Relief Therapeutics Recognizes Rare Disease Day and Announces U.S. Availability of New PKU GOLIKE Bars

Relief Therapeutics Recognizes Rare Disease Day and Announces U.S. Availability of New PKU GOLIKE^® Bars

Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR Applied Pharma Research SA, shares his family’s rare story of living with phenylketonuria

GENEVA, FEB. 28, 2023 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with specialty and rare diseases, is pleased to recognize Rare Disease Day 2023 and announce the U.S. availability of the new PKU GOLIKE™ bars, a medical food for the dietary management of phenylketonuria (PKU).

“For me, it’s not just a job – it’s personal. My oldest son Riccardo was born with PKU, a rare, lifelong metabolic disease I had never heard of before his birth. I learned that living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. The diagnosis was overwhelming and terrifying at first,” said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR Applied Pharma Research SA. “My son Riccardo inspires me in my work every day. We are proud to introduce the new tropical and red fruit flavored PKU GOLIKE bars today, which were developed by patients and for patients.”

People living with PKU do not have the ability to metabolize the amino acid phenylalanine (Phe) found in many foods and they require supplementation of amino acid-based foods for special medical purposes (FSMPs) to prevent protein deficiency and optimize metabolic control. Currently available FSMPs lead to poor or suboptimal clinical outcomes and compliance because they are rapidly absorbed and are characterized by an unpleasant odor and aftertaste. Such factors contribute to barriers to social interaction for PKU patients, further limiting FSMP compliance and exposing patients to the risks of poor disease control.

“Everyone in the Relief family works hard every day to make a difference in the lives of all patients and families managing rare diseases around the world. We are very grateful to Paolo for sharing his personal story and share his strong commitment to families dealing with PKU,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “Our teams have spent the past four years conducting focus groups and qualitative research, working directly with patients, caregivers and healthcare providers to develop the new PKU GOLIKE bars, which really address the needs expressed by patients. We’re happy to celebrate this Rare Disease Day by offering a new, unique product on the market.”

The new PKU GOLIKE Bars were developed with Physiomimic™ technology, the Company’s next-generation, prolonged-release amino acid mix, and contain real fruit in tropical and red fruit flavors, from natural ingredients. More flavors of the bars and other forms of PKU GOLIKE are currently in development. The new grab-and-go bars are ready to use and easy to carry. The 5 g protein equivalent per bars have less than 8 mg of Phe per bar and come 20 bars in each box and the 10 g protein equivalent per bars have less than 15 mg of Phe per bar and come with 10 bars in each box.

To learn more about Paolo and Riccardo’s story, please visit: https://www.youtube.com/watch?v=9JvKcv6J_go

ABOUT PHENYLKETONURIA (PKU)

Phenylketonuria (PKU) is a rare inherited disorder affecting more than 450,000 patients worldwide.^[1] PKU is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of phenylalanine from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures.[2] To avoid these serious consequences, people with PKU must comply with a strict diet that limits intake of phenylalanine from infancy onward. Patients with PKU require supplementation of amino acids formulated as foods for special medical purposes (FSMP) to prevent protein deficiency.

ABOUT PKU GOLIKE^®

PKU GOLIKE^® is a phenylalanine-free food intended for special medical purposes (FSMP) for both children and adults. PKU GOLIKE is comprised of a mixture of amino acids in the form of granules and available in convenient packets and medical food bars. Developed with the company's proprietary, patent-protected Physiomimic™ technology platform, PKU GOLIKE^® products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor and aftertaste of the amino acids. PKU GOLIKE^® granules are flavorless and can be mixed with many of your favorite foods. PKU GOLIKE^® contains all 19 amino acids that people with PKU need to maintain neurological and muscular health and is fortified with 27 essential vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium, and vitamin B12. PKU GOLIKE^® products have been commercially available in Europe since 2019 and in the U.S. since October 2022.

For more information in the U.S., please visit https://www.pkugolike.com/. Please note this site is intended for U.S. audiences only.

For more information in Europe, please visit: https://www.apr.ch/apr-pharma-products/medical-prescription/pku-golike-family/

ABOUT APR APPLIED PHARMA RESEARCH SA

APR Applied Pharma Research SA is a wholly owned subsidiary of Relief Therapeutics acquired in June 2021.

ABOUT RELIEF THERAPEUTICS

Relief Therapeutics is a Swiss, commercial-stage, biopharmaceutical company focused on the development and commercialization of products in select specialty and rare diseases, including metabolic disorders, pulmonary diseases and connective tissue disorders. Relief Therapeutics’ diversified pipeline consists of assets with the potential to effectively address significant unmet medical needs. PKU GOLIKE^®, developed with our proprietary Physiomimic™ technology, is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (PKU). Relief Therapeutics has a collaboration and license agreement with Acer Therapeutics for the worldwide development and commercialization of Olpruva™ (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). Relief Therapeutics continues to develop RLF-100 (aviptadil) for several pulmonary indications. Further, Relief Therapeutics is undertaking the clinical development of RLF-TD011 for the treatment of epidermolysis bullosa, an indication for which the FDA has granted Orphan Drug designation. Relief Therapeutics is also exploring the clinical development of RLF-TD011 for the treatment of cutaneous t-cell lymphomas. Finally, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners.

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, please visit www.relieftherapeutics.com or follow Relief Therapeutics on LinkedIn and Twitter.
 

DISCLAIMER

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the commercialization of PKU GOLIKE^® in the United States will be successful, and (ii) those factors described in Relief's reports to the SIX Swiss Exchange and the Securities and Exchange Commission could adversely affect Relief, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov.

^[1] Hillert A, Anikster Y, Belanger-Quintana A, et al. The Genetic Landscape and Epidemiology of Phenylketonuria. Am J Hum Genet. 2020;107(2):234-250. doi:10.1016/j.ajhg.2020.06.006

^[2] Blau N, van Spronsen FJ, Levy HL. Phenylketonuria. Lancet. 2010 Oct 23;376(9750):1417-27. doi: 10.1016/S0140-6736(10)60961-0. PMID: 20971365.