Relief Therapeutics' Wholly Owned Subsidiary, APR Applied Pharma Research, Receives Notice of Allowance of Key U.S. Patent Application Covering PKU GOLIKE(R)

Relief Therapeutics Holding SA / Key word(s): Patent

27-Apr-2022 / 07:00 CET/CEST
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Relief Therapeutics' Wholly Owned Subsidiary, APR Applied Pharma Research, Receives Notice of Allowance of Key U.S. Patent Application Covering PKU GOLIKE(R)

Notice of Allowance of Patent Application for Modified Release Orally Administered Amino Acid Formulations, Strengthens Proprietary Position in U.S. until 2036

Geneva, Switzerland, April 27, 2022 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), has received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for Patent Application No. 15/303,121 entitled, "Modified Release Orally Administered Amino Acid Formulations."

The allowed claims cover certain PKU GOLIKE(R) formulations in APR's product line, intended to enhance the dietary management of patients living with phenylketonuria (PKU). The PKU GOLIKE(R) family of products are a phenylalanine-free food for special medical purposes (FSMP), comprising amino acid granules engineered with APR's Physiomimic Technology(TM), a modified-release amino acid technology that ensures a prolonged physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The patent resulting from this application will have an expiration date of no earlier than September 27, 2036. When issued, the patent will supplement APR's PKU GOLIKE(R) intellectual property portfolio, which currently includes U.S. Patent No. 10,500,180, which also expires no earlier than September 27, 2036.

"The receipt of this Notice of Allowance from the USPTO for PKU GOLIKE(R), powered by our proprietary, Physiomimic(TM) Technology, is another important milestone that helps strengthen our intellectual property position, which we will continue to build upon going forward. As we focus on increasing sales in the U.K. and Europe, we will continue our efforts in preparing for a potential U.S. launch," stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. "The novel formulation of each product within the PKU GOLIKE(R) family has proven to allow for the absorption of amino acids more closely resembling the natural protein in healthy humans, providing a distinct advantage for the treatment of patients suffering from PKU. As part of our commitment to expanding access to this important product, we are actively building out a U.S. commercial infrastructure, with the aim of launching PKU GOLIKE(R) as a treatment to PKU patients in the U.S. sometime in the second half of this year, assuming the product is approved for commercialization in the United States."

About PKU GOLIKE(R)
The PKU GOLIKE(R) family of products are phenylalanine-free food for special medical purposes (FSMP) or medical formulas in the U.S. The products comprise a mixture of amino acids formulated in granules. Engineered with the Company's patented Physiomimic(TM) Technology platform, PKU GOLIKE(R) is the first prolonged-release amino acid product, characterized by a special coating that ensures a more physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.

About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of phenylalanine free-amino acid-mix to prevent protein deficiency and optimize metabolic control.

ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's drug candidate, RLF-100(R) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief's collaboration partner in the U.S., NeuroRx, Inc. Relief also has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001, a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Acer's new drug application for ACER-001 for use as a treatment of urea cycle disorders was recently accepted by the FDA for filing with a PDUFA decision date of June 5, 2022. Finally, Relief's acquisitions last summer of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.

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 symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

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