SAN RAMON, Calif., Nov. 14, 2017 (GLOBE NEWSWIRE) — SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that the United States Court of Appeals for the Federal Circuit affirmed a March 31, 2017, ruling by the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO), invalidating U.S. Patent No. 8,497,393 (the ‘393 patent) owned by United Therapeutics (Nasdaq:UTHR).
The case, United Therapeutics Corporation v. SteadyMed Ltd. (Appeal No. 17-2121) was filed by United Therapeutics on June 1, 2017, and sought to reverse the earlier decision by the PTAB, which found that all 22 claims in the ‘393 patent were invalid, and therefore, cancelled them. The ‘393 patent claimed a prostacyclin-derivative product, treprostinil, or treprostinil salts, made by a particular process. Treprostinil is the active pharmaceutical ingredient used in United Therapeutics’ Remodulin® and SteadyMed’s lead drug candidate, Trevyent®, which is in development for the treatment of Pulmonary Arterial Hypertension (PAH).
The invalidity decision will preclude United Therapeutics from asserting the ‘393 patent prior to SteadyMed’s launch of its Trevyent product. Moreover, because the ‘393 patent has now been invalidated by the appeals court, FDA regulations require that United Therapeutics “promptly notify FDA to…withdraw the patent” from the FDA’s “Orange Book.” Once a patent is removed from the Orange Book, neither 505(b)(2) NDA applicants such as SteadyMed, nor generic ANDA applicants for copies of Remodulin will be required to submit a patent certification to that patent in their applications.
“We are very pleased with the court’s decision to uphold the PTAB’s earlier ruling on the ‘393 patent,” said Jonathan M.N. Rigby, President & CEO of SteadyMed. “Once again, this reaffirms our assertion that the claims of the patent were invalid and unpatentable.”
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. SteadyMed’s investigational drug product candidate, Trevyent, is designed to address a number of unmet needs in the treatment of pulmonary arterial hypertension (PAH). Trevyent combines SteadyMed’s preservative-free, treprostinil formulation with its proprietary PatchPump®, which, if approved by the U.S. Food and Drug Administration (FDA), will offer PAH patients a sterile, pre-filled, pre-programmed, single-use, disposable infusion system for parenteral treprostinil administration.
SteadyMed intends to commercialize Trevyent in the U.S., and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East, pending regulatory approvals. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect the company’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the risk that Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that when the Trevyent NDA is resubmitted it is not accepted for filing by the FDA, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will continue to need additional funding, and that the company may be unable to raise capital when needed, which would force the company to delay, reduce or eliminate its product candidate development programs and potentially cease operations. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q filed on November 13, 2017. The company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof except as may be required by law.
Senior Director, Investor Relations and Marketing
The Ruth Group