Brief:

• United Therapeutics announced Monday morning that it will acquire competitor SteadyMed for $4.46 per share in cash upfront and another $2.63 per share in cash via milestone payments related to the commercialization of Trevyent. The total deal is valued at $216 million.
• Trevyent, a treatment for pulmonary arterial hypertension (PAH), was submitted for approval with the Food and Drug Administration in 2017. The agency issued a Refusal to File letter, choosing not to review the application until the company provided additional information about testing procedures for the product.
• The SteadyMed board of directors has unanimously approved the transaction and 43% of shareholders have already committed their shares in favor of the deal, which is expected to close in the third quarter.

Insight:

Despite a setback last summer for Trevyent, a drug-device combo of treprostinil, United Therapeutics could see the approval writing on the wall and chose to pick up the company first rather than compete on the marketplace later.

SteadyMed announced in December that it had met with the FDA regarding the Refusal to File letter and that the agency would not require further clinical trials for the drug to move forward for approval. The California biotech said at the time that it expects to resubmit its application before the end of 2018.

The smaller biotech has been a thorn in the side of United Therapeutics for a number of years now. Trevyent is essentially a patch-pump version of the bigger company’s injectable PAH drug Remodulin. United Therapeutics also makes an inhalable version that is marketed as Tyvaso, and an extended-release tablet that is marketed as Orenitram.

Remodulin alone fetched $670.9 million for the company in 2017, representing almost 40% of United Therapeutics’ total revenues. Meanwhile, Tyvaso brought in $372.9 million, or about 22% of the company’s total sales. Orenitram snagged another $185.8 million last year, representing 11% of revenues. All told, the PAH family of products makes up more than 70% of United Therapeutics’ sales.

“We are optimistic about acquiring SteadyMed and adding Trevyent to our pipeline of products to treat PAH,” Martine Rothblatt, CEO of United Therapeutics, said in a statement.

SteadyMed stock jumped on the news of the takeout, adding 77% in early morning trading to trade above the upfront value of $4.70 per share.