MindMaze Therapeutics Holding SA 6-K, filed Oct 14, 2022
MindMaze Therapeutics Holding SA (MMTZF)
About this 6-K
MindMaze Therapeutics Holding SA filed this 6-K on October 14, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the Month of October, 2022
Commission File Number: 001-41174
RELIEF THERAPEUTICS Holding SA
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of registrant's name into English)
Switzerland
(Jurisdiction of incorporation or organization)
Avenue de Sécheron 15
1202 Geneva
Switzerland
Tel: +41 22 545 11 16
(Address of principal executive offices)
Indicate by check mark if the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7) ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On October 3, 2022, Relief Therapeutics Holding SA (the “Company”) issued a press release entitled “Acer Therapeutics and Relief Therapeutics Announce Receipt of Notice of Allowance of US Patent Application Covering a Kit Comprising Phenylbutyrate and Sodium Benzoate,” a copy of which press release is attached to this Form 6-K as Exhibit 99.1.
On October 6, 2022, the Company issued a press release entitled “Relief Announces Exclusive Distributor for PKU GOLIKE® in the U.S.,” a copy of which press release is attached to this Form 6-K as Exhibit 99.2.
On October 10, 2022, the Company issued a press release entitled “Relief Announces U.S. Launch of PKU GOLIKE®,” a copy of which press release is attached to this Form 6-K as Exhibit 99.3.
On October 14, 2022, the Company issued a press release entitled “Relief Therapeutics Announces Promotion of Paolo Galfetti to Chief Operating Officer”, a copy of which press release is attached to this Form 6-K as Exhibit 99.4.
INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 99.1 | Press Release dated October 3, 2022. | |
| 99.2 | Press Release dated October 6, 2022. | |
| 99.3 | Press Release dated October 10, 2022. | |
| 99.4 | Press Release dated October 14, 2022. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
RELIEF THERAPEUTICS Holding SA
By: /s/ Jack Weinstein
Jack Weinstein
Chief Financial Officer
Dated: October 14, 2022
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Exhibit 99.1
 |
 |
Ad hoc announcement pursuant to Art. 53 LR
Acer Therapeutics and Relief Therapeutics Announce Receipt of Notice of Allowance of US Patent Application Covering a Kit Comprising Phenylbutyrate and Sodium Benzoate
Notice of allowance covering these claims further strengthens ACER-001 proprietary position in US; patent expected to be issued in Q4 2022 and expire in 2038
NEWTON, MA and GENEVA, SWITZERLAND – October 3, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief) today announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Acer for US patent application No. 16/624,834 for claims related to a kit comprising a combination therapeutic product composed of sodium phenylbutyrate or glycerol phenylbutyrate and sodium benzoate. The patent application is exclusively licensed to Acer from Baylor College of Medicine.
“This Notice of Allowance expands ACER-001’s patent protection and adds an additional component to our product expansion strategy as we evaluate how to maximize its potential,” said Jeff Davis, Chief Business Officer at Acer. “The combination of phenylbutyrate and sodium benzoate was synergistic at removing ammonia in healthy subjects based on data from a study published in Genetics in Medicine in 2018.1 As a result, this combination offers the potential to use lower drug doses of each agent while maintaining equivalent ammonia removal in urea cycle disorder patients and becomes part of our lifecycle planning for ACER-001, subject to FDA approval in this indication.”
About Phenylbutyrate and Sodium Benzoate
Phenylbutyrate and sodium benzoate are nitrogen-binding agents that are used in the prevention and treatment of hyperammonemia in patients with UCDs. Sodium benzoate for oral administration is available from compounding pharmacies and is widely used as a food preservative but has not been approved as a single agent by the U.S. Food and Drug Administration (FDA) or any regulatory authority for the treatment of UCDs. Sodium benzoate in combination with sodium phenylacetate is approved in the US and marketed as AMMONUL® (sodium phenylacetate and sodium benzoate) Injection.2
About ACER-001
ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). ACER-001 is a polymer coated formulation that, when taken within 5 minutes, helps prevent the coating from dissolving. ACER-001 has been granted orphan drug designation by the FDA for MSUD. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that ACER-001 will be approved for any indication.
