The collaboration aims to facilitate the commercialisation of PharmaTher's Ketarx (racemic ketamine) products in the US
PharmaTher, Vitruvias partner to commercialise Ketarx in US. (Credit: Arek Socha from Pixabay)
PharmaTher Holdings, a specialised pharmaceutical company with a focus on commercialisation, has formed a collaboration agreement with Vitruvias Therapeutics, a US-based company specialising in generic pharmaceuticals.
The collaboration aims to facilitate the commercialisation of PharmaTher’s Ketarx (racemic ketamine) products in the US.
Through the partnership with Vitruvias, Ketarx will be marketed in compliance with the FDA-approved label for ketamine, available in various dosage forms such as 10 mg/ml, 50 mg/ml, and 100 mg/ml.
Additionally, there will be the option to increase the concentration of the product and develop ready-to-administer applications specifically tailored for the US market.
It’s worth noting that ketamine is currently listed on the FDA’s drug shortage list. Apart from its approved indications, ketamine is also being used in hospitals and clinics to treat a range of disorders related to mental health, neurological conditions, and pain management.
PharmaTher plans to submit an abbreviated new drug application (“ANDA”) for Ketarx (racemic ketamine) to the FDA in early July, with the expectation of obtaining FDA approval by the first quarter of 2024. In preparation for a potential commercial launch of Ketarx in the second quarter of 2024, PharmaTher and Vitruvias will collaborate on various pre-commercial launch activities. These activities will include marketing strategies, pricing considerations, distribution channels, managed care approaches, trade relations, and sales plans.
PharmaTher CEO Fabio Chianelli said: “Our highest priority is to obtain regulatory approvals and commercialise Ketarx (racemic ketamine) worldwide for unmet medical needs.
“We are focused on building a network of strong commercial partnerships with leading speciality 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.”
Vitruvias, established in 2013, is a well-established speciality pharmaceutical company specialising in the marketing and distribution of prescription products in the United States and Puerto Rico. Under the leadership of Carl L. Whatley, Jr., a seasoned professional with 40 years of experience in sales and marketing within the speciality generic pharmaceutical industry, Vitruvias has garnered extensive expertise in its field. Additionally, the board members of Vitruvias hold executive positions with notable organisations such as Perceptive Advisors and JW Asset Management.
Vitruvias CEO Carl L. Whatley, Jr. said: “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.”
The collaboration between PharmaTher and Vitruvias involves a comprehensive agreement that outlines their respective responsibilities. As per the agreement, PharmaTher will assume the tasks related to regulatory compliance, manufacturing, and the overall supply of KETARX. On the other hand, Vitruvias will take charge of marketing initiatives, sales activities, and the distribution of Ketarx to hospitals, institutions, and clinics throughout the US market. This division of responsibilities allows both companies to leverage their expertise and resources effectively, ensuring a coordinated and efficient approach to bring Ketarx to the target channels and customer base.