What about the newest products on the US market?
In June, we obtained marketing authorisations for Rilexine chewable antibiotic tablets for dogs and Suprelorin F, the deslorelin acetate-based contraceptive implant for ferrets. Both registrations have involved a long drawn-out process in terms of development, well executed by the product development teams. While Rilexine was the subject of a standard procedure with the FDA, Suprelorin F is Virbac’s first product to come to market via the MUMS process.
What does that mean?
Utilizing the MUMS process (minor use, minor species), a regulated product targeting either a minor species and/or a minor use can make its way to the market without going through the traditional development and approval pathway prescribed for veterinary products. In the case of Suprelorin F, it was added to the government’s list of legally marketed, unapproved drugs. This resulted in a savings of considerable time and expense!
Were there other advantages to this launch?
Firstly, in regulatory terms, it provided us with a unique learning experience for future uses of the MUMS process. Secondly, in terms of marketing, with the launch of Suprelorin F, we expect to learn how to quickly address a market we have thus far not had any contact with. Bringing the Suprelorin F implant to the US market will also bring for the first time in the US the benefits of a medical solution to a problem of managing a potentially life-threatening condition in ferrets.
And what about Rilexine?
In the US, there is a definite advantage to being the first FDA approved cephalexin flavored tablet for dogs effective in treating secondary superficial bacterial pyoderma, even if Rilexine will be going up against some established competitors. Veterinarians are very excited about offering a palatable treatment in three sizes to their clients.
What were the challenges to overcome for these registrations?
For Rilexine, while the support and cooperation from our headquarters colleagues has been fantastic, completely new safety and efficacy dossiers had to be created from scratch. Due to FDA regulations, we were not permitted to use the previously developed European data. We then had to find a compliant manufacturing facility that could be geared up with the proper procedures and provided with the appropriate equipment and know-how for tablet production, all staying within FDA regulations. Because of the nature of this antibiotic, the potential for product cross contamination as well as allergic responses, specialized manufacturing conditions are necessary. With regards to Suprelorin F, the main challenge was to take the years of technical development efforts invested by our Peptech/Virbac Australia colleagues and present that dossier in a way that complied with the MUMS indexing process, including expert reports regarding safety and efficacy from three non-Virbac experts.
In addition to these two highlyanticipated launches, Virbac US has an amazing portfolio of R&D products. As part of Virbac’s transnational innovation concept, we gained this year approval of three products, including Easotic, and our plans for the future include continuing to maintain our innovative and strategic approaches in product choice and marketing.