India Pharma Outlook Team | Friday, 07 October 2022
Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company, announced that it has hired a leading national health services company to serve as exclusive distributor of PKU Golike in the US. 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 US 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.”
PKU Golike is a phenylalanine-free food intended for special medical purposes (FSMP) in the US. 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. 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. 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.
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