PharmaTher and Vitruvias sign collaboration agreement to commercialise ketamine-based treatment in the US

James Spargo | June 21, 2023 | News story | Medical Communications Ketamine, Neurology, PharmaTher, Vitruvias, commercialisation 

Specialty pharmaceutical companies, Canadian PharmaTher and US-based Vitruvias, have entered into a commercialisation partnership to bring Ketarx products to the US.

Ketarx (racemic ketamine) is ketamine’s US Food and Drug Administration (FDA)-approved label and comes in various dosage forms including 10mg/ml, 50mg/ml and 100mg/ml. It is also used outside of FDA approved indications in hospitals and clinics to treat neurological disorders, mental health issues and pain.

PharmaTher will file an abbreviated new drug application (ANDA) for Ketarx with the FDA in July 2023, with approval expected in Q1 of 2024. In preparation, PharmaTher and Virtuvias will work on pre-commercial launch activities such as marketing, pricing, distribution, managed care, trade relations and sales plans.

As part of the agreement, PharmaTher will be responsible for the regulatory, manufacturing and supply of Ketarx, and Vitruvias will be in charge of marketing, sales and distribution to institutions such as hospitals and clinics in the US market.

Fabio Chianelli, CEO of PharmaTher, commented: “Our highest priority is to obtain regulatory approvals and commercialise Ketarx 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 US market and believe Vitruvias is the ideal partner to rapidly progress our commercialisation goals in the US and unlock new commercial opportunities internationally.”

Carl L Whatley Jr, CEO of Vitruvias, added: “We are excited about the opportunity to add Ketarx to our already robust commercial generic product portfolio for the US 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 US, leveraging our strong commercial expertise and infrastructure.”

James Spargo

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