About Acer Therapeutics Inc.
Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four investigational programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of viruses, including cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more information, visit www.acertx.com.
About RELIEF THERAPEUTICS Holding SA
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on 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 assets that serve unmet patient needs. Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). The FDA has accepted for review Acer’s New Drug Application (“NDA”) resubmission under the 505(b)(2) pathway for ACER-001, for oral suspension, for the treatment of patients with UCDs. The FDA designated the NDA as a Class 2 resubmission and set a PDUFA target action date of January 15, 2023. Relief also continues to develop aviptadil for several rare pulmonary indications; Relief's 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH brought to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA 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, visit www.relieftherapeutics.com Follow Relief on LinkedIn.
Reference
| 1. | Nagamani et al. A randomized trial to study the comparative efficacy of phenylbutyrate and benzoate on nitrogen excretion and ureagenesis in healthy volunteers. Genet Med. 2018 Jul; 20(7): 708–716. | |
| 2. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf |
Acer Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release, including statements regarding the expected patent issuance date and duration, our strategy, our positioning, our products and regulatory actions are forward-looking statements. Our pipeline products are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to
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project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.
Relief Forward-Looking Statements
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 (i) the intellectual property protection provided by the patent discussed above, (ii) whether the FDA will approve Acer’s NDA for ACER-001 for the treatment of UCDs, (iii) whether RELIEF THERAPEUTICS Holding SA will submit an application for approval of ACER-001 in Europe for the treatment of UCDs and the timing of filing such application, (iv) whether any application submitted to European authorities seeking marketing authorization for ACER-001 for the treatment of patients in Europe with UCDs will be approved, (v) whether the FDA will approve Acer’s IND to evaluate ACER-001 for the treatment of MSUDs, (vi) the timing of Acer’s Phase 2b trial evaluating ACER-001 for the treatment of MSUDs, (vii) whether ACER-001’s currently proposed trial and any future required trials of ACER-001 for MSUDs will be undertaken and successful, (viii) whether ACER-001 will ever be approved for the treatment of MSUDs in the United States, (ix) whether Relief will ever file the necessary applications in Europe to seek the right to commercialize ACER-001 in Europe for the treatment of MSUDs and whether any such applications filed will be granted, and (x) those other risks, uncertainties and factors 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.
CORPORATE CONTACTS
Acer Therapeutics:
Jim DeNike
Acer Therapeutics Inc.
jdenike@acertx.com
+1-844-902-6100
RELIEF THERAPEUTICS Holding SA:
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
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INVESTOR RELATIONS CONTACTS
Acer Therapeutics:
Nick Colangelo
Gilmartin Group
nick@gilmartinIR.com
+1-339-225-1047
RELIEF THERAPEUTICS Holding SA:
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com
+1-917-734-7387
# # #
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Exhibit 99.2
Ad hoc announcement pursuant to Art. 53 LR
Relief Announces Exclusive Distributor for PKU GOLIKE® in the U.S.
Leading Provider of Food for Special Medical Purposes to Help Maximize Patient Access in Support of PKU GOLIKE® U.S. Launch
Geneva, Switzerland, October 6, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis, today announced that it has hired a leading national health services company to serve as exclusive distributor of PKU GOLIKE® in the U.S. PKU GOLIKE® is a next generation medical food product engineered with the patent protected, pharmaceutical grade Physiomimic™ technology for the dietary management of phenylketonuria (“PKU”), and has been commercialized in the EU since 2019.
“Having built a team of seasoned commercial leaders with significant rare disease launch experience, the agreement completes our pre-launch preparation,” stated Raghuram (Ram) Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “With a 40-year history and strong reputation in the medical nutrition industry, our distributor will provide invaluable expertise and capabilities for the PKU patient community, fulfilling a range of critical responsibilities to maximize patient access to this important medical food innovation for the dietary management of PKU.”
