Last year, Swiss biotech Santhera Pharmaceuticals claimed a Phase IIb win for vamorolone for Duchenne — just a few months after axing its previous Duchenne candidate after a Phase III fail and trimming staff.
Now, with the biotech hoping for FDA approval sometime next year, Santhera turned its attention to its finances — and some renegotiating later, it’s opened up some liquidity to hopefully last the company until next year.
Months after axing a Duchenne program and laying off dozens, Santhera claims a win there with a different program
Santhera had been working on vamorolone, an investigational drug that was originally developed by private biotech ReveraGen as a dissociative steroid, CEO Dario Eklund tells Endpoints News. The biotech noted that if FDA approval is achieved, it would have triggered a $50 million dollar milestone payment to ReveraGen. Instead, the deal has been modified — Santhera only has to pay $26 million upon FDA approval (plus $4 million in the meantime before approval), but Santhera has to increase its sales milestone payment by $20 million. That payment is only due if vamorolone’s annual revenue reaches $100 million.
Eklund added that the drug candidate has fast track designation from the FDA — and that a rolling review has already started with preclinical data and CMC information already submitted. What’s left on the submission, according to Eklund, is the clinical data, which the CEO says should be completely submitted by the end of June. Then, it’s a waiting game for the FDA to finalize that it received everything by the end of August or early September, according to Eklund, and then waiting for the federal regulatory agency to issue a PDUFA date within Q1 or Q2 next year.
“We will then find out from the FDA whether they accept the filing. And if they do, they will provide us with a PDUFA date. And the PDUFA date could be either a priority review, which we will apply for — a pediatric priority review — which would mean a six-month review,” Eklund added. If that request gets approved, it could mean a PDUFA date in Q1 next year. If not, that date will end up somewhere in Q2.
Shares of SANN on the Swiss stock exchange slid down between 6 and 7% after the announcement was made early Thursday.
After finishing the FDA submission, the next plan for Santhera is to also file with the EMA — which Eklund said should be done in Q3 this year.
In the meantime, Santhera also acquired an option for upsized financing from investment firm Highbridge — for over $41 million to meet liquidity requirements through Q1 2023. Santhera CFO Andrew Smith told Endpoints that the biotech is not mandated to pull that financing if it can find other sources of investment, such as private placements, public equity and royalties.
“Bottom line is, this provides contingency level through to approval. Before this, we previously signaled around $100 million or so to break even, which included a $50 million approval milestone, and sort of 50 operational. So this is 60 out of that total. So it’s a big chunk, and it’s almost as much as our current market cap,” Smith said. The CFO added, “We’re not mandated to pull that facility. We can use that facility if we choose. It’s relatively expensive money, so we’re going to continue looking in the near term for other alternatives.”
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