Despite a months-long delay, Evolus has overcome manufacturing faults FDA previously found and managed to secure a nod to begin marketing its Botox rival. And you can count on Allergan to mount a legal counterattack to block the US entry of a biologic that can threaten its $3.5 billion franchise.
The approval came just after market close on Friday for Jeuveau, a 900 kDa purified botulinum toxin type A formulation that reduces frown lines — or “glabellar lines associated with corrugator and/or procerus muscle activity in adults” if you prefer the academic term.
In a head-to-head Phase III trial involving 540 Europeans and Canadians, investigators reported responder rates of 87.2% in the group receiving Evolus’s drug, 82.8% in the Botox group, and 4.2% in the placebo group. Other Phase III trials conducted in the US established superiority over placebo, the company says.
Perhaps more pertinent to its plan to disrupt a market currently dominated by Botox, Evolus “anticipates a 20-25% discount to market leader,” a company representative tells Endpoints News in an email, with more details to come.
In a trade complaint filed two days before the approval, though, Allergan claims that the rival wrinkle therapy piggybacks on R&D secrets stolen by a former staff scientist at its partner Medytox.
The employee then allegedly handed the “meticulous, time-consuming, and expensive research” on how to convert the deadly botulinum toxin into a treatment to Daewoong, which later out-licensed its drug, DWP-450, to Evolus, according to a Bloomberg report of the filing. Daewoong already markets the product in South Korea as Nabota.
The complaint, filed at the US International Trade Commission in Washington, follows 2017 complaints in Korea that Medytox filed against Daewoong. The cases are ongoing.
Even if Allergan gets its way this time — which is highly uncertain — rival offerings from Revance Therapeutics and Hugel will still be fast on its heels.
And if it doesn’t, Evolus believes that it can move into the number 2 share position within a few years, Leerink’s Marc Goodman notes, given an EU approval expected in mid-2019 and launch in Canada before that.
Whether achieving the number 2 position happens or not, we do believe that investors should expect a noticeable impact to the Botox Cosmetic growth rate from new competition. We model US market growth of ~9% with Botox sales growth of ~6% in 2019E and market growth of ~8% and Botox sales growth of ~5.5% in 2020E. Given that Botox is the most important asset for Allergan, we would also expect significant investor attention focused on this share dynamic and some extra volatility in the stock, just as we saw during previous Botox competitor launches.
Having denied allegations against them, Evolus and Daewoong are already at work building out a specialty sales team — which Evolus envisioned (when it went public) to consist of 65 reps at launch this spring and grow to 150 over time.
Evolus CEO David Moatazedi — ex-aesthetics chief at Allergan — has this to say in his toast to the news:
Evolus is the first company in nearly a decade to enter the fast-growing US aesthetic neurotoxin market […] The launch of Jeuveau will be powered by our technology platform designed to eliminate the friction points that exist for customers today.
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