Dr. Selvaraju continued, “Looking forward, in 2023, we plan to file for registration approval, via the 505(b)(2) pathway, for APR-OD032, a novel, differentiated dosage form of a prescription drug already approved by the U.S. Food and Drug Administration (“FDA”), to treat PKU. Earlier this year, we acquired worldwide commercialization rights to APR-OD32 (excluding UK) from Meta Healthcare Ltd., which represents a potential, important expansion of our commercial offerings for this patient population. This improved product is expected to enhance patient acceptance and compliance, as well as enable more convenient self or caregiver administered dosing and dispensing.”
About PKU GOLIKE®
PKU GOLIKE® is a phenylalanine-free food intended for special medical purposes (FSMP) in the U.S. The product is comprised of a mixture of amino acids in the form of granules. Engineered with Relief’s patented Physiomimic™ technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. In addition, the special coating masks the unpleasant taste, odor and aftertaste of the amino acids.
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About Phenylketonuria or PKU
PKU is a rare inherited disorder caused by a defect in the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood causes accumulation in the brain, which significantly inhibits proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and thus, protein) content. This necessitates the dietary supplementation of phenylalanine-free or low-phenylalanine medical foods to prevent protein deficiency and optimize metabolic control.
ABOUT RELIEF
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases and connective tissue disorders. Relief’s diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic™ technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (“PKU”). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”). Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa (“EB”), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.
RELIEF THERAPEUTICS Holding SA 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, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
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CONTACT: RELIEF THERAPEUTICS Holding SA Jack Weinstein Chief Financial Officer and Treasurer contact@relieftherapeutics.com |
FOR MEDIA/INVESTOR INQUIRIES: LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com |
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Disclaimer: This communication contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the commercialization of PKU GOLIKE® in the United States will be successful, and (ii) those risks discussed in Relief'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 do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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Exhibit 99.3
Ad hoc announcement pursuant to Art. 53 LR
Relief Announces U.S. Launch of PKU GOLIKE®
First sale of PKU Golike® in the U.S. through
Relief's exclusive national distributor
Relief will issue milestone payment and increase its share capital to create
200 million additional
treasury shares
Geneva, Switzerland, October 10, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis, today announced the U.S. launch of PKU GOLIKE® – a next generation medical food product engineered with the patent protected, pharmaceutical grade Physiomimic™ technology for the dietary management of phenylketonuria (PKU).
PKU is a rare inherited disorder caused by a defect in the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which significantly inhibits proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and thus, protein) content. This necessitates the dietary supplementation of phenylalanine-free or low-phenylalanine medical foods to prevent protein deficiency and optimize metabolic control. There are approximately 20,000 PKU patients in the U.S., with up to 8,000 under regular medical care.
“As the first controlled-release, taste- and odor-masked food for special medical purposes, PKU GOLIKE® offers the potential for better metabolic management and improved compliance for patients who must contend with lifelong dietary restrictions associated with PKU,” said Raghuram (Ram) Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “With our team of seasoned commercial leaders with significant rare disease launch experience in place, combined with our recently executed agreement with a leading medical nutrition provider for patient access and support services, we are well positioned to launch PKU GOLIKE® into the U.S. market and to continue our mission of commercializing best-in-class, patented products in the ultra-rare disease space.”
The launch of PKU GOLIKE® in the U.S. marks the completion of a milestone contractually agreed between Relief and the former shareholders of APR Applied Pharma Research SA. Pursuant to the June 2021 acquisition agreement, Relief will wire a cash payment of CHF 2.8 million and a share payment of approximately 150 million ordinary shares of Relief. The number of shares will be calculated as CHF 4.2 million divided by the 20-day VWAP as of the end of today. Transaction shares will be sourced from the already-issued shares constituting Relief's treasury shares reserve. To replenish such reserve, the Board of Directors has approved the issuance of 200 million shares out of Relief's authorized share capital. The new shares are fully subscribed at par value by a wholly owned subsidiary and will be listed on the SIX Swiss Exchange on or around October 17, 2022.
