Company acquires an additional therapeutic product for the management of patients with PKU for worldwide markets, with the exception of the United Kingdom, thereby complementing and enhancing its existing PKU GOLIKE ® portfolio of medical products
GENEVA, SWITZERLAND / ACCESSWIRE / July 13, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF, OTCQB:RLFTF, RLFTY) (" Relief "), a biopharmaceutical company seeking to serve patients with rare metabolic and genetic diseases with unmet medical need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (" APR "), has executed a definitive agreement with Meta Healthcare Ltd. (" Meta "), acquiring the worldwide rights, except for the United Kingdom (" UK "), for a novel dosage form of a prescription drug already approved by the U.S. Food and Drug Administration (" FDA ") and intended for the treatment of patients with phenylketonuria (" PKU "). This improved product is expected to improve patient acceptance and compliance. Financial terms of the agreement were not disclosed.
As previously announced, under the terms of the agreement, Meta will provide the technology transfer package and Relief will conduct clinical studies, manufacturing, regulatory submission and commercialization in the U.S. and EU.
"The acquisition of this additional therapeutic product perfectly fits within our currently marketed portfolio of effective and patient friendly treatments for PKU, including our PKU GOLIKE ® family of products and will allow us to leverage our existing distribution platform to further serve the global PKU market," stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. "This portable, flavored, high concentration dosage form will be more attractive compared to other formulations, given that it will allow for more precise dosing for all users, particularly the pediatric patient population, and can be stored at room temperature. We anticipate submission of an Investigational New Drug (IND) application at the earliest opportunity in order to file for FDA marketing approval in the first half of 2023, followed by a product launch in the U.S and Europe a year later."
"Signing of this definitive agreement marks an important milestone, allowing us to meaningfully enhance our presence within the worldwide PKU patient community in the all-important U.S. market. Assuming U.S. FDA approval, we will be able to utilize our in-house, best-in-class salesforce, which we have steadily built throughout the current year, in anticipation of this, and a number of follow-on product launches within this therapeutic sector," stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. "This novel dosage form will compete in the $300 million PKU market in the U.S., where we believe it has the potential to capture 15%-20% of the market. We appreciate our strong working relationship with Meta, our current UK distribution partner for the PKU GOLIKE ® family of products and we look forward to a long and productive collaboration. This latest product acquisition is another example of our risk mitigated, capital efficient approach to drug development."
About Phenylketonuria or PKU
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 blood phenylalanine result in its accumulation in the brain, which could hamper 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 phenylalanine free-amino acid-mix to prevent protein deficiency and optimize metabolic control.
Relief focuses on developing and commercializing clinical-stage therapeutic assets to serve patients with rare metabolic and genetic diseases. 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). Relief also continues to study aviptadil for several pulmonary indications. Relief's 2021 acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH has delivered to Relief a diverse pipeline of marketed and development-stage therapeutic assets.
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
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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 (i) whether the acquisition of commercialization rights for the product to be acquired from Meta will be completed, (ii) whether if the product is acquired, the timelines for filing for regulatory approvals for the product described above will be met, (iii) whether the product will be approved for commercialization such that the product can be launched in the U.S. and Europe sometime during the first half of 2024, (iv) whether PKU GOLIKE ® will ever be approved for commercialization in the U.S. as a prescription product, and (v) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission, 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.
SOURCE: Relief Therapeutics Holdings AG
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