Last year, Swiss biotech Santhera Pharmaceuticals scored a Phase IIb victory over vamorolone for Duchenne – just months after knocking out former candidate Duchenne after a failed Phase III and downsizing.
Now, with the biotech hoping to gain FDA approval next year, Santhera has turned its attention to its finances – and a few renegotiations later has opened up cash to hopefully last the company until ‘see you next year.
Santhera was working on vamorolone, an experimental drug originally developed by private biotech ReveraGen as a dissociative steroid, CEO Dario Eklund said. Terminal news. The biotech noted that if FDA approval were obtained, it would have triggered a $50 million milestone payment to ReveraGen. Instead, the deal was changed – Santhera only has to pay $26 million upon FDA approval (plus $4 million in the meantime before approval), but Santhera has to increase his sales milestone payment by $20 million. This payment is only due if Vamorolone’s annual revenues reach $100 million.
Eklund added that the drug candidate has received fast-track designation from the FDA — and ongoing review has already begun with preclinical data and CMC information already submitted. What remains on the submission, according to Eklund, is the clinical data, which the CEO says should be fully submitted by the end of June. Then it’s a waiting game for the FDA to finalize that it received everything in late August or early September, according to Eklund, and then wait for the federal regulatory agency to issue a PDUFA date during the first or second quarter of next year.
“We will then find out from the FDA if they accept the filing. And if they do, they will provide us with a PDUFA date. And the PDUFA date could either be a priority review, which we will ask for – a pediatric priority review – which would mean a six-month review,” Eklund added. If this request is approved, it could mean a PDUFA date in the first quarter of next year. Otherwise, this date will end up somewhere in the second quarter.
Shares of SANN on the Swiss stock exchange fell 6-7% after the announcement made early Thursday.
After completing the FDA submission, the next plan for Santhera is to also file with the EMA – which Eklund says should be done in the third quarter of this year.
In the meantime, Santhera has also acquired an increased funding option from investment firm Highbridge – for over $41 million to meet liquidity needs through the first quarter of 2023. Santhera CFO Andrew Smith , told Endpoints that biotechnology is not mandated to withdraw this funding if it can find other sources of investment, such as private placements, public shares and royalties.
“Bottom line, this provides a level of urgency until approval. Prior to this, we had previously reported approximately $100 million or so to break even, which included a 50 million approval milestone. million and kind of 50 operational. So that’s 60 out of that total. So that’s a big chunk, and that’s almost as much as our current market capitalization,” Smith said. The CFO added: “We are not mandated to remove this facility. We can use this facility if we choose. It is relatively expensive money, so we will continue to look for other alternatives in the short term.