Psychedelics biotech PharmaTher Holdings (OTCQB:PHRRF) has entered into a collaborative partnership with pharma marketing company Vitruvias Therapeutics for the commercialization of its proprietary racemic ketamine products, KETARX, in the U.S. market.
The collaboration contemplates a definitive agreement having PharmaTher as responsible for KETARX's regulatory, manufacturing and supply, while Vitruvias would work on marketing, sales and distribution to hospitals, institutional and clinical channels.
The products will be available under ketamine's FDA-approved label, coming in various dosage forms (10, 50 and 100 mg/ml) and with the option of increasing concentration and ready-to-administer applications.
Beyond the federal agency's approved indications, the compound is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain.
See also: PharmaTher Seeks Regulatory Approval Of New Ketamine Delivery System For Anesthesia And Sedation
PharmaTher's CEO Fabio Chianelli says the company's "highest priority" is obtaining regulatory approvals as well as commercializing KETARX "worldwide" for unmet medical needs.
See also: Ketamine Company Advances Parkinson's Treatment Through Final Stages Toward FDA Approval
"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," Chianelli further stated.
On behalf of Vitruvias, CEO Carl L. Whatley Jr. added that ketamine's "evolving adoption" for its current FDA-approved use and other potential indications mark a growth opportunity in the U.S. market, which the company would leverage through its "strong commercial expertise and infrastructure."
PharmaTher expects to file its Abbreviated New Drug Application (ANDA) for KETARX with the FDA in early July and obtain the agency's approval in the first quarter of 2024.
Anticipating KETARX's commercial launch in next year's second quarter, the partners will work on pre-launch activities including marketing, pricing, distribution, managed care, trade relations and sales plans.
Photo: Benzinga edit with photo by Pexels.