Thursday, August 31, 2023
RELIEF THERAPEUTICS Holding SA (SWX:RLF) has recently entered into an exclusive licensing agreement with Acer Therapeutics Inc. for the development and commercialization of OLPRUVA™ (sodium phenylbutyrate, ACER-001) to treat certain urea cycle disorders (UCDs) and potential other indications. This new agreement supersedes a previous collaboration between the two companies that was established in March 2021.
Jack Weinstein, CEO of Relief Therapeutics, expressed his satisfaction with the restructured collaboration with Acer Therapeutics, highlighting the benefits for both companies and, more importantly, for patients with UCDs and other rare metabolic conditions. The shared goal is to maximize the global availability of OLPRUVA™ as a much-needed and innovative treatment option.
Under the new terms, Acer Therapeutics retains the development and commercialization rights for OLPRUVA™ worldwide for UCDs and potential additional indications in the U.S. and other countries, excluding Europe. As part of the agreement, Acer Therapeutics is providing Relief Therapeutics with an upfront cash payment of $10 million, along with an additional $1.5 million cash payment on the agreement's first anniversary. Additionally, Relief Therapeutics will receive a 10 percent ongoing royalty based on net sales of OLPRUVA™ in the Acer Therapeutics territory, as well as 20 percent of any proceeds from licensing or divestment deals related to OLPRUVA™, up to an additional cumulative amount of $45 million. At the same time, Relief Therapeutics will maintain the development and commercialization rights for OLPRUVA™ in geographical Europe.
Chris Schelling, CEO of Acer Therapeutics, emphasized that Relief Therapeutics remains an ideal partner for OLPRUVA™ in Europe and expressed eagerness to continue advancing the treatment for rare metabolic disorders like UCDs.
This agreement marks a strategic shift for Relief Therapeutics, moving from a profit-based model to a revenue-based royalty structure. This change is expected to provide Relief Therapeutics with earlier returns, decrease certain associated risks, and increase the predictability of royalty income. The arrangement will also support Relief Therapeutics' ongoing operations, extend its financial resources, and enable investments in its pipeline, including efforts to seek approval to commercialize OLPRUVA™ in Europe.
It's noteworthy that the U.S. FDA granted approval for ACER-001 (sodium phenylbutyrate) in December 2022 to treat certain UCDs, and the treatment is now available in the U.S. under the name OLPRUVA™. Additionally, OLPRUVA™ is being investigated as a potential treatment for maple syrup urine disease (MSUD), a rare genetic metabolic disorder. It's important to review the pertinent safety information, complete prescribing details, and patient information for OLPRUVA™.
