Relief Therapeutics' Wholly Owned Subsidiary, APR Applied Pharma Research Signs an Agreement To Acquire Rights to Commercialize a Novel Dosage Form for the Treatment of PKU
Relief Therapeutics has signed a binding term sheet with Meta Healthcare Ltd. to acquire worldwide commercialization rights (excluding the UK and Ireland) for a novel dosage form of a prescription drug approved by the FDA for treating phenylketonuria (PKU). This agreement, expected to enhance Relief's PKU GOLIKE(R) product portfolio, includes responsibilities for bioequivalence studies and regulatory submissions. The product's launch in the U.S. and Europe is anticipated in the first half of 2024, following necessary regulatory approvals.
- Acquisition of commercialization rights expands the PKU GOLIKE(R) product portfolio.
- Potential launch of the new dosage form in the U.S. and Europe in H1 2024.
- The product is designed for easy administration, appealing to a broader patient base.
- Financial terms of the agreement were not disclosed, raising concerns about the investment's scale.
- Regulatory approval timelines are uncertain, which may delay commercialization.
Company Signs Binding Term Sheet to Acquire Worldwide Commercialization Rights, Except in the United Kingdom
Expands on Existing PKU GOLIKE(R) Portfolio of Products
GENEVA, SWITZERLAND / ACCESSWIRE / March 15, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF, OTCQB:RLFTF, RLFTY) (" 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 signed a binding term sheet with Meta Healthcare Ltd. (" Meta ") to acquire the worldwide commercialization rights, except in the United Kingdom (" UK ") and Ireland, 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 "). Financial terms of the agreement were not disclosed.
Meta has completed the product's galenical and technical development and, under the agreement, will provide the technology transfer package to APR. APR will be responsible for bioequivalence studies, industrial scale up, regulatory submission and commercialization in the U.S. and EU.
APR plans to file an Investigational New Drug Application in the U.S. as soon as possible and to file for FDA regulatory approval sometime in first half of 2023. Additionally, Meta has submitted a patent application in the UK and APR intends to seek a patent extension in all major territories including the U.S. and Europe.
"Acquiring the commercialization rights to this novel dosage form from Meta not only strengthens our relationship with our current UK distribution partner for the PKU GOLIKE(R) family of products, but also immediately expands our portfolio of effective and easy-to-use treatments for those with PKU, opening additional opportunities for market penetration," stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. "This portable, flavored, dosage form allows for precise dosing and can be stored at room temperature and is easily administered to both adults, newborns and children, making it a well differentiated, highly attractive alternative to the current formulations on the market. We look forward to a potential launch of the product in the U.S and Europe sometime during the first half of 2024."
"Relief continues to execute on its cost effective, capital efficient approach to drug development, and the acquisition of the commercialization rights to this PKU product is no exception," stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. "This product fits perfectly into our existing line for the treatment of PKU and the distribution can be streamlined with our existing distribution platform. Our PKU GOLIKE product family has been granted Orphan Drug Designation in the U.S. and we are pursuing PKU GOLIKE(R) as a prescription product while, at the same time, focusing on commercial expansion and growth in Europe."
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 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 phenylalanine free-amino acid-mix to prevent protein deficiency and optimize metabolic control.
ABOUT RELIEF
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 drug candidate, RLF-100(TM) (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 through Relief's collaboration partner in the U.S., NeuroRx, Inc. Relief has also a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001,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. Acer's new drug application for ACER-001 was recently accepted by the FDA with a PDUFA decision date of June 5, 2022. Finally, Relief's 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 us on LinkedIn.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.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 (i) whether the acquisition of commercialization right for the product will be completed, (ii) whenever GOLIKE (R) will ever be approved for commercialization in U.S., and (iii) 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.
SOURCE: Relief Therapeutics Holdings AG
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FAQ
What are the commercialization rights that Relief Therapeutics acquired?
When does Relief Therapeutics plan to launch the new PKU product?
What responsibilities does Relief have under the agreement with Meta Healthcare?
How does this acquisition impact Relief's existing PKU product line?
What is PKU and why is this new product significant?
