Amid the brouhaha over Alnylam’s disappointing and perhaps confusing HELIOS-B data presentation last week, competitor BridgeBio is — at least publicly — attempting to stay above the fray and stick to its commercialization plans.
In an interview, BridgeBio CEO Neil Kumar declined to directly compare acoramidis against Alnylam’s vutrisiran, which are both attempting to win approval in transthyretin amyloid cardiomyopathy (ATTR-CM).
The competition, closely followed for years, heated up at the European Society of Cardiology’s annual meeting after Alnylam’s presentation led to a dispute between the company and the presenting researcher over a “typo” on a slide discussing all-cause mortality rates. Alnylam’s stock $ALNY is down 12% and BridgeBio’s shares $BBIO are up 27% since the presentation on Aug. 30.
At the Morgan Stanley Healthcare Conference in New York on Wednesday, Kumar said acoramidis’ 42% relative risk reduction at 30 months “compares very favorably” to Alnylam’s data. Asked by Endpoints News on Thursday how he feels about acoramidis and its data in the wake of the ESC meeting, Kumar instead pointed to the importance of having multiple drugs available for patients.
“I’m confident that our data is going to be important for patients and physicians, and I would leave it up to the physicians and everyone else in the community to make the right decision about the right drug for patients,” Kumar said. “No single medicine in this space, including ours, has a 100% response rate.”
An Alnylam spokesperson on Thursday reiterated that the presentation was incorrect and said it had been updated. Mizuho analyst Salim Syed told Endpoints that the only difference in the new slides was the removal of the 30-month all-cause mortality figures at the center of the dispute, noting that the calculations hadn’t changed.
Acoramidis is expected to face an FDA decision by Nov. 29, while vutrisiran is expected to be submitted for approval in ATTR-CM later this year. Alnylam has said it intends to use a priority review voucher, shortening the review time by about six months.
The time will give BridgeBio a “second-mover” advantage in the space, Kumar said, alluding to Pfizer’s already-approved tafamidis, which is marketed as Vyndaqel and Vyndamax. He noted that Pfizer has done much of the legwork establishing the market, and BridgeBio’s acoramidis will be on the market before vutrisiran.
“We’ve seen what Pfizer has done, and they’ve done an incredible job of finding patients, growing the market,” Kumar said. “Beyond that, the checklist that comes really from the incumbent, you say, ‘OK. What else can we do to serve this community in a different way?’”
If approved, acoramidis will be BridgeBio’s biggest launch to date, but Kumar played down any potential commercial hiccups. He said that BridgeBio won’t be doing much different than it did for its first two products — Nulibry for a rare genetic disorder, and Truseltiq for bile duct cancer — other than having a larger sales force and medical affairs team. Both patient populations for those drugs are significantly smaller than ATTR-CM.
Much of the work Kumar expects BridgeBio to do is to address the underdiagnosis of ATTR-CM patients. Right now there are about 47,000 patients in the US who have received an ATTR-CM diagnosis, but BridgeBio — as well as Alnylam and analysts — estimate the full population to be somewhere between 250,000 and 300,000 people.
If everything goes according to plan, Kumar said BridgeBio could eventually capture between 25% to 40% of the market. He also didn’t rule out Phase 4 studies that could include head-to-head comparisons against tafamidis and vutrisiran.
“As a second mover, we don’t think we’re going to take a majority of the market,” Kumar said.