Some notes from CEO Paul Gavin's comentary during this morning's webinar
Believes that this deal with Sandoz not only provides commercial validation, but also sets the benchmark for further deals - upfront size linked to population size and similar royalty rates.
Had plenty of interest from other generic pharmas but AVE wanted a company with R & D capability and experience with the regulatory authority in Australia.
Sandoz also offers the capability to reach every pharmacy in Australia in addition to extensive global reach, with a portfolio of 1,500+ approved medicines sold in 100+ countries.
Paul spelt it out for all the doubters and knockers .... The US$3m upfront is payable on signing, that is, the upfront is DUE NOW!!!! and there is NO CLAWCACK CONDITION!!!
Confirmed that the upfront will see AVE through to the interim analysis.
Milestone details remain confidential other than that US$16m is payable in two tranches prior to commercialization.
AVE will manufacture the product in the US and then sell the product to Sandoz.
Focus will now be on getting to interim analysis as fast as possible. Following this deal, new sites can now open. Also, tweaking of exclusion criteria is expected to boost enrolment rates. For example, of 1,000 expressions of interest following media coverage of the trial, 200 potential recruits were excluded because they sometimes nap. These people will now be invited to reapply.
Hope to enrol the 219 patients required for interim analysis before the end of the year.
If interim analysis data is very good, there is the possibility to finish the trial at that point and submit for approval with the assistance of Sandoz.
Comment that AVE can now go back to partnering discussions for other products, with potential partners aware that Sandoz has done extensive due diligence on AVE prior to entering this deal.
Comment that AVE is “right now” in licensing discussions for “legacy products”.
Interest has already been expressed for the TPM/CBD product in other territories, with EU of particular interest.
Asked what the plans were for revenue generated by successful approval, Paul had a long wishlist that included further development of cannabinoid products in other indications and routes of administration as well as further work on legacy products.
Said that Sandoz completed extensive due diligence that involved 15 people examining everything (data, personnel, CVs of all service providers, GcP compliance, IP etc) with a fine tooth comb over a 2-3 month period.
Insomnia is seen as a “gateway to mental health” – improving sleep can improve anxiety and depression but practitioners are reluctant to prescribe current pharmaceuticals for sleep because of the risk of self-harm.
In Australia and New Zealand the TPM/CBD product is allowable for sale as an OTC product; currently, it would be sold as a prescription product elsewhere.
Has no doubt that, if approved, the OTC product will be accessed by those wishing to use it for other indications.
Paul was deservedly very happy and very proud of this deal which he said had taken so much work.
Asked about the possibility of acquisition in the future, the answer was “Definitely…”.
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(20min delay)