PharmaTher and Vitruvias Enter Into Collaboration Agreement for Commercialization of KETARX (racemic ketamine) in the U.S.

Expected FDA approval for KETARX (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024

TORONTO, June 20, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has entered into a collaboration agreement with Vitruvias Therapeutics, Inc. (“Vitruvias”), a leading U.S. based specialty generic pharmaceutical company, for the commercialization of the Company’s KETARX (racemic ketamine) products in the U.S.

In partnership with Vitruvias, KETARX will be marketed under ketamine’s FDA-approved label and in various dosage forms, such as 10 mg/ml, 50 mg/ml and 100 mg/ml, with the option to increase concentration and ready-to-administer applications for the U.S. market. Ketamine is currently on the FDA’s drug shortage list. Outside of the FDA approved indications, ketamine is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain.

PharmaTher expects to file its abbreviated new drug application (“ANDA”) for KETARX (racemic ketamine) with the FDA in early July and obtain FDA approval in Q1-2024. In anticipation of a potential commercial launch of KETARX in Q2-2024, PharmaTher and Vitruvias will work together on pre-commercial launch activities, including marketing, pricing, distribution, managed care, trade relations and sales plans.

Fabio Chianelli, CEO of PharmaTher, commented: “Our highest priority is to obtain regulatory approvals and commercialize KETARX (racemic ketamine) worldwide for unmet medical needs. We are focused on building a network of strong commercial partnerships with leading specialty generic companies that are experienced in the marketing, sales and distribution to the hospital, institutional and clinic channels within their territories. We are pleased to partner with Vitruvias for KETARX for the U.S. market and believe Vitruvias is the ideal partner to rapidly progress our commercialization goals in the U.S. and unlock new commercial opportunities internationally.”

Founded in 2013, Vitruvias is an experienced specialty pharmaceutical company focused on the marketing and distribution of prescription products within the United States and Puerto Rico. Vitruvias is led by Carl L. Whatley, Jr., a 40-year sales and marketing veteran in specialty generic pharmaceuticals, and its board members hold executive positions with Perceptive Advisors and JW Asset Management.