For the uninitiated ITF Pharma is Starpharma’s licencee and ‘partner’ in the USA for VivaGel BV. They are a small privately held company and a subsidiary to Italfarmaco. Also for those unfamiliar, Starpharma has been in a legal dispute with the FDA for 5 years trying to get the NDA approved.
After intermittently monitoring the ITF Pharma website for a long time, finally they have announced some news for the
first time since 2019. They have changed their name to EDW Pharma. I’m not sure what they’ve done or achieved in the last 4 years but at least it’s something lol.
Also as a background timeline:
20 Dec 2018: Dennis Willson ITF Pharma CEO inks deal with Starpharma for VivaGel in the USA
27 Dec 2018: Starpharma advise the ASX that the FDA has refused approval for VivaGel and requires more data
Then a few days later (from the interweb):
‘Mr. Willson is the
former President & CEO of ITF Pharma, Inc., the U.S. affiliate of the family-owned pharmaceutical company, Italfarmaco. He retired at the end of 2018.’
So all that happened in the space of a 12 strange days. I’m sure the timing of his retirement/resignation was a coincidence.
I understand Peter Cook took over as CEO and President of ITF Pharma and is still in those roles. Strangely, I’ve never been able to find out anything about him or any references to him at all on the internet. Good luck trying.
Moving forward to present day, Starpharma have said recently that the partnership/deal is ‘on foot’ whatever that
actually means. Interestingly there is less than 6 years to go until the terms of the ITF Pharma and Starpharma deal/licence
expires, which incidentally (from my understanding) is when the US patent for VivaGel
expires (2030).
If the FDA ever approves VivaGel BV, it is my opinion that the licence agreement (including milestone payments etc) will have to be renegotiated. My reasoning being:
The licence was signed with ITF Pharma in late 2018 with
expected sales/revenue to start occurring in early to mid 2019 with VivaGel having primary patent protection in the USA until 2030. That would have been about
11 years of sales to ITF factored in to their US$101m licence with Starpharma.
But there has been
no approval. There have been
no sales. Therefore if FDA approval hypothetically came through in June 2023, ITF and Starpharma would only have approximately 6 years of VivaGel patent protection left,
not 11. It stands to reason the licence would likely have to be renegotiated, and IMO the licence fees and milestone payments would need to be negotiated
down significantly.
Adding to the downward pressure on the deal (strengthening ITF but weakening Starpharma’s hand) is the subsequent pathetic sales/revenue of VivaGel throughout Europe and rest of world since sales that commenced in late 2018. ITF would now be well aware of the poor sales in Europe and ROW.
ITF may have thought at the time of signing the deal they were on to a mini-blockbuster in the female health segment, however it’s probably obvious to them now that VivaGel is unlikely to ever be such a product.
First things first, there’s less than 4 weeks until the quarterly report where will will find out if Starpharma actually lodged their latest submission/appeal to the FDA in December as they
stated they would.
It’s only one of many things, but I’d like the
new CEO Cheryl Marley to give an update/clarity on the ‘partnership’ with EDW Pharma (previously ITF Pharma.)
DYOR and GLTAH
(20min delay)