Acer Therapeutics and Relief Therapeutics Announce That the China National Intellectual Property Administration (CNIPA) Issued Utility Model Patent 11,202,767 Covering ACER-001 Dosage Form

NEWTON, Mass. and GENEVA, July 08, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (NASDAQ:ACER ) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF , RLFTY)) (Relief), today announced that the China National Intellectual Property Administration (CNIPA) issued Electronic Patent Certificate ZL202122004991.9 on May 24, 2022, for Utility Model directed to ACER-001 (sodium phenylbutyrate). Specifically, the newly issued patent covers dosage form claims related to ACER-001's polymer coated formulation for oral administration as a potential treatment for urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD). The newly issued patent has an expiration date of August 24, 2031. "The receipt of this patent from the CNIPA for ACER-001, is an important milestone for Acer and Relief, adding key protection to the growing intellectual portfolio of this coated formulation of sodium phenylbutyrate, which could be an important treatment for patients with UCDs and we hope to extend its use as a potential treatment for MSUD and other indications," stated Raghuram (Ram) Selvaraju, Chairman of Relief. "The issuance of this patent also marks an important step in our pursuit of possible ACER-001 commercialization in China." About ACER-001 ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001 is a polymer coated formulation that, when taken within 5 minutes, helps prevent the coating from dissolving. ACER-001 has been granted orphan drug designation by the FDA for MSUD. 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 Acer will be able to meet its intended resubmission timeline for the NDA, that FDA inspection of the third-party contract packaging manufacturer facility will be satisfactory, that such inspection is the only impediment to FDA approval of a resubmitted NDA, that a resubmitted NDA will otherwise be approved by the FDA, or that ACER-001 will be approved for any indication. About Acer Therapeutics Inc. Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer's pipeline includes four investigational programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms ... Full story available on Benzinga.com
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