EQS Group-Ad-hoc: RELIEF THERAPEUTICS Holding AG / Key word(s): Miscellaneous Acer Therapeutics and Relief Therapeutics Announce Issuance of U.S. Patent 11,154,521 Covering ACER-001 Formulation Key ACER-001 formulation composition of matter patent strengthens proprietary position in U.S. until 2036 NEWTON, MA and GENEVA, SWITZERLAND - October 26, 2021 - 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: 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. About UCDs Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI(R) and BUPHENYL(R), in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3 About ACER-001 About Acer Therapeutics Inc. About RELIEF THERAPEUTICS Holding SA RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn. 1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993. 2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32). 3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47. Acer Forward-Looking Statements Relief Forward-Looking Statements
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Language: | English |
Company: | RELIEF THERAPEUTICS Holding AG |
Avenue de Sécheron 15 | |
1202 Genève | |
Switzerland | |
E-mail: | contact@relieftherapeutics.com |
Internet: | https://relieftherapeutics.com |
ISIN: | CH0100191136 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 1243361 |
End of Announcement | EQS Group News Service |
1243361 26-Oct-2021 CET/CEST