Clearly Sandoz have seen something that they like in the Avecho offering in which the difference in cost between the various components of the approved product are insignificant in relation to the revenue benefits of a successfully approved product and its potential market size.Kens
Sandoz, along with other global generics companies, was well aware of the unique opportunity for low-dose OTC CBD which was created by the TGA in 2020. Paul Gavin has stated that not all global generic pharma have been interested in this OTC CBD opportunity as the Australian market isn’t a priority for them, but some have been, and that includes Sandoz.
As stated in the licensing webinar presentation of 4 March, Sandoz is very familiar with the Australian market – it is the second largest generics and biosimilars company here; it has a nationwide presence and strong partnerships with all the major pharmacy chains; it has a large, dedicated OTC team and it has a distribution network capable of reaching every pharmacy in Australia.
So Sandoz is well-placed in Australia and could see the potential value of offering a non-prescription, approved pharmaceutical CBD product.
As for what Avecho was offering that has attracted Sandoz, I think that Paul Gavin’s recent interview with David Traylor from Golden Eagle Partners provides insight.
At heart, it seems to be the approach that Avecho has taken, applying its drug development experience to developing a pharmaceutical-grade CBD product. While there have been multiple cannabis-specialist companies in Australia that have sought to exploit the OTC CBD opportunity, Avecho is different in that it is a dedicated drug development company using its knowledge and experience to develop a pharmaceutical-grade drug product that happens to be CBD. One could say that Sandoz and Avecho “speak the same language.”
Based on the Golden Eagles Partner interview, the following features would seem to be what has attracted Sandoz to Avecho’s offering:
- Avecho’s product is a patient-friendly, GMP-compliant, softgel capsule. Pharma doesn’t want oils.
- Cannabidiol is a highly unstable molecule but pharma wants a stable product with suitable shelf life. Avecho’s formulation has now passed the 3 year stability mark.
- Patent protection – CBD API isn’t patent protected but Avecho’s product is backed with patent protection up to 2040.
- Strong data - Avecho has strong data from Phase 1 and preclinical in-vitro and in-vivo testing, including an independently-conducted head-to-head trial with Epidiolex which was completed in the same lab used by GW Pharma in its development of Epidiolex.
- CBD has poor oral bioavailability. Avecho’s product has significantly enhanced bioavailability due to its formulation with TPM.
- Avecho’s product works in both fed and fasted state.
- Avecho’s product is being tested in a rigorous Phase 3 trial design, which includes a larger number of participants for statistical power, use of the maximum allowable dose, an extended dosing period, strict exclusion criteria and strategies to minimise placebo effect.
- The drug development program for this product has been designed to satisfy not only TGA requirements but also potentially satisfy the requirements of overseas regulatory authorities, including the FDA.
- Potential first-mover advantage – Avecho currently leads the race in Australia to develop a TGA-approved OTC CBD product.
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