Myovant's uterine fibroid drug looks competitive in PhIII — but can they vanquish mighty AbbVie?
Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.
Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.
In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.
The success here, though, has to be compared with AbbVie’s elagolix, approved last year for endometriosis and also on track for a date with the FDA on uterine fibrosis — a condition that causes heavy menstrual bleeding among a portion of the patients who have fibroids. AbbVie’s Phase IIIs produced clinical improvements for 76% and 68.5% of patients.
A couple of months ago, researchers provided an outline of elagolix side effects, though, that gave experts in the field caution about just how widely sought after the drug may be. In addition to the loss of bone density, the side effects also included a profile similar to menopause, with hot flashes and night sweat. That could persuade all but the most serious cases to avoid the gonadotropin-releasing hormone (GnRH) antagonist.
“Women are willing to put up with [fibroids] for years, so the idea of taking a medication that will have significant side effects I don’t think is often that popular. [Symptoms] are not as dramatic as the debilitating pain from endometriosis,” Charles Ascher-Walsh of Icahn School of Medicine at Mount Sinai told MedPage Today.
Myovant, meanwhile, said that there were no significant differences in terms of bone mineral density with a similar effect in terms of hot flashes — 5.6% for the drug versus 3.9% for the placebo.
Cowen’s Phil Nadeau sized it up and likes Myovant’s chances of carving out a blockbuster franchise:
We think that today’s data from LIBERTY 2 corroborates the LIBERTY 1 results and confirms that relugolix+add-back therapy has a competitive profile with similar efficacy, somewhat better tolerability, and improved convenience compared to AbbVie’s Orilissa. Therefore we continue to believe that relugolix has $1B+ sales potential in uterine fiborids.
Drawing distinctions between the two could be tough in this market for a company that doesn’t have near the same kind of commercial punch as AbbVie. But Myovant has a competitive profile. Investors bid their shares up 10% this morning in something less than an enthusiastic embrace for the rivalry ahead — then saw that melt away to a 1% drop in the early afternoon.
Social image: Vivek Ramaswamy at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube