Mr. Fabio Chianelli reports

PHARMATHER ANNOUNCES FDA ACCEPTANCE, AS A PRIORITY ORIGINAL ABBREVIATED NEW DRUG APPLICATION, FOR KETARX(TM) (KETAMINE)

The United States Food and Drug Administration (FDA) has accepted Pharmather Holdings Ltd.'s abbreviated new drug application (ANDA) for Ketarx (racemic ketamine). The FDA assigned a generic drug user fee amendments of 2022 (GDUFA) goal date for this priority original ANDA of April 29, 2024. The company anticipates the commercial launch of Ketarx in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.

"The acceptance of the ANDA for ketamine is a significant milestone for Pharmather that brings us one step closer to becoming a global leader in ketamine for unmet medical needs," said Fabio Chianelli, chief executive officer of Pharmather. "Ketamine has been on the FDA's drug shortage list for over five years, and its potential for mental health, neurological and pain disorders continues to gain momentum and validation through published clinical research and real-world use cases."

Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) listed on the WHO essential medicines list. Ketamine has been on the FDA's drug shortage list since February, 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February, 2023, and Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings.

Outside of the FDA- and Health Canada-approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders. A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

Pharmather's priority is to commercialize Ketarx in the U.S. through its recently announced partnership with Vitruvias Therapeutics Inc., a leading U.S.-based specialty generic pharmaceutical company. The company expects to market various dosage forms of Ketarx, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

About Pharmather Holdings Ltd.

Pharmather Holdings develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The company's lead product is Ketarx (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications.

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