09 September 2021
APR Expands PKU GOLIKE® Product Line with More Convenient, Chewable Tablet Option
Geneva, Switzerland, September 9, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has launched, through its affiliates in Germany and Italy, PKU GOLIKE® KRUNCH, a convenient chewable tablet for the dietary management of phenylketonuria (“PKU”), a rare, recessive metabolic genetic disorder affecting approximately 350,000 people globally.
“With PKU GOLIKE® KRUNCH, we are directly addressing a critical patient need with a much more flexible and convenient option for the management of PKU. In particular, PKU GOLIKE® KRUNCH gives patients a ready to chew tablet allowing for ‘on-the-go’ administration of protein substitute. This new option is intended to substantially improve adherence to therapy, which is extremely difficult to maintain for these patients, leading to better outcome and quality of life,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “As important, PKU GOLIKE® KRUNCH is the result of how flexible is our patented Physiomimic Technology™, which allows to develop effective prolonged release, taste and odor masked products. We are pleased to begin sales in Germany and Italy, two key markets within the European Union, and in the coming months we plan to expand the distribution of PKU GOLIKE® KRUNCH to additional countries in Europe.”
The PKU GOLIKE® family of products are food for special medical purposes (“FSMP”) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the APR’s Physiomimic Technology™, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.
“This newest launch by APR is a testament to the strength and adaptability of the Physiomimic Technology and is a key addition to our growing line of marketed products,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “Moving forward, we plan to expand our existing commercial infrastructure and refine marketing activities to accelerate the future growth of this product line. It is also important to note that, since PKU GOLIKE® has been granted Orphan Drug Designation, we intend to assess the pursuit of PKU GOLIKE® as a prescription product for PKU in the U.S., where the majority of patients have no access to reimbursed medical foods.”
PKU is a rare inherited disorder caused by a defect of 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 hampers 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 supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,
in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
RELIEF THERAPEUTICS Holding AG
Chief Financial Officer and Treasurer
Rx Communications Group
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether APR can successfully market PKU GOLIKE® KRUNCH in Germany, Italy and other European countries, (ii) whether PKU GOLIKE® KRUNCH will ever be approved as a prescription product for PKU, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG 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.