SteadyMed to be acquired by United Therapeutics for up to $216 million

SteadyMed entered into a definitive merger agreement to be bought out by United Therapeutics for as much as $216 million, the companies announced Monday. Under the deal, United will pay $4.46 per share in cash at closing and an additional $2.63 per share in cash upon the achievement of a milestone related to the commercialisation of SteadyMed's investigational drug-device combination product Trevyent for the subcutaneous treatment of pulmonary arterial hypertension (PAH). Shares in SteadyMed jumped as much as nearly 76 percent on the news. 

According to the companies, Trevyent combines SteadyMed's disposable PatchPump technology with the vasodilatory prostacyclin analogue treprostinil as a subcutaneous treatment for PAH. The proposed merger, which is expected to close in the third quarter, has been unanimously approved by SteadyMed's board of directors, while shareholders controlling about 43.3 percent of ordinary shares in the company have agreed to support the transaction.

In August last year, SteadyMed received a refuse-to-file letter from the FDA relating to its submission for Trevyent as a potential treatment for PAH. At the time, the agency had requested more information about certain device specifications and performance testing, as well as additional design verification and validation testing on the final Trevyent product. In December, SteadyMed said the US regulator agreed to a pathway for its Trevyent resubmission that did not require the company to conduct any further clinical trials.

Cardiome, which licensed the commercial rights to Trevyent in Europe, Canada and the Middle East, has said it plans to file regulatory submissions for Trevyent in Europe and Canada following SteadyMed's resubmitted US filing in 2018.