliver Remodulin through a semidisposable pump and implant.
With the $490 million currently generated by United Therapeutics' Remodulin about to be up for grabs, SteadyMed is hoping U.S. investors will finance its attempts to claim a piece of the market. The drug-device combination specialist--which runs its R&D out of Rehovot, Israel--plans to use the cash to develop and commercialize Trevyent, its pump-based version of Remodulin. SteadyMed is aiming to file an NDA in the first quarter of 2016, and a European submission is scheduled for the first half of 2016.
The timeline puts SteadyMed on a collision course with generics from Sandoz and Teva, as well as United Therapeutics' semidisposable, subcutaneously delivered version of the drug. United Therapeutics is aiming to bring the product to market between 2016 and 2018, by which time it may already have four approved formulations of Remodulin. A Medtronic-developed Remodulin implant is currently being considered by FDA and United Therapeutics already has oral, injected and inhaled versions.