Shares of SteadyMed Ltd. have skyrocketed more than 77 percent in premarket trading today after United Therapeutics announced it will acquire the company for a total of $216 million, including $75 million in contingent consideration.
Shares of SteadyMed Ltd. have skyrocketed more than 77 percent in premarket trading today after United Therapeutics announced it will acquire the company for a total of $216 million, including $75 million in contingent consideration.
California-based SteadyMed is a specialty pharmaceutical company focused on the development and commercialization of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs. For Silver Spring, Maryland-based United Therapeutics the acquisition serves a twofold purpose. For one, the deal centers on SteadyMed’s experimental combination therapy Trevyent for the subcutaneous treatment of pulmonary arterial hypertension (PAH). Trevyent combines SteadyMed’s two day, single-use, disposable PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue. The addition of Trevyent will complement United Therapeutics existing platform for the treatment of PAH. The company currently markets four therapies for pulmonary arterial hypertension, including Tyvaso, which was approved by the U.S. Food and Drug Administration in 2009.
The other primary point of the deal is to likely end patent disputes between the two companies. Last year the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office ruled in favor of SteadyMed’s Inter Partes Review over an ingredient process used in the development of PAH drugs by both companies. That ruling allowed SteadyMed to move forward in seeking approval of Trevyent. After an initial rejection by the FDA last year, Trevyent is now awaiting approval from the regulatory agency. SteadyMed successfully resubmitted its New Drug Application to the Food and Drug Administration (FDA) in December without the need to conduct any additional trials. Following meetings with the FDA SteadyMed did agree to a repeat of in vitro Design Verification (DV) testing on the final to-be-marketed Trevyent product. The purpose of in vitro DV testing is to confirm that Trevyent performance meets its design specifications, the company said in December.
Martine Rothblatt, chairman and chief executive officer of United Therapeutics, said the company is optimistic about the SteadyMed deal and adding Trevyent to its pipeline.
“Trevyent fits in well with our mission, and we look forward to bringing the product to the maximum number of patients as soon as possible,” Rothblatt said in a statement.
Jonathan Rigby, SteadyMed’s CEO, touted the deal saying he believes the acquisition will help his company realize its “commitment to bring Trevyent to market to improve the lives of patients with PAH.”
The deal for SteadyMed is a turnaround for United Therapeutics, which less than a year ago was considered a target of acquisition itself. Last year multiple companies, including GlaxoSmithKline and Gilead Sciences, were rumored to be circling United Therapeutics.
