United Therapeutics has agreed to acquire SteadyMed Therapeutics for up to $216 million, the companies said today, in a deal designed to absorb a potential competitor with which the would-be buyer has been embroiled in a legal wangle over a patent for its top-selling drug.

SteadyMed’s lead product candidate is the drug–device combination Trevyent (treprostinil sodium), a subcutaneous treatment for pulmonary arterial hypertension (PAH) that combines the company’s two-day, single-use, disposable PatchPump® technology with its formulation of treprostinil, a vasodilatory prostacyclin analog. SteadyMed has licensed Trevyent rights in Europe, Canada, and the Middle East to Cardiome.

United Therapeutics said Trevyent would complement its portfolio of marketed and pipeline products for orphan diseases. The top sellers among those offerings are four PAH-indicated treatments: the subcutaneous or intravenous pump therapy Remodulin® (treprostinil), which finished 2017 with $670.9 million in total revenues, up 11.4% from 2016; the inhalation drug Tyvaso® (treprostinil), which generated $372.9 million (down 7.8%); the oral drug Adcirca® (tadalafil), which racked up $419.7 million (up 12.8%); and Orenitram® (treprostinil) extended-release tablets, $185.8 million (up 18.2%).

The four PAH treatments accounted for nearly 96% or $1.649 billion of the $1.725 billion in total revenues reported by Silver Spring, MD-based United Therapeutics in 2017.

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

Added SteadyMed president and CEO Jonathan M.N. Rigby: “United Therapeutics has always been at the forefront of developing therapies to treat PAH, and we are delighted at the prospect of our companies coming together, as one, to continue that mission. We believe that this proposed acquisition will help us realize our commitment to bring Trevyent to market to improve the lives of patients with PAH.”

Headquartered in San Ramon, CA, SteadyMed finished last year with a net loss of $23.2 million, down from $25.9 million in 2016.

Planning NDA Resubmission

The acquisition announcement comes four months after SteadyMed said it resolved details with the FDA on work needed in order to resubmit a New Drug Application (NDA) for Trevyent before the end of this year. SteadyMed suffered a setback in August 2017 when the FDA issued a Refusal to File letter halting the Trevyent NDA, as well as the company’s plans to launch the drug in mid 2018. The agency concluded that the application was incomplete and required additional design verification and validation testing data.

Following a Type A meeting with the FDA that SteadyMed termed “positive and collaborative” in a December 8, 2017, statement, the company agreed to repeat its in vitro design verification (DV) testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modeling and process validation, with the goal of confirming that Trevyent performance meets its design specifications. SteadyMed said at the time that it had begun pre-design verification (pre-DV) activities, with Trevyent performance data to be available “around mid 2018.”

However, in November 2017, the U.S. Court of Appeals affirmed a March 2017 ruling by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office that invalidated U.S. Patent No. 8,497,393, owned by United Therapeutics. The patent related to a product made by a process intended to purify treprostinil—the active pharmaceutical ingredient used in both Remodulin and Trevyent—and other prostacyclin derivatives (United Therapeutics Corporation v. SteadyMed Ltd.). An appellate suit (Appeal No. 17-2121) was filed after the PTAB’s decision.

United Therapeutics agreed to acquire privately held SteadyMed for $141 million or $4.46 per share in cash at closing, and an additional $75 million or $2.63 per share in cash tied to achieving a commercialization milestone related to Trevyent.

The deal is expected to be completed in the third quarter subject to customary closing conditions, including approval by SteadyMed's shareholders and the expiration or termination of the required waiting period under the Hart–Scott–Rodino Antitrust Improvements Act,

SteadyMed’s board has unanimously approved the merger agreement and has unanimously recommended that SteadyMed shareholders adopt the merger agreement, the companies said. SteadyMed shareholders owning approximately 43.3% of the company’s ordinary shares have agreed to vote their shares in favor of the transaction.

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