Relief Therapeutics Announces Collaboration Partner Reports OLPRUVA™ Commercial Launch Progressing Ahead of Schedule

Relief Therapeutics Announces Collaboration Partner Reports OLPRUVA™ Commercial Launch Progressing Ahead of Schedule 

Acer reports OLPRUVA™ drug availability anticipated in mid-June 2023; Acer is engaged in discussions with payers representing a substantial majority of covered lives; 70 percent of metabolic treatment providers surveyed by Acer at SIMD Annual Meeting indicated an interest in treating at least one of their patients with OLPRUVA™ in 2023

GENEVA (May 1, 2023) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief Therapeutics), 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, announced today that its collaboration partner, ACER Therapeutics, Inc. (Acer), has provided an update indicating that the commercial launch activities for OLPRUVA™ (sodium phenylbutyrate) for oral suspension are progressing ahead of schedule. Acer now reports the drug will be available in mid-June 2023, subject to additional capital.

As a result of ongoing launch readiness efforts, Acer has reported it expects select OLPRUVA™ dose levels to be available to patients beginning in mid-June 2023 at which time representatives from Acer’s patient support service will be available to begin accepting prescriptions. Acer anticipates publishing the OLPRUVA™ list price, or wholesale acquisition cost (WAC), in mid-to-late May.

“Since the FDA approval of OLPRUVA™ at the end of 2022, we and our partners have been working diligently to bring this innovative treatment option to UCD patients in need as soon as possible,” said Chris Schelling, chief executive officer and founder of Acer. “As a result of these efforts, I am pleased to report we are ahead of our anticipated launch schedule and now expect drug availability beginning in mid-June 2023. We have also made significant progress in our ongoing discussions with payers regarding reimbursement, increased physician awareness and interest and built out our patient support and fulfillment program. We look forward to continued progress across these and other launch initiatives and to delivering OLPRUVA™ to patients starting in mid-June 2023, subject to additional capital.”

REIMBURSEMENT

Acer Therapeutics has been engaged with both commercial and government payers as it anticipates approximately 50 percent of OLPRUVA™ prescriptions to be reimbursed through Medicaid, 45 percent through commercial payers and 5 percent through Medicare Part D. Acer reports its representatives are in discussions with the major pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) representing a substantial majority of covered lives. Acer believes it will begin attaining OLPRUVA™ commercial insurance coverage in the second half of 2023. Acer also reported its representatives are in negotiations with Medicaid payers in key priority states with the goal of attaining reimbursement for OLPRUVA™ Medicaid patients starting in Q3 2023.

PATIENT AND PHYSICIAN AWARENESS

Acer also reports making significant progress in support of its objective to raise awareness for OLPRUVA™ as a new, alternative treatment option for certain patients with urea cycle disorders (UCDs). Most recently, Acer attended and exhibited at the 44^th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD) in March 2023. At the meeting, Acer met with 33 metabolic treatment providers ­­– including nurse practitioners, registered dieticians and physicians – from 24 metabolic treatment centers in the U.S. Of those metabolic treatment providers surveyed by Acer, 70 percent expressed a high interest in treating at least one of their patients with OLPRUVA™ in 2023. Providers surveyed also stated they viewed OLPRUVA™ as an attractive alternative therapy for UCD patients citing that despite available nitrogen scavengers in the market today, there are still unmet needs for UCD patients that may likely be addressed by prescribing OLPRUVA™.

PATIENT SUPPORT

Acer has established and staffed its patient support program, Navigator by Acer Therapeutics, which includes a suite of services designed to provide streamlined and efficient prescription management – including benefits verification, education and home delivery – and personalized support for OLPRUVA™ patients.

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.^{[1] 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) FOR ORAL SUSPENSION

In March 2021, Relief Therapeutics signed a collaboration and license agreement with Acer for the worldwide development and commercialization of ACER-001. 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 UCDs, involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).[2] 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 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 Rome. 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.
 

CONTACT:

RELIEF THERAPEUTICS Holding SA

Catherine Day
Vice President, Investor Relations & Communications
contact@relieftherapeutics.com

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. A number of factors, including whether Acer will be successful in its commercialization efforts, and those factors 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 http://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] 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.

^[2] OLPRUVA™ (sodium phenylbutyrate) for oral suspension. Prescribing information. Newton, MA: Acer Therapeutics Inc.