Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024
TORONTO, June 20, 2023 -- 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.
Carl L. Whatley, Jr., CEO of Vitruvias, commented: “We are excited about the opportunity to add KETARX™ to our already robust commercial generic product portfolio for the U.S. market. The evolving adoption of ketamine for its current FDA approved use, and potentially other indications excite us on the opportunity to grow the market for ketamine in the U.S., leveraging our strong commercial expertise and infrastructure.”
The collaboration contemplates a definitive agreement whereby PharmaTher would be responsible for regulatory, manufacturing and supply of KETARX™, and Vitruvias would be responsible for the marketing, sales, and distribution to hospitals, institutional and clinics channels in the U.S. market.
About Vitruvias Therapeutics Inc.
Founded in 2013, Vitruvias Therapeutics Inc. is an experienced specialty pharmaceutical company focused on the marketing & distribution of prescription products within the United States and Puerto Rico. Vitruvias is especially active with non-U.S. based generic drug developers and manufacturers who are seeking distribution channels within the U.S. and leverages its expertise in all aspects of the pharmaceutical industry, including product development, licensing, regulatory affairs, marketing, financial analysis, distribution, managed care, trade relations and sales. Visit Vitruvias.com.
About PharmaTher Holdings Ltd.
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. Learn more at PharmaTher.com.
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PharmaTher Holdings Ltd.
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