Pharma Focus Europe

Relief Signs a Definitive Agreement to Acquire a Novel Dosage Form of an Already Approved Prescription Drug for the Treatment of PKU

Thursday, July 14, 2022

Relief Therapeutics Holding SA, 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.”

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