PharmaTher and Vitruvias to Commercialize KETARX™ in the US; Shares Rise 65%
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered into a collaboration with Vitruvias Therapeutics to commercialise KETARX™ in the United States. Under terms of the agreement, PharmaTher would be responsible for pursuing regulatory approvals, and the manufacturing and supply of KETARX™.
PharmaTher expects to file its abbreviated new drug application for KETARX™ with the FDA in early July and expects to obtain FDA approval in the first quarter of 2024.
KETARX™ (racemic ketamine) has been developed to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications.
Vitruvias is a leading U.S. based specialty generic pharmaceutical company and will work with PharmaTher on pre-commercial launch activities, including marketing, pricing, distribution, managed care, trade relations and sales plans. Vitruvias would also be responsible for the marketing, sales, and distribution to hospitals, institutional and clinics channels in the US market.
Ketamine is currently on the FDA’s drug shortage list.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) 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. The Company is commercializing PharmaPatch™ (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases.