Postpartum depression (PPD), a so-far untapped market, is large enough for multiple players with 1 in 7 women diagnosed with the condition that has no specific therapies approved by the FDA. But Sage $SAGE, which reported impressive late-stage data on its pill in severe PPD patients on Monday, is not worried about potential competition.
Analysts have drawn cautious comparisons with Marinus $MRNS, whose drug ganaxolone is also under evaluation for PPD. An IV formulation of ganaxolone is currently in a Phase II study in severe PPD patients, while mid-stage data from an oral formulation of ganaxolone in moderate PPD patients is expected in the first half of this year.
Sage, meanwhile, is clearly ahead. The FDA is expected to make a decision on the approvability of its IV PPD drug, brexanolone, by March 19, after a setback delayed the decision by three months. The company’s oral PPD drug — SAGE-217 — reported stellar Phase III data on Monday, and Sage intends to wait for data from a pivotal study on the pill in patients with major depressive disorder (expected in 2020) — before it submits a marketing application. The oral drug has secured the agency’s breakthrough therapy designation.
“I think we’re in two very different worlds, both scientifically at this point and strategically as well,” Sage chief medical officer Steve Kanes said in an interview with Endpoints News, when asked about the Marinus compound.
But Cantor Fitzgerald analysts predict the two companies may end up with equal market share considering the size of the largely untapped market — if both manage to take their respective drugs across the finish line.
“We model ~572,000 women per year in the U.S. are affected with PPD and believe both Sage and Marinus (we model 30% peak market penetration) could have fair market share versus existing therapies that take too long to work and are not efficacious for a majority of patients,” they wrote in a note.
Sage declined to provide detail on their expected timeline toward approval for SAGE-217 and suggested it was too early to talk about pricing.
When asked about whether the company would be open to takeover discussions, Kanes reiterated their plan was always to grow and develop and independent company — from discovery all the way to commercialization.
“The kinds of opportunities we look for are ones that accelerate treatment for patients — a good example of that is our partnership Shinogi in Japan,” Kanes said.
Japan’s Shionogi last June agreed to an up $575 million deal to bag limited Asian rights to the SAGE-2017 — with $90 million in as cash upfront, a day after the Cambridge, Massachusetts-based company secured breakthrough therapy status from the regulator.
But when pressed on whether a takeover was off the table, Kanes did not directly comment, electing instead to say that operating as an independent entity has always been their position.
Sage’s SAGE-217 results on Monday morning catapulted the stock up about 44% to $140.66 in midday trading.
“We had thought that a positive study would fundamentally add in the $15-20 range. However, that forecast was way off given the $50-55 positive move this morning, much of which we would attribute to excitement regarding M&A in the biotech space, and since SAGE has been viewed as a potential take out candidate,” Leerink analysts wrote in a note.
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