Relief Therapeutics Announces Extension of Distribution Agreement for PKU GOLIKE® in the U.S. with Pentec Health

Relief Therapeutics Announces Extension of Distribution Agreement for PKU GOLIKE^® in the U.S. with Pentec Health

Recent Pentech Health acquisition of ZOIA Pharma broadens distribution and access for patients to PKU GOLIKE^®

GENEVA (July 19, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief Therapeutics, or the Company), a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, today announced an extension of its exclusive, long-term agreement with Pentec Health, Inc. (Pentec Health), broadening the distribution of PKU GOLIKE^® in the U.S. Pentec Health is a leading provider of healthcare services for complex care challenges, including clinical nutrition and specialty care, and the exclusive distributor of PKU GOLIKE^® in the U.S.

“Following the announcement of Pentec Health’s acquisition of ZOIA Pharma, we are excited to expand and deepen our partnership with Pentec Health to continue to provide our innovative PKU GOLIKE^® family of products to the PKU community,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “As the first prolonged-release, taste- and odor-masked medical food, PKU GOLIKE^® offers the potential for better metabolic management and improved compliance for patients who must contend with the lifelong dietary restrictions associated with this debilitating and rare condition.”

The acquisition of ZOIA Pharma by Pentec Health provides patients living with PKU who purchase  products through ZOIA Pharma access to PKU GOLIKE^®. This enables Relief Therapeutics to broaden distribution of PKU GOLIKE^® across an expanded commercial payor base, ensuring more patients living with PKU will have access to the PKU GOLIKE^® family of products to help them manage their condition.

“Working together, Pentec Health, ZOIA Pharma and Relief Therapeutics are helping to solve problems in the rare disease world to improve the health of people with these conditions,” said Matthew Deans, president and chief executive officer of Pentec Health. “We are an extension of the family’s care team and the combination of ZOIA’s expertise in medical foods and Pentec’s ability to support expanded coverage across Medicaid, increases availability, which is vital for patient access and adherence.”

According to the National PKU Alliance, there are approximately 16,500 people living with phenylketonuria (PKU) in the U.S. People living with PKU do not have the ability to metabolize phenylalanine (Phe), which is found in many foods, and therefore require supplementation of amino acid-based medical foods to prevent protein deficiency and optimize metabolic control.

“The combined forces of Pentec Health and Zoia Pharma is one of the most consequential developments in the past decade for the distribution of medical foods,” said Chris Wick, U.S. country lead of Relief Therapeutics. “The expanded reach and capabilities will enable us to serve more patients in the PKU community with PKU GOLIKE^® for years to come.”

ABOUT PHENYLKETONURIA (PKU)
Phenylketonuria (PKU) is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe 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.¹ Living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. People living with PKU do not have the ability to metabolize Phe, which is 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 may 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.²

ABOUT PKU GOLIKE^®
PKU GOLIKE^® products are foods for special medical purposes (FSMPs) for the dietary management of PKU in both children and adults. Developed with the Relief Therapeutics proprietary, patent-protected Physiomimic Technology™ drug delivery 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 foods. PKU GOLIKE^® products contain 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. The PKU GOLIKE^® line of products are available in convenient packets (PKU GOLIKE Plus^® 3-16 and 16+) and medical food bars (PKU GOLIKE BAR^®). PKU GOLIKE^® products have been commercially available in the U.S. since October 2022. For more information, please visit https://www.pkugolike.com/ (Please note this site is intended for U.S. audiences only).

ABOUT PENTEC HEALTH INC.
Pentec Health Inc. is committed to solving and simplifying complex care challenges to better meet patient and provider needs. Pentec’s unique solutions, based on empathy, technical expertise, and clinical collaboration, deliver exceptional results through proven delivery models that reduce administrative burdens and improve outcomes through trusted, long-term relationships. Pentec Health serves more than 11,000 patients living with complex medical conditions, with care provided across the nation by more than 350 clinicians. To learn more, visit http://www.pentechealth.com

ABOUT RELIEF THERAPEUTICS
Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief Therapeutics' portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ drug delivery platform technologies and a highly targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners. Relief Therapeutics' mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief Therapeutics 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 our website 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, uncertainties, and other factors, which could cause the actual results, financial condition, performance, or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Several factors, including those described in Relief Therapeutics' filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief Therapeutics. Copies of Relief Therapeutics' filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date.

REFERENCES
¹Blau 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.
²Ford, Suzanne et al. “Living with Phenylketonuria: Lessons from the PKU community.” Molecular genetics and metabolism reports. Vol. 17 57-63. 18 Oct. 2018, doi:10.1016/j.ymgmr.2018.10.002.