United Therapeutics has struck a $216 million deal to buy SteadyMed. The acquisition enables United to eliminate a potential threat by taking control of a startup that has been fighting to invalidate its patents and mount a pump-based attack on its pulmonary arterial hypertension (PAH) franchise.
SteadyMed’s pitch for the PAH market is Trevyent, a therapy that delivers the active ingredient in United’s Remodulin through a single-use pump. The idea was to steal the PAH sector out from under United—and expand the market addressable by Remodulin—by making it far easier for patients and caregivers to administer the drug on the go.
SteadyMed has spent the past few years working to win approval for Trevyent and clear away the United patent that could throttle its business. But SteadyMed’s progress has stuttered, positioning United to buy its rival at a knockdown price.
The FDA delivered the telling blow to SteadyMed in August when it issued a refusal-to-file notice to a submission for approval of Trevyent. The refusal picked holes in the device side of SteadyMed’s filing, tasking the firm with providing more information on device specifications and performance testing. Regulatory officials also asked for additional design verification and validation testing.
SteadyMed has spent the past eight months working through the issues, bringing it to the point that it set an end-of-2018 target for its Trevyent resubmission. That would establish SteadyMed as a possible threat to United again. And, with SteadyMed trading for a fraction of its former share price, United has decided it makes sense to eliminate the risk and claim the opportunity for itself.
“We are optimistic about acquiring SteadyMed and adding Trevyent to our pipeline of products to treat PAH,” United CEO Martine Rothblatt, Ph.D., said in a statement. “We are especially impressed with SteadyMed’s management team and global supply chain.”
SteadyMed was part of a wave of Israeli biotechs that listed on Nasdaq in the heady time around of 2015, albeit at at a lower-than-hoped price, only to struggle as public companies. Shares in the PAH player never got close to the $10 mark they flirted with in 2015. Perceptions of SteadyMed’s prospects brightened for four months last year after it wrapped up a Trevyent study and chalked up a legal win against United. But the FDA refusal-to-file letter brought the party to a close.