Relief Therapeutics Provides Update From Collaboration Partner on OLPRUVA™ 

Relief Therapeutics Holding SA / Key word(s): Market Launch

15-March-2023 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

 Relief Therapeutics Provides Update From Collaboration Partner on OLPRUVA™ 

Acer Therapeutics reports OLPRUVA™ preliminary launch activities progressing; building out commercial and medical affairs teams to support U.S. launch in Q2 2023, with drug availability anticipated by early July 2023

Acer also announces results from a survey designed to quantify treatment preferences of healthcare providers for urea cycle disorders (UCDs) will be presented at SIMD 2023
 

GENEVA – March 15, 2023 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief Therapeutics"), a biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with rare diseases, today announces that its collaboration partner, ACER Therapeutics, Inc. (“Acer” or the “Company”), has provided an update on commercial launch activities for OLPRUVA™.  Relief Therapeutics entered a collaboration and license agreement with Acer Therapeutics Inc. in March 2021 for the worldwide development and commercialization of OLPRUVA™ (sodium phenylbutyrate; ACER-001) for oral suspension for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and maple syrup urine disease (MSUD).

Acer reports that in support of the OLPRUVA™ launch in Q2 2023, the Company is actively adding resources to establish its commercial and medical affairs presence in the U.S. As a part of its OLPRUVA™ commercialization strategy, Acer has recently introduced its patient support service, OLPRUVA™ Navigator by Acer Therapeutics, designed to assist UCD patients with support, access, education and patient adherence to treatment. Representatives will begin accepting prescriptions in late Q2 2023. Acer also reports the Company is actively engaged in negotiations regarding access for OLPRUVA™ with the major commercial payers and state Medicaid organizations.

According to Acer, the Company has established a pricing strategy that reflects its commitment to deliver innovative treatments that are responsibly priced and accessible to those in need. Acer intends to price OLPRUVA™ competitively, at a significant discount to the currently available commercial product RAVICTI^®, while implementing predictable pricing that will not increase beyond the rate of inflation. Acer indicated the Company also plans to invest a portion of OLPRUVA™ revenue back into additional solutions aimed at improving outcomes for UCD patients.

“We are pleased with the significant progress Acer has made toward the commercial launch of OLPRUVA™ and excited this new treatment option will soon be available to people living with UCDs,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “OLPRUVA is an innovative formulation of sodium phenylbutyrate packaged for the first time in single-dose envelopes, which can help patients, caregivers and their healthcare teams manage UCDs.”

UCD Survey Data Presentation at SIMD 2023

Acer will present data from a survey designed to quantify preferences of healthcare providers for urea cycle disorders (UCDs) at the upcoming 44^th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD), March 18–21 in Salt Lake City. Results from the discrete choice experiment will be available on Acer’s website on Sun., March 19 following the poster presentation by Professor Robert Steiner, M.D., University of Wisconsin School of Medicine and Public Health.  

Poster #97: Quantifying Preferences for Urea Cycle Disorder Treatments Using a Discrete-Choice Experiment

This poster summarizes results from a web-based, quantitative survey study using a discrete choice experiment (DCE) methodology. This study sought to capture the perspectives of healthcare providers (HCPs) with experience treating UCDs to quantify the attributes of nitrogen-binding medications (such as sodium phenylbutyrate and glycerol phenylbutyrate) for UCDs that may influence overall prescription and patient adherence.

Previously Presented ACER-001 (sodium phenylbutyrate) Palatability Data

Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders^1,2

Results from two Phase 1, open-label, repeated measures, taste assessment studies of ACER-001 (sodium phenylbutyrate) suspension and sodium phenylbutyrate (BUPHENYL^®) powder were previously presented at the 43^rd SIMD Annual Meeting in April 2022 and the Genetic Metabolic Dieticians International (GMDI) Conference in May 2022. Results from both studies concluded that ACER-001 (sodium phenylbutyrate) suspension was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL^®) powder when administered within five minutes of preparation.

ABOUT UREA CYCLE DISORDERS

Urea cycle disorders (UCDs) are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood. Any increase in ammonia over time is serious. Long-term toxic ammonia levels can lead to liver and brain damage, severe ketoacidosis, and can even be fatal when left untreated.³ Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels. Non-compliance with current therapies is a major issue due to unpleasant taste and odor and cost of treatment.

ABOUT OLPRUVA™ (SODIUM PHENYLBUTYRATE, ACER-001) FOR ORAL SUSPENSION

On Dec. 22, 2022, the U.S. Food and Drug Administration (FDA) approved OLPRUVA™ (sodium phenylbutyrate, ACER-001) for oral suspension as a prescription medicine for use with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).⁴ Please see Important Safety Information and full Prescribing Information, including Patient Information.

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 rare diseases. Since founding in 2013, Relief Therapeutics continues to build a diversified pipeline of risk-mitigated assets to address metabolic, dermatology/connective tissue disorders as well as pulmonary and genetic diseases. Our portfolio also includes a balanced mix of marketed, revenue-generating products and the proprietary, globally patented Physiomimic™ and Tehclo^® platform technologies which were obtained through the acquisition of APR Applied Pharma Research S.A. in June 2021. Our mission is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics’ headquarters are located in Geneva, with additional offices in Balerna, Switzerland, Rome, Italy and Offenbach am Main, Germany. The Company 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 communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its businesses.  Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks described in RELIEF THERAPEUTICS Holding SA’s press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission, all of 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 does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

REFERENCES

1. Steiner R, et al. The Pharmacokinetics of Taste-Masked Sodium Phenylbutyrate (ACER-001) for the Treatment of Urea Cycle Disorders Under Fasting and Fed Conditions in Healthy Volunteers. SIMD April 2022
2. Cederbaum S, et al. Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders. GMDI May 2022
3. Ah Mew N, et al. Urea cycle disorders overview [updated June 22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews^® [Internet]. University of Washington; 1993-2022. Accessed March 20, 2022.
4. OLPRUVA^TM (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc.