Relief Therapeutics ...
SWX:MMTX
CHF
1,06
CHF
CHF-1,83 (-63,32%)
1,06
CHF
CHF-1,83 (-63,32%)
End-of-day quote: 12/15/2025
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Relief Therapeutics Holding Company Info
EPS Growth 5Y
-19,90%
Market Cap
CHF0,01 B
Long-Term Debt
CHF0,00 B
Quarterly earnings
04/02/2026
Dividend
CHF0,00
Dividend Yield
0,00%
Founded
2013
Industry
Country
Website
ISIN Number
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
There are currently no price targets available for this stock.
In the last five quarters, Relief Therapeutics Holding’s Price Target has risen from CHF129,60 to CHF129,60 - a 0,00% increase.
Top growth stocks in the health care sector (5Y.)
What does Relief Therapeutics Holding do?
Relief Therapeutics Holding SA (Relief) operates as a commercial-stage biopharmaceutical company.
The company focuses on the identification, development, and commercialization of novel, patent protected products intended for the treatment of metabolic, dermatological, and pulmonary rare diseases with a portfolio of clinical and marketed products that serve unmet patient needs.
Historically, the company had a diversified portfolio of marketed products and developmental product candidates many o...
Relief Therapeutics Holding SA (Relief) operates as a commercial-stage biopharmaceutical company.
The company focuses on the identification, development, and commercialization of novel, patent protected products intended for the treatment of metabolic, dermatological, and pulmonary rare diseases with a portfolio of clinical and marketed products that serve unmet patient needs.
Historically, the company had a diversified portfolio of marketed products and developmental product candidates many of which use its proprietary drug delivery platform technologies which the company allows for improvements in efficacy, safety or convenience to benefit the lives of patients. Following a comprehensive review of the company’s commercial and clinical product portfolio, it is actively pursuing a strategy of refocusing its business on products addressing rare conditions in the dermatological therapeutic area where the company is considerable unmet need. For the company’s other commercial and development stage products in its portfolio, it is actively seeking potential partners throughout-licensing, divestitures or other collaboration transactions.
On March 21, 2024, the company entered into an exclusive license and supply agreement with Eton Pharmaceuticals, Inc. for the commercialization of the GOLIKE family of products in the United States. As the company’s transition to a business-to-business strategy for selected commercial and development stage products, the company is focusing its efforts on advancing RLF-TD011, an acid oxidizing solution of hypochlorous acid that is self-administered, sprayable, and is being studied for the treatment of wounds in epidermolysis bullosa. RLF-TD011 was developed using the company’s proprietary, patented TEHCLO Nanotechnology platform.
Strategy
The company’s targets established products with a proven history of safety and efficacy and either initial human therapeutic activity, proof-of-concept or a strong scientific rationale, allowing for relatively short, capital-efficient clinical trials with clear endpoints. The company’s research and development resources are directed toward optimizing the therapeutic potential of these assets to deliver improvements in efficacy, safety and convenience through the application of its proprietary platform technologies, drug delivery systems or novel dosage forms.
The company’s strategy plans leverage its clinical trial and business development expertise to establish and grow its business in rare dermatologic disorders with high unmet need. The company intends to use its product portfolio in rare metabolic and respiratory diseases through partnerships and collaborations to generate cash flow in support of investments in the rare dermatological therapeutic area.
Product Portfolio and Pipeline
The company’s portfolio consists of a balanced mix of marketed, revenue-generating products and globally patented drug delivery platform technologies. The company’s pipeline spans three core therapeutic areas: rare dermatological disorders, rare metabolic disorders, and rare respiratory diseases.
Rare Dermatologic Disorders
The company is committed to developing product candidates in rare dermatological disorders which is an area of high unmet need where its developmental expertise and platform technology offer the opportunity to improve patient outcomes and quality of life. RLF-TD011 is being studied for the treatment of epidermolysis bullosa where patients have relatively few optimal treatment options.
TEHCLO Nanotechnology
The TEHCLO Nanotechnology platform (TEHCLO), used in the development of RLF TD011, is its proprietary, globally patented technology. Characterized by its nanocoated electrodes, this technology enables the production of a highly stable electrolytic water resulting in a hypochlorous acid solution that is low in pH, isotonic, and oxidizing.
The company’s TEHCLO intellectual property portfolio consists of three patent families. The first two families include 40 granted patents worldwide directed to systems and methods for generating its hypochlorous acid solutions. These patents expire between October 2026 and February 2030, exclusive of any patent term adjustments or extensions, or any form of potential exclusivity. A third patent family will cover certain medical uses, and if granted, will expire no earlier than July 2040.
VYJUVEK, was approved by the FDA on May 19, 2023, for the treatment of DEB, and the company Krystal Biotech, Inc. (NASDAQ: KRYS) subsequently initiated the U.S. commercial launch. VYJUVEK is the first medicine approved by the FDA for the treatment of DEB. VYJUVEK is a re-dosable, off-the-shelf gene therapy designed to deliver two copies of the COL7A1 gene when applied topically, directly onto an open wound. Unlike the previous standard of care, VYJUVEK treats DEB at the molecular level by providing patient’s skin cells the template to produce normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
FILSUVEZ was approved by the FDA on December 19, 2023. It is a topical gel indicated for the treatment of partial thickness wounds in patients six months and older with JEB and DEB. FILSUVEZ contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid. The topical gel is applied on the wound and covered by a wound dressing.
The standard of care for EB patients includes wound management to prevent infection, pain management to reduce discomfort, and nutritional support to promote healing. This involves careful wound cleaning and disinfection to minimize the risk of infection. Gentle cleansing of the affected areas with mild, non-irritating solutions helps remove bacteria and other pathogens from the wound surface. Antibiotics may be used to prevent and treat infections, while analgesics are prescribed for pain relief.
RLF-TD011 for the Potential Treatment of Epidermolysis Bullosa
The company’s developing RLF-TD011 as a differentiated acid oxidizing solution of hypochlorous acid (HCIO) that combines strong antimicrobial action with anti-inflammatory properties, thereby allowing for infection control, reduction of wound colonization and improved wound healing. The company’s RLF TD011, if approved, may be a fast, easy to use, and effective treatment for EB wound care management. Importantly, RLF-TD011 could also enhance the efficacy and usability of newly developed EB treatments given its unique properties.
Developed with the company’s proprietary, patent-protected TEHCLO Nanotechnology, RLF-TD011 employs an exclusive combination of four physio-chemical properties—high-purity HCIO, hypotonic, low pH and high oxidation-reduction potential, which the company can support a faster physiological healing of wounds by creating a favorable wound microenvironment. HCIO is well known as a broad-spectrum, fast acting antimicrobial agent, which reinforced by low pH and high ORP contributes to the prevention and treatment of skin infections.
RLF-TD011 is a self-administered, sprayable solution enabling targeted application while avoiding skin contact and cross-contamination. Wound care remains the cornerstone of treatment for patients with EB, potentially facilitating a rapid and natural wound healing, while minimizing or preventing infections (and thereby reducing the reliance on antibiotics), and avoiding or limiting the chronicization of wounds.
RLF-TD011 could also be effective in reducing skin inflammation by (i) inhibiting the NF-kB pro-inflammatory pathway, and (ii) irreversibly inactivating the main pro-inflammatory proteases MMP- 2.
In 2019, RLF-TD011 was granted Orphan Drug Designation (ODD) by the FDA for the treatment of EB, which qualifies the sponsor of the treatment for certain development incentives, including seven-year marketing exclusivity after FDA marketing approval is received.
In February 2023, the company announced the first three patients were enrolled in a proof-of-concept, investigator-initiated study to evaluate RLF-TD011 as a treatment for EB (NCT05533866). The primary aim of this study is to assess changes in the skin microbiome before, during and after treatment with RLF TD011. Patients with dystrophic or junctional EB whose wounds are colonized by staphylococcus aureus, pseudomonas aeruginosa or commensal organisms, were treated with RLF-TD011 for eight weeks followed by discontinuation of treatment for four weeks with assessment of their wound microbiome at each stage. As of the date of this annual report, the study has completed enrollment and treatment of patients. The results are expected in mid- to late-2024. Subject to a positive outcome, the company intends to engage in consultations with the Food and Drug Administration (FDA). These discussions will aim to finalize and validate the company’s development and regulatory plan, ensuring an efficient path to market approval.
Rare Metabolic Disorders
PHYSIOMIMIC Technology
The Physiomimic Technology, used in the development and manufacturing of the company’s GOLIKE product line, is its proprietary globally patented technology. Through a complex coating process, this technology alters the release and absorption profile of amino acids, mimicking the physiological absorption of natural proteins. This unique approach reduces the inherent taste and odor of amino acids and increases their nutritional value compared to standard free amino acids available on the market.
The company’s Physiomimic Technology intellectual property portfolio consists of two patent families including 14 pending applications and 36 granted patents worldwide. Patents resulting from these families, if granted, will expire no earlier than 2036 and 2038, respectively, exclusive of any patent term extensions and other potential market exclusivity.
PKU GOLIKE for the Dietary Management of PKU
Patients with PKU require supplementation of AA-based foods for special medical purposes (FSMPs or Medical Foods) to prevent protein deficiency and optimize metabolic control. However, Medical Foods may result in poor dietary compliance due to their taste and odor. Further, the often-unpleasant odor and aftertaste of AA supplements can become a barrier to social interaction for PKU patients.
PKU GOLIKE products are Phe-free (or low Phe content) Medical Foods for children and adults and are the first prolonged-release AA Medical Food. They are characterized by a special coating that ensures a physiological absorption mirroring natural proteins’ absorption profile. The special coating also masks the unpleasant taste, odor, and aftertaste of the AAs. PKU GOLIKE granules are flavorless and can be mixed with many foods. PKU GOLIKE products contain 19 amino acids that PKU patients need to maintain neurological and muscular health and are fortified with vitamins and minerals, including iron, calcium, and vitamin B12 which are normally contained in protein-rich foods.
In 2023, Relief released pre-clinical and clinical data on PKU GOLIKE, demonstrating the product’s ability to decrease catabolic events and lower blood Phe levels. Additionally, the data indicated a reduction in gastrointestinal discomfort among patients with phenylketonuria (PKU).
The company is conducting two sponsored, randomized, controlled, studies in PKU patients to demonstrate additional benefits in Phe fluctuations with PKU GOLIKE versus standard free AA products (study numbers GLK-IT-2023 and GLK-UK-2021) and expect to report the results in 2024. The company’s results, if positive, may allow for increased utilization of its PKU GOLIKE products.
The company’s products are available in convenient packets of flavorless granules (PKU GOLIKE Plus for ages 3-16 and ages 16+), medical food bars (PKU GOLIKE BAR) and tablets to be chewed (PKU GOLIKE KRUNCH). The company also developing PKU GOLIKE products in additional solid and liquid forms based on the same technology. PKU GOLIKE products have been commercially available in Europe since 2018 and in the U.S. since October 2022.
Following the company’s business-to-business strategy, it granted Eton Pharmaceuticals, Inc. an exclusive license on March 21, 2024, for the commercialization of the GOLIKE family of products in the United States. The company’s actively pursuing similar licensing arrangements for the commercialization of GOLIKE in key European markets.
RLF-OD032 for the Treatment of PKU
RLF-OD032 is a novel liquid formulation of a Sapropterin dihydrochloride product in oral suspension to reduce blood phenylalanine (Phe) levels in adult and pediatric PKU patients. If approved, RLF-OD032 would be the first and only liquid formulation of a Sapropterin dihydrochloride product.
Sapropterin dihydrochloride is a pharmaceutical version of the tetrahydrobiopterin (BH4) molecule. It enhances phenylalanine hydroxylase (PAH) enzyme activity in Sapropterin-responsive PKU patients and, in conjunction with dietary management, helps lower blood Phe concentrations. It has been widely demonstrated that increased Phe tolerance and reduced Medical Food requirement improves patients’ stress of a strict diet and quality of life.
The company remains a significant unmet need to provide additional benefits to PKU patients. The large volume of solid products needed to be consumed daily by patients and the need to tailor treatment quantities based on patient’s weight render the treatment challenging, especially in the pediatric population, thereby affecting patient compliance. If approved, the company’s liquid suspension product may improve patients’ acceptance and compliance by reducing the amount of drug product that must be consumed compared to other generic versions of Sapropterin dihydrochloride. Low volume and no mixing requirement make RLF-OD032 a more convenient administration form compared to the existing dosage forms and would be administered orally via a metered syringe, thereby offering significant improvement in the management of PKU in newborns, children and adults.
Relief acquired RLF-OD032 worldwide rights, except in the UK, from Meta Healthcare Ltd in 2022. The company has since developed RLF-OD032’s formulation for clinical and potential commercial use and are preparing the initiation of a Pilot PK Trial in mid-2024. Upon completion of a Pivotal PK Trial, the company expects to file an 505(b)(2) NDA with the FDA. If approved, it intends to divest or out-license this product.
GOLIKE for the Dietary Management of TYR and HCU
TYR and HCU require lifelong diets with significant compliance challenges, often due to the poor palatability of AAs and the suboptimal nutritional value from the fast absorption of standard products. Given the limited range of products available for these rarer diseases, GOLIKE can offer substantial benefits to patients.
TYR GOLIKE products are Phe-free and Tyrosine-free (or Phe and Tyrosine low content) Medical Foods. HCU-GOLIKE products are Methionine (Meth) free (or Meth low content) Medical Foods. Both product lines are developed with the company’s Physiomimic Technology drug delivery platform and intend to address both children and adults’ dietary needs.
The company anticipates the development and regulatory completion of GOLIKE for the dietary management of TYR in 2025 and of HCU in 2026. If approved, these products will be commercialized through licensees.
Urea Cycle Disorders (UCDs)
OLPRUVA (sodium phenylbutyrate)for oral suspension
OLPRUVA is a proprietary and novel formulation of sodium phenylbutyrate powder, packaged in pre-measured single-dose envelopes, that has shown bioequivalence to existing sodium phenylbutyrate powder but with a pH-sensitive polymer coating that is designed to minimize dissolution of the coating for up to five minutes after preparation.
OLPRUVA was approved in the U.S by the Food and Drug Administration in December 2022 as an adjunctive therapy for the long-term management of UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), orargininosuccinic acid synthetase (AS). OLPRUVA is marketed in the U.S. by Acer Therapeutics, Inc. (Acer), a wholly owned subsidiary of Zevra Therapeutics, Inc. (NASDAQ: ZVRA).
Additionally, the company holds exclusive development and commercialization rights of OLPRUVA within Europe.
The commercialization of OLPRUVA in Europe through partnerships is contingent on evidence of commercial viability and the performance of a bridging PK study for regulatory purposes.
Treatment Options for UCDs
Sodium phenylbutyrate (NaPB) is approved in the U.S. and the EU to treat patients with UCDs, which is marketed as BUPHENYL (sodium phenylbutyrate) Tablets, BUPHENYL (sodium phenylbutyrate) Powder and RAVICTI (glycerol phenylbutyrate) Oral Liquid. While a study provided by Horizon Therapeutics, Inc. in the RAVICTI package insert involving 46 adults with UCD demonstrated that BUPHENYL and RAVICTI were similarly effective in controlling the blood level of ammonia over a 24-hour period, many patients who take their medicine orally prefer RAVICTI, as it is significantly more palatable than BUPHENYL. However, the very high annual treatment cost of RAVICTI, based on patient weight, is often prohibitive. RAVICTI and BUPHENYL are registered trademarks owned by or licensed to Horizon Therapeutics plc. Phenylburate is also marketed in the U.S., Europe, Australia and New Zealand under the trade name PHEBURANE (sodium phenylbutyrate) Oral Pellets. AMMONAPS (sodium phenylbutyrate) Tablets, another formulation of NaPB that claims to be tasteless and odor free is approved and marketed in Europe.
Pulmonary Diseases
RLF-100 (Aviptadil acetate)
Aviptadil acetate is a synthetic form of vasoactive intestinal peptide (VIP) consisting of 28 amino acids.
It is predominantly localized in the lungs and a vast body of experimental, pharmacological, as well as clinical evidence suggests Aviptadil to be an attractive candidate as a treatment option for pulmonary disorders.
The company has developed its proprietary and patent-protected stable Aviptadil formulations (codenamed RLF-100), intended for intravenous (IV) and inhaled administration as standard of care for the prevention and treatment of respiratory failure and its complications in both the acute intensive care and chronic ambulatory settings. Based on the latest Aviptadil stability results, the company has filed a US Patent Application and a PCT Patent Application.
ARDS
ARDS is a devastating clinical syndrome of acute respiratory failure with progressive arterial hypoxemia, dyspnea, and a marked increase in the work of breathing with a need for mechanical ventilation.
Aviptadil was granted U.S. Food and Drug Administration (FDA) Fast Track Designation for treating critical COVID-19-induced ARDS. It has been recently tested in IV or inhaled forms in several clinical trials:
Phase 2 and 3 studies were conducted with Aviptadil during the COVID pandemic with mixed results A Phase 2b/3 multicenter study did not reach its primary end point but demonstrated a statistically significant two-fold decrease in mortality and a significant improvement in respiratory distress ratio (Youssef et al. 2022). This finding was deemed ‘hypothesis generating’ by the US FDA and insufficient to warrant Emergency Use Authorization. Aviptadil was further evaluated for improving treatment of severely and critically ill COVID-19 patients in the I-SPY COVID-19 trial and the TESICO trial but was withdrawn from these two studies before completion.
A Phase 3 randomized, multicentric, double-blind, placebo-controlled, comparative clinical trial (150 participants) with severe COVID-19-induced ARDS conducted in India by an unrelated third-party on a different formulation of Aviptadil reported that Aviptadil was safe and effective in improving the resolution of respiratory failure, shortening the time to recovery, decreasing respiratory distress, and preventing death in respiratory failure patients (Dewan and Shinde, 2022). In comparison to placebo, patients on Aviptadil demonstrated a 2.1-fold increase (p=0.0410) of being free of respiratory failure (no oxygen requirement) at day 3 and a 2.6-fold increase (p=0.0035) at day 7. While this was not the company’s study, its results support the proposition that Aviptadil may be an effective treatment for treating ARDS.
A retrospective observational study evaluating Aviptadil in severe viral-related ARDS demonstrated an improvement of clinical outcomes (Sampley et al. 2023). Six patients who developed ARDS after viral pneumonias, have been treated with 3 days of infusion. Mean oxygen saturation significantly improved from 87.86% before the first Aviptadil dose to 93.43% afterward. Similarly, PaO2 values rose from 54.3 to 68.4 post-therapy (p-value < 0.004) and the SpO2/FiO2 ratio from 149 to 336 post-therapy (p-value < 0.003).
A Phase 1 trial showed promising results in treating sepsis-related ARDS (JP Youssef et al. 2020). Eight patients under mechanical ventilation were treated with IV Aviptadil for 12 hours. Seven demonstrated a successful course during intensive care and were successfully removed from mechanical ventilation and discharged from intensive care. Of those who were discharged from the ICU, six demonstrated successful 30-day survival and serum levels of TNF decreased in five patients. Hypotension was seen in association with two infusions and diarrhea in association with one but did not necessitate cessation of therapy.
Additionally, Aviptadil has showed promising results in a recent case series of severe ARDS cases with rapid deterioration of clinical conditions (Mehta et al. 2024). There can be no assurance that Aviptadil will ever be approved for commercialization in the treatment of ARDS.
Chronic lung diseases (CLDs)
The company continues to assess the development of inhaled RLF-100 for targeted CLDs, including pulmonary sarcoidosis, checkpoint inhibitor-induced pneumonitis (CIP) and chronic berylliosis. These indications are generally classified as granulomatous chronic lung diseases due to their similar pathogenesis resulting in the formation of lung granulomas. It is a process driven by an exaggerated immune response, wherein the activation of CD4+ Th1 and Th17 cells leads to the development of pro-inflammatory cytokine storms and lung granuloma formation.
The company’s inhaled RLF-100 can bind to the receptor VPAC1 on CD4+ Th1 and Th17 immune cells, thus inhibiting NF-kB (Martinez et al., 2019). NF-kB (Nuclear Factor kappa-light-chain-enhancer of activated B cells) is a protein complex that plays a crucial role in regulating the immune response to infection.
The company recently developed a new Aviptadil drug product for inhaled administration, based on its stable formulation. In alignment with the company’s development strategy and regulatory requirements, it anticipates completing certain pre-clinical demonstrations with this drug product before initiating clinical development in CLDs.
As the company is focusing on rare dermatological disorders, it will be seeking partnerships or collaborations to continue the development of its formulations for Aviptadil. However, there can be no assurance that Aviptadil will ever be approved for commercialization.
Legacy Products
The company’s legacy products are revenue-generating, approved products marketed in various countries, including the U.S. and Europe, originally developed and patented by Relief and subsequently licensed to third parties for commercialization in different territories.
CAMBIA
Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug (NSAID) widely used for treating inflammatory conditions and pain management. By applying the company’s patented Dynamic Buffering Technology (DBT), it developed the first and only NSAID approved by the FDA for the treatment of acute migraine attacks with or without aura in adults. CAMBIA is available in the form of a powder packed into a single dose envelope to be poured and dissolved in water before administration. The product is marketed in the U.S. as CAMBIA by Assertio Therapeutics Inc. (Nasdaq: ASRT) and in Canada by Aralez Pharmaceuticals Canada Inc.
CAMBIA is protected by a family of four patents listed in the FDA Orange Book, all expiring in 2026. In 2023, based on litigation settlements between Assertio Therapeutics Inc. and specific generic filers, generic versions at of CAMBIA became available in the U.S., significantly reducing its royalty income from CAMBIA.
SETOFILM/ONDISSOLVE
SETOFILM is the first prescription-only medicine approved in Europe and Canada, developed as an orodispersible film (ODF) formulation. The product is available in 4 mg and 8 mg doses. Once placed on the tongue, it dissolves in a few seconds and is swallowed with saliva without the need for water. The innovative ODF form may reduce the patient pill burden and enable patients to take their medication virtually anywhere.
The product is indicated for radiotherapy induced nausea and vomiting (RINV), chemotherapy induced nausea and vomiting (CINV), as well as postoperative induced nausea and vomiting (PONV) in both adults and children 6 months of age or older. The product has been formulated and developed using the RapidFilm drug delivery technology and is the form of a soluble film to be placed on the tongue where it dissolves in a few seconds thus greatly improving patient compliance and avoiding possible risks of suffocation in kids.
The product is marketed in Europe by Norgine B.V and in Canada by Takeda Pharmaceuticals.
VOLTADOL
Developed with the company’s patented matrix patch technology, Voltadol is a topical, locally applied, and locally acting patch delivering diclofenac sodium, an off-patent, potent non-steroidal anti-inflammatory drug (NSAID) for the local treatment of painful, acute conditions, such as muscle and joint strains. Unlike heat plaster, the patch contains an anti-inflammatory. It penetrates deep to the source of pain to provide powerful pain relief. The medicated patch provides up to two times more powerful deep pain relief, compared to a non-medicated, non-heated placebo patch. The patch also provides 12 hours continuous release of the active ingredient (diclofenac) to the site of pain. This means the patch only needs to be applied once in the morning and once in the evening to provide effective pain relief. The product is marketed in various countries as an over-the-counter medicine by GlaxoSmithKline (GSK) which recently spun-off the rights to Haleon.
Discontinued Products
In 2023, the development of Sentinox was discontinued due to a decrease in market needs as the COVID-19 pandemic subsided. Commercialization efforts for Nexodyn, a hypochlorous acid-based spray solution for wound management, have also been discontinued. Neither Sentinox nor Nexodyn significantly contributed to the company’s revenue.
Third-Party Agreements
The company’s party to certain agreements with third parties relating to licensing, collaboration, or other matters that are material to its business and performance.
OLPRUVA License
On January 25, 2021, the company entered into an option agreement with Acer Therapeutics, Inc. (Acer) providing exclusivity for the right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001 (OLPRUVA) for the treatment of UCDs, MSUD, and other potential indications. Under the terms of the option agreement, the company paid Acer a USD 1 million non-refundable payment in return for exclusivity until June 30, 2021, to negotiate and enter into a collaboration and license agreement for the development of ACER-001.
In December 2022, ACER-001 was approved in the U.S by the Food and Drug Administration. under the trademark OLPRUVA, for the treatment of Urea Cycle Disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
Relief holds exclusive development and commercialization rights for OLPRUVA in the European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia (Geographical Europe). Furthermore, Relief returned to Acer development and commercialization rights for non-US-territories, excluding Geographical Europe where Relief retained these rights.
On November 17, 2023, Zevra Therapeutics, Inc. (NASDAQ: ZVRA) (Zevra), completed its acquisition of Acer. Zevra confirmed its assumption of Acer’s obligations under the termination agreement referenced above and (the exclusive license agreement) ELA. As of the date of this annual report, Acer is a wholly owned subsidiary of Zevra.
License and Supply Agreement with Eton Pharmaceuticals, Inc.
On March 21, 2024, the company entered into a license and supply agreement granting the exclusive right to Eton Pharmaceuticals, Inc. (Nasdaq: ETON) (Eton) for the commercialization of GOLIKE family of products in the United States. As part of the agreement, Eton also received U.S. rights to Relief’s GOLIKE medical food line extensions under development for the management of other inherited rare metabolic diseases, such as tyrosinemia and homocystinuria. For an initial term of six years, Relief committed to manufacture and supply GOLIKE products for the U.S., with renewals possible for three-year periods.
Acquisition and license agreement with Meta Healthcare Ltd
On July 11, 2022, the company acquired from Meta Healthcare Ltd. (Meta) the worldwide rights, except for the United Kingdom, of RLF-OD032, a liquid formulation of a Sapropterin dihydrochloride product intended for the treatment of patients with phenylketonuria. Under the terms of the agreement, the company paid Meta approximately CHF 0.3 million prior to certain subsequent price adjustments and may issue additional payments of approximately CHF 0.3 million contingent to pre-specified development milestones.
Share Subscription Facility with GEM
On January 20, 2021, the company signed a binding agreement with its largest shareholder, GEM Global Yield LLC SCS and GEM Yield Bahamas Limited (GEM) for the implementation of a new share subscription facility (SSF) in the amount of up to CHF 50 million for a duration of up to three years. On February 27, 2024, the SSF agreement was extended until January 20, 2027.
