Downtrodden Teva Wednesday got some good news—and Neurocrine got some company.
The FDA approved the Israeli drugmaker’s Austedo to treat movement disorder tardive dyskinesia (TD) in adults, marking the med’s second approval. It won its first go-ahead in early April as a therapy for another movement disorder, chorea, which is associated with Huntington’s disease.
Now, Austedo will join Neurocrine’s Ingrezza in the TD department, where Ingrezza has been since nabbing the agency’s favor in mid-April. Its field force of about 160 got the launch rolling not long thereafter.
And while Neurocrine knew Teva was hot on its tracks, CEO Kevin Gorman said in an interview at the time that the company wasn’t worried—in part, because Teva’s med requires a titration process, with patients starting on a low dose and working their way up “slowly and carefully,” as he put it.
Ingrezza, on the other hand, is a fixed-dose product, with patients receiving either 40 mg or 80 mg. Ingrezza is also dosed once-daily, compared with twice-daily Austedo—a factor that could hurt adherence to the Teva med in a population that Gorman called “highly noncompliant.”
Teva’s chief scientific officer Michael Hayden, though, praised Austedo’s dosing regimen, saying in a statement that he believes “physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”
Analysts, meanwhile, disagree on Austedo’s sales potential; RBC Capital Markets’ Randall Stanicky has said he expects to see the product rake in peak sales of $1.33 billion in 2022 across all its indications. Wall Street consensus sits at $700 million, while Wells Fargo’s David Maris has predicted a 2017 mark of less than $100 million that’ll swell to close to $1 billion by 2022.
Teva will take whatever revenue help it can get, though. The embattled drugmaker earlier this month lopped more than $1 billion of its 2017 sales forecast for the second time this year, also announcing thousands of layoffs and a big cut to its dividend.
Still, while the approval is positive, "it was largely expected and we believe not enough to reverse the recent pressure in the stock as the company continues to face meaningful headwinds," Stanicky wrote to clients Wednesday.