Four months after the FDA rejected Teva’s “breakthrough” drug SD-809 for treating chorea associated Huntington’s disease, the pharma group is back with a batch of mixed Phase III data on tardive dyskinesia, the involuntary movements associated with the degenerative disease. And once again Teva is upbeat about the results, saying the data clears the way to a new marketing pitch later this year.
A year-and-a-half ago Teva $TEVA splurged on a $3.5 billion acquisition of Auspex, bagging the new and what it hoped was an improved drug for Huntington’s. Now it’s saying that its second late-stage study shows that the drug is clearly a success, but there are still some significant problems to address.
Investigators say that a high and mid-range dose of their drug hit the primary endpoint on the movement scale rating for a “modified intent to treat” group. The low dose failed to separate significantly from the placebo. But the high dose, meanwhile, missed beating the placebo based on investigators’ assessment of how their patients were doing.
Neurocrine execs noted in their Q2 call with analysts at the end of August that they are already building a marketing group for the drug, which has also achieved a breakthrough drug designation that could put it on track to an approval as early as next spring. The drug is a VMAT2 inhibitor, designed to modulate dopamine release during nerve communication.
Baird’s Brian Skorney compared the two drugs, and voted on Neurocrine as the likely winner in this looming showdown. Valbenazine did better at beating a placebo, with a 3.1 reduction compared to placebo versus a 1.9 difference in favor of Teva’s drug.
With at least a few months’ lead time and potential uncertainty around the metabolic profile of SD-809, we remain confident that valbenazine, now branded as Ingrezza, can garner stronger support from physicians at launch.
Jefferies’ Biren Amin agreed with Skorney on the timeline, putting Neurocrine in the lead by several months.
Teva’s drug represents a big bet for the Israeli company, which was hoping to be in the first wave of companies to get an approval for a deuterated drug, taking an existing drug — in this case tetrabenazine (Xenazine) — and redesigning it to break down more slowly, a tweak which should make it possible to provide lower dosing for maximum effect while improving the safety profile.
The FDA hasn’t required a head-to-head study against tetrabenazine, which may come back to haunt Teva if it does get a marketing approval. But it has asked for more work examining the levels of metabolites involved in breaking down the drug.
The therapy—deutetrabenazine—is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, which is designed to regulate the levels of dopamine in the brain.
A recent story in Bloomberg highlighted analysts’ projections of about a billion dollars a year in annual revenue, if Teva can make its case to patients put off by the side effects of the original drug, which include depression. More research work is being done on Tourette syndrome.
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