Relief Therapeutics agrees to acquire a novel dosage form of an already approved prescription drug for the treatment of PKU
- Relief Therapeutics Holding (OTCQB:RLFTF) said Wednesday that its wholly owned subsidiary, APR Applied Pharma Research SA in pact with Meta Healthcare, has acquired 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 intended for the treatment of patients with phenylketonuria.
- The improved product is expected to improve patient acceptance and compliance.
- Financial terms of the deal are not disclosed.
- Per the terms, Meta will provide the technology transfer package and Relief will conduct clinical studies, manufacturing, regulatory submission and commercialization in the U.S. and EU.
- "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," said Raghuram (Ram) Selvaraju, Chairman of the Board of Relief.
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Comments (1)
From the real PR:"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 FDA......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....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."WTF? Why do you need to file an IND and run clinical trials for a drug "already approved" by the FDA? They only had $49M as of 3/31/22 - they must not have paid much for this drug.