Pursuant to the extension agreement dated February 27, 2024, GEM agreed to forgive the commitment fee and accrued interests. The issuance of these warrants was contingent upon shareholder approval for a reduction in the nominal value of the company’s ordinary shares. At the extraordinary general meeting held on April 26, 2024, such reduction was approved, and the warrants will be formally issued upon the registration of the reduction in nominal value with the commercial register of Geneva, Switzerland.
Acquisition of APR Applied Pharma Research SA
On June 28, 2021, the company signed and closed a definitive agreement for Relief to acquire all outstanding shares of APR Applied Pharma Research SA (APR), a privately held Swiss company with over 25 years of experience in identifying developing and commercializing known molecules engineered with drug delivery systems in niche and rare diseases.
Acquisition of AdVita Lifescience GmbH
On July 28, 2021, the company announced the closing of a definitive agreement to acquire all the outstanding shares of AdVita Lifescience GmbH (AdVita). AdVita was founded in 2019 for the purpose of developing products and strategies to improve the therapy and diagnosis of rare lung diseases. Among AdVita’s assets were intellection property rights that could cover RLF-100 inhaled formulation specifications and the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome, Checkpoint Inhibitor-induced Pneumonitis and Sarcoidosis.
Collaboration Agreement with InveniAI LLC
On November 24, 2021, the company announced that it had entered into a collaboration agreement with InveniAI LLC (InveniAI), a U.S. based company that has pioneered the application of artificial intelligence and machine learning across biopharma and other industries, in order to identify promising drug candidates to treat rare and specialty diseases.
NeuroRx Collaboration Agreement
On September 18, 2020, the company entered into a binding collaboration agreement (the Collaboration Agreement) with NeuroRx. The Collaboration Agreement established the terms under which the company will collaborate and assist with NeuroRx in order to maximize revenues in its respective territories from the sale of RLF-100 for intravenous and inhaled use primarily in the treatment of COVID-19 related conditions. The NeuroRx territory included the U.S., Canada, and Israel. The Relief territory comprised the rest of the world and includes the EU, Switzerland, Iceland, Norway, the UK, the Channel Islands, Liechtenstein, Monaco, Andorra, San Marino and Vatican City. The Collaboration Agreement provided that the company would fund the costs associated with the clinical trials and development of RLF-100 (aviptadil acetate) in the U.S., which development would be conducted and managed by NeuroRx. NeuroRx was responsible for ensuring that the costs of the clinical trials and development activities for RLF-100 IV did not exceed the budget contemplated by the parties by more than 30 percent. The Collaboration Agreement also provided options for the parties to treat health conditions outside COVID-19 and for the commercialization of RLF-100 outside of the above-described territories.
Intellectual Property
Aviptadil Acetate/RLF-100 Patents
As of December 31, 2023, the company has two groups of patent families covering formulations of Aviptadil acetate.
The first group includes a U.S. patent that will expire in July 2029, with extension opportunities up to five years, as well as patents in several countries in Europe and the rest of the world valid until at least 2026, excluding extension opportunities comparable to the U.S. The first family applications were filed in 2006 and granted between 2011 and 2012. The second family includes a pending U.S. provisional and a PCT application.
In the second group, the company has three patent families in various stages of prosecution. The first family includes one granted patent and four applications claiming priority to PCT/EP2020/062420. The patent and any patents granted from the pending applications claiming priority to PCT/EP2020/062420 will expire in May 2040, excluding any patent term adjustments or extensions, or any form of potential exclusivity. The second family includes 15 applications world-wide claiming priority to PCT/EP2021/052151. Patents granted from applications claiming priority to PCT/EP2021/052151 will expire in January 2041, excluding any patent term adjustments or extensions, or any form of potential exclusivity. The last family includes three applications claiming priority to PCT/IB2022/053709. Patents granted from applications claiming priority to PCT/IB2022/053709 will expire in April 2042, excluding any patent term adjustments or extensions, or any form of potential exclusivity.
TECHLO Technology
As of December 31, 2023, the company’s TEHCLO portfolio consists of three patent families. The first two families include 40 granted patents worldwide directed to systems and methods for generating hypochlorous acid solution and compositions comprising its hypochlorous acid solution. These patents expire between October 2026 and February 2030, exclusive of any patent term adjustments or extensions, or any form of potential exclusivity. If granted, additional patents of the third family would expire no earlier than July 2040.
Physiomimic Technology - GOLIKE
As of December 31, 2023, the GOLIKE portfolio consists of two patent families, including 14 pending applications and 36 granted patents worldwide. Patents resulting from these families, if granted, will expire no earlier than 2036 and 2038, respectively, exclusive of any patent term adjustments or extensions, or any form of potential exclusivity.
