Relief signs definitive agreement to acquire a new dosage form of a prescription drug already approved for the treatment of PKU
Company Acquires Additional Therapeutic Product for the Management of PKU Patients for Global Markets Except the UK, Complementing and Enhancing its Existing GOLIKE PKU ® 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 needs, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“ APR “), signed a definitive agreement with Meta Healthcare Ltd. (“ Meta “), acquiring worldwide rights, except for the UK (“ UK “), for a new dosage form of a prescription drug already approved by the United States Food and Drug Administration (“ FDA “) and intended for the treatment of patients with phenylketonuria (“ ECP “). 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 the clinical studies, manufacturing, regulatory submission and commercialization in the US and EU.
“The acquisition of this additional therapeutic product fits perfectly into our currently marketed portfolio of effective and patient-friendly treatments, including our PKU GOLIKE ® family of products and will allow us to leverage our existing distribution platform to better serve the global ECP market,” said Paolo Galfetti, Managing Director 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 accurate dosing for all users, especially the pediatric patient population, and can be stored at ambient temperature. We anticipate submission of an Investigational New Drug (IND) application as soon as possible to file for FDA marketing approval in the first half of 2023, followed by product launch in the United States and in Europe a year later. »
“The signing of this definitive agreement marks an important milestone, enabling us to significantly enhance our presence within the global PKU patient community in the all-important US market. Assuming US FDA approval, we will be able to use our classroom sales force, which we have steadily built up throughout the current year, in anticipation of this, and a number of follow-on product launches in this therapeutic area,” said Raghuram ( Ram) Selvaraju, Chairman of the Board of Relief, “This new dosage form will compete in the $300 million ECP market in the United States, where we believe it has the potential to capture 15 to 20% market share We appreciate our strong working relationship with Meta, our current UK distribution partner for the GOLIKE PCU ® family of products and we look forward to a long and fruitful collaboration. This latest product acquisition is another example of our risk-mitigated and capital-efficient approach to drug development. »
About Phenylketonuria or PKU
PKU is a rare inherited condition caused by a defect in the enzyme needed to break down phenylalanine, resulting in a toxic buildup of phenylalanine when eating foods containing protein or aspartame. Excess levels of phenylalanine in the blood cause it to build up in the brain, which could impair brain development and lead to neurophysiological dysfunction. Treatment for PKU is lifelong, forcing patients to follow a strict diet that severely limits phenylalanine (and therefore protein) content. This requires supplementation with the free amino acid blend of phenylalanine to prevent protein deficiency and optimize metabolic control.
Relief is focused on the development and commercialization of clinical-stage therapeutic assets to serve patients with rare metabolic and genetic diseases. Relief has entered into a collaboration and license agreement with Acer Therapeutics for the development and worldwide commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including UCD and maple syrup urinary 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 have provided Relief with 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 listed in the United States on the 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 acquisition of the rights to commercialize the product to be acquired from Meta will be completed, (ii) whether the product is acquired, filing deadlines for regulatory approvals for the product described above will be met, (iii) if the product will be approved for commercialization so that the product can be launched in the United States and Europe during the first half of 2024, (iv) if PKU GOLIKE ® will ever be approved for sale in the United States as a prescription product, and (v) the risks discussed in RELIEF THERAPEUTICS Holding SA’s press releases and filings with SIX Swiss Exchange and the Securities and Exchange Commission of the United States, 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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https://www.accesswire.com/708385/Relief-Signs-a-Definitive-Agreement-to-Acquire-a-Novel-Dosage-Form-of-an-Already-Approved-Prescription-Drug-for-the- Treatment of PKU