The data may be early and the patient population small, but in biotech today, who’s waiting for complete clarity?
On the day after the FDA blessed Sage Therapeutics $SAGE with its inside track on their oral depression drug SAGE-217, Japan’s Shionogi has stepped in with a $575 million deal to gather up limited Asian rights to the drug — with $90 million coming in as cash upfront.
Sage is on a roll, and they know it.
Shionogi is pledging $485 million in milestones, happy to commit that it can see its way through to an approval in Japan, Taiwan and South Korea. And that still leaves Sage — which also is pursuing an OK for post-partum depression — with rights to co-promote in Japan.
As far as terms are concerned, Sage is coming out on top for a limited set of regional rights, indicating that it has some big upside left as it maps global commercialization rights to this drug.
Shionogi is passing over the infused version of the depression drug, preferring a much easier to use oral version that promises to disrupt the entire industry.
According to Sage $SAGE execs, regulators are demanding only one more late-stage study, which will now get underway in a matter of months. Sage plans to evaluate “two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in 450 patients with MDD, with four weeks of additional follow-up.”
The agency is signing off on a plan that offers a dramatic shift from the usual long and drawn out late-stage testing of depression drugs in big, multiple studies — making it one of the most difficult fields in R&D plagued by high placebo responses. The biotech is going after a new mechanism — extra-synaptic GABA-modulation — while the current generation of drugs share common neurotransmitter targets like serotonin, dopamine and norepinephrine.
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