RLF-OD032– Sapropterine suspension
As of December 31, 2023, the RLF-OD032 portfolio consists of one Patent Family:
Dynamic Buffer Technology – Diclofenac
As of December 31, 2024, the company’s diclofenac patent portfolio consists of multiple patent families comprising 44 granted patents worldwide, with expiration dates ranging from 2026 to 2040, exclusive of any patent term adjustments or extensions, or any form of potential exclusivity. The portfolio further includes 8 pending applications. If granted, patents resulting from these pending applications will expire between 2026 and 2041, exclusive of any patent term adjustments or extensions, or any form of potential exclusivity.
The company licensed Diclofenac Potassium 50 mg Powder for Oral Solution to Assertio Therapeutics (Cambia) and to Novartis (Voltaren/Voltfast).
Oral Disposable Film—Ondansetron
As of December 31, 2023, the company’s Ondansetron patent portfolio consists of one patent family.
In-licensed OLPRUVA Patents
Pursuant to the company’s exclusive license agreement with Acer Therapeutics Inc., it holds exclusive development and commercialization rights for OLPRUVA in Geographical Europe (European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia). The company has a license/sublicense on the following patents:
Title: Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof
Assignee: Acer Therapeutics Inc.
Priority Application Number: U.S. Prov. Appl. No. 62/308,614
Priority Date: March 15, 2026
Title: Taste Masked Phenylbutyrate and Compositions Therefore
Assignee: Acer Therapeutics Inc.
Priority Application Numbers: U.S. Prov. Appl. Nos. 63/048,892 & 63/065,272
Priority Dates: July 7, 2020 (August 13, 2020)
Title: Dosage Form for Improving Palatability of Drug Substance
Assignee: Acer Therapeutics Inc.
Priority Application Number: 63/232,011
Priority Date: August 11, 2021
Title: Method of Modulation of Branch Chained Acid and Uses Thereof
Assignee: Baylor College of Medicine
Priority Application Number: 61/228,485
Priority Date: July 24, 2009
Other In-licensed Patents
The company received a sublicense right in the territory of U.S. and China from Fidia Farmaceutici in relation to the following patents owned by IBSA Farmaceutici on Diclofenac transdermal patch:
Chinese Patent No. CN101001616B;
U.S. Patent No. 10,328,034.
Other IP
In addition to the patents and applications described above, the company also has:
A sublicense right in the U.S. and China from Fidia Farmaceutici in relation to the following patents owned by IBSA Farmaceutici on Diclofenac transdermal patch: Chinese Patent No. CN101001616B; U.S. Patent No. 10,328,034.
A patent in Italy and applications in the United States (Application No. 18/044,358), Canada, and the European Patent Convention (all titled ‘Dermal Compositions Replicating the Vernix Caseosa’) that cover and claim OTC formulations targeting atopic dermatitis, as well as other moderate skin disorders.
Commercialization
The company maintained an internal marketing and sales infrastructure in Switzerland, the U.S., Italy and Germany, dedicated to the direct commercialization of PKU GOLIKE. For the commercialization of the company other commercially available products, as well as PKU GOLIKE outside of these key markets, it entered into licensing or distribution agreements with third parties. In December 2023, the company decided to transition progressively from its direct marketing and sales infrastructure to a partnership-based model for PKU GOLIKE to enable more efficient patient access through leveraging external expertise and infrastructure.
On March 21, 2024, the company entered into a license and supply agreement granting the exclusive right to Eton Pharmaceuticals, Inc. (Nasdaq: ETON) for the commercialization of GOLIKE family of products in the United States. As of the date of this annual report, the company is in active discussions with potential licensees for the commercialization of PKU GOLIKE in certain European countries.
As the company moves its product candidates through development toward regulatory approval, it intends to enter into strategic marketing partnerships with third parties, including other pharmaceutical or biotechnology companies. The company’s approach is tailored to leverage both its internal capabilities and strategic partnerships to ensure efficient and widespread patient access to its future therapies.
Regulation in the United States
The company assumes that some of its product candidates will be submitted under a new drug application (NDA) and that approval of not only the products but also their manufacture is required before starting to market them.
Additionally, if the company fails to comply with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security and breach notification standards.
The Committee for Medicinal Products (CHMP) and other committees are also responsible for providing guidelines and have published numerous guidelines that may apply to the company’s product candidates.
History
Relief Therapeutics Holding SA was founded in 2013. The company was incorporated in 2021.
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