Relief Therapeutics and World Orphan Drug Alliance Announce an Exclusive, Long-Term, Distribution Agreement to Introduce PKU GOLIKE® in the Middle East – Biotech Investments

Ad hoc announcement pursuant to Art. 53 LR

Relief Therapeutics and World Orphan Drug Alliance Announce an Exclusive, Long-Term, Distribution Agreement to Introduce PKU GOLIKE^® in the Middle East
 

GENEVA and DUBAI, United Arab Emirates (June 23, 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, and the World Orphan Drug Alliance (WODA Alliance, or WODA), a global alliance of full-service regional distributors specializing in the commercialization of orphan drugs, today announced an exclusive, long-term distribution agreement (the Definitive Agreement) between Relief Therapeutics’ subsidiary APR Applied Pharma Research SA and WODA’s member company Vector Pharma FZCO (Vector Pharma) to introduce PKU GOLIKE Plus^® 3-16 in the Middle East.

“This agreement speaks to the global need for optimized treatment options to help patients living with phenylketonuria (PKU) effectively manage their condition. As the first controlled-release, taste- and odor-masked food for special medical purposes (FSMPs), PKU GOLIKE^® offers the potential for better metabolic management and improved compliance for patients who must contend with the lifelong dietary restrictions associated with PKU,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “This also marks a significant milestone in our global expansion strategy. The WODA members are well-established organizations with the ability to provide local market knowledge, expertise and broad outreach. We are pleased to be working with WODA to introduce PKU GOLIKE Plus^® 3-16 in the Middle East.”

Under the terms of the Definitive Agreement, WODA will receive the exclusive rights to distribute PKU GOLIKE Plus^® 3-16 in the following Middle Eastern countries: Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman, Libya and Iraq. WODA will be responsible for securing regulatory approvals and local reimbursements, where required. WODA, with support from Relief Therapeutics, will also be responsible for the local market launch, marketing and promotion of PKU GOLIKE Plus^® 3-16. In addition, Relief Therapeutics and WODA are engaged in continuing discussions regarding the possibility to extend their collaboration to additional territories and other PKU GOLIKE^® products.

“We are excited to begin this partnership with Relief Therapeutics and become the distributor of choice for such a novel product, like PKU GOLIKE Plus^® 3-16, in the selected Middle Eastern territories, where there is a high prevalence of PKU in certain populations^[1],” said Patrick Jordan, chairman of the World Orphan Drug Alliance. “Our agreement with Relief Therapeutics is yet another positive example of how we are collaborating with our industry partners to ensure that communities across the globe have access to the best and most innovative healthcare products possible. Our multi-territorial platform provides an alternative for biotech companies seeking a one-stop solution to facilitate commercialization of their products in countries where they do not have local market resources.”

PKU GOLIKE Plus^® 3-16 is an FSMP in granules for oral use, consisting of a prolonged-released amino acid mixture without phenylalanine (Phe) for the dietary management of PKU in children between 3 and 16 years of age. PKU GOLIKE Plus® 3-16 contains vitamins, minerals and other nutrients and is gluten and lactose free.

Phenylketonuria (PKU) is a rare inherited disorder affecting approximately 450,000 patients worldwide.^[2] 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.^[3] Treatment of PKU is lifelong to avoid these serious consequences and people living with PKU must follow a strict diet that limits intake of Phe from infancy onward. People living with PKU require supplementation of amino acids formulated as foods for special medical purposes (FSMP) to prevent protein deficiency.

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 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.^[4]

ABOUT PKU GOLIKE^®

PKU GOLIKE^® products are phenylalanine-free foods for special medical purposes (FSMPs) for 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+), medical food bars (PKU GOLIKE BAR^®) and tablets to be chewed (PKU GOLIKE KRUNCH^®). PKU GOLIKE^® products have been commercially available in Europe since 2018 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/.

The World Orphan Drug Alliance (WODA) is a global alliance of commercial distributors focused on providing access to treatments for rare diseases and specialty medicines in complex and underserved markets around the world. WODA aims to provide comprehensive support to pharmaceutical and biotech companies with rare disease, oncology and highly specialized therapeutics portfolios, starting from named patient programs through full commercialization. More about WODA: www.woda-alliance.com.

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.

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
^[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] IBID
^[3] 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.
^[4] Ford, 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.