Benzinga | Oct 26, 2021 08:37AM EDT

Acer Therapeutics, Relief Therapeutics Announce Issuance Of U.S. Patent 11,154,521 Covering ACER-001 Formulation

Acer Therapeutics Inc. (NASDAQ:ACER) ("Acer") and its collaboration partner, RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF) ("Relief"), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new U.S. patent to Acer for certain claims related to ACER-001 (sodium phenylbutyrate). Patent 11,154,521 covers pharmaceutical composition claims related to ACER-001's taste-masked, multi-particulate dosage formulation for oral administration. The newly issued patent has an expiration date in 2036.



"We are extremely pleased that our ACER-001 formulation patent has been issued, adding key protection to our growing intellectual property portfolio for ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications," said Jeff Davis, Chief Business Officer at Acer. "This patent issuance is an important step in our pursuit of possible ACER-001 commercialization, and we intend to submit it for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, should ACER-001 receive marketing approval."

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, "In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022."

Parties interested in the ACER-001 program for UCDs may sign up for updates at:

https://www.acertx.com/rare-disease-research/acer-001-for-urea-cycle-disorders-ucds/

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.