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About PKU GOLIKE®
PKU GOLIKE® is a phenylalanine-free food intended for special medical purposes (FSMP) in the U.S. The product is comprised of a mixture of amino acids in the form of granules, and will be available in convenient packets and medical food bars. Engineered with the company’s patented Physiomimic™ Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. In addition, the special coating masks the unpleasant taste, odor, and aftertaste of the amino acids. PKU GOLIKE® has been commercially available in the E.U. since 2019.
ABOUT RELIEF
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases, and connective tissue disorders. Relief’s diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (“PKU”). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”). The FDA has accepted for review Acer’s New Drug Application (“NDA”) resubmission under the 505(b)(2) pathway for ACER-001, for oral suspension, for the treatment of patients with UCDs. The FDA designated the NDA as a Class 2 resubmission and set a PDUFA target action date of January 15, 2023. Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa (“EB”), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.
RELIEF THERAPEUTICS Holding SA 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, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
|
CONTACT: RELIEF THERAPEUTICS Holding SA Jack Weinstein Chief Financial Officer and Treasurer contact@relieftherapeutics.com |
FOR MEDIA/INVESTOR INQUIRIES: LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com |
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Disclaimer: This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the commercialization of PKU GOLIKE® in the United States will be successful, and (ii) those factors described in Relief's reports to the SIX Swiss Exchange and the Securities and Exchange Commission could adversely affect Relief, 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 do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.
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Exhibit 99.4
Ad hoc announcement pursuant to Art. 53 LR
Relief Therapeutics Announces Promotion of Paolo Galfetti to Chief Operating Officer
Geneva, Switzerland, October 14, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis, today announced that Paolo Galfetti has been promoted to Chief Operating Officer, effective October 14, 2022. Paolo will continue his responsibilities as CEO of APR Applied Pharma Research SA (“APR”) and as a member of Relief’s Board of Directors.
“Paolo has decades of experience in the pharmaceutical sector and has been an integral part of the Relief management team since the acquisition of APR last year, and this promotion to Chief Operating Officer is a testament to his leadership,” stated Raghuram (Ram) Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “With our U.S commercial organization in place to execute the U.S. launch of PKU GOLIKE®, and as the company matures, we will continue to leverage Paulo’s expertise in business development, licensing, operational strategic management, clinical research, and pharmaceutical discovery and development.”
Mr. Galfetti added, “I eagerly anticipate taking a more active role at Relief and expanding my responsibilities globally. It is truly a pleasure to be part of such a collaborative group of dedicated professionals. In particular I look forward to contributing to the execution of the company’s overall growth strategy including the successful U.S. launch of PKU GOLIKE®, powered by our proprietary, Physiomimic™ Technology, and if approved, to the worldwide development and commercialization of ACER-001 for Urea Cycle Disorders.”
Since the acquisition of APR by Relief in June 2021, Mr. Galfetti has served as President of Relief Europe. He joined APR in 1995 as head of licensing and business development and was appointed its Chief Executive Officer in 2002. Under his leadership, APR brought its flagship PKU GOLIKE® family of products onto the market and developed a rich pipeline of product candidates. Earlier in his career, Mr. Galfetti was a founding partner, Chief Executive Officer, and board member of the Institute for Pharmacokinetic and Analytical Studies AG (IPAS), a Swiss contract research organization, Chief Executive Officer, and board member of Farma Resa s.r.l., an Italian contract research organization, and a member of several Pharma licensing groups. He is a Chartered Financial Analyst and holds a bachelor’s degree in economics from the Commercial University Bocconi, Milan, Italy.
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ABOUT RELIEF
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases, and connective tissue disorders. Relief’s diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE®, engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria (“PKU”). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”). Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa (“EB”), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.
RELIEF THERAPEUTICS Holding SA 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, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.
|
CONTACT: RELIEF THERAPEUTICS Holding SA Jack Weinstein Chief Financial Officer and Treasurer contact@relieftherapeutics.com |
FOR MEDIA/INVESTOR INQUIRIES: LifeSci Advisors Irina Koffler +1-917-734-7387 ikoffler@lifesciadvisors.com |
Disclaimer:
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, 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.
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