The Japanese biotech company behind the newly approved Alzheimer's drug Leqembi isn't running a victory lap just yet.
"What this disease state has needed for a long time has been a catalyst," Alex Scott, executive vice president of integrity at Eisai, said in an interview with Yahoo Finance.
"This is very much a catalyst," Scott said of Leqembi.
The drug received full approval this month, opening the doors to Medicare payments and expanding access for Alzheimer's patients who qualify for the twice-monthly infusion treatment.
Leqembi showed it was able to reduce cognitive decline by 27% in patients after 18 months or slow down the progress of the disease by about five months. But the label for the drug includes a warning that patients should be screened before use to avoid serious side effects if they are at high risk.
Eisai has until the end of the year to enjoy its status in the market. Competitor Eli Lilly (LLY) announced Monday that its treatment, donanemab, showed a 35% reduction in cognitive decline, or about seven-and-a-half months of slowing disease progression.
Both Eisai's and Lilly's drugs target the reduction of what is known as beta-amyloid plaques, which build up in the brain, disrupt cell function, and contribute to Alzheimer's disease.
Lilly also boasted up to a 60% slowdown in cognitive decline for its earliest-stage patients.
Eisai is focused on expanding access for Leqembi to earlier-stage patients, by providing different dosing levels and through an injectable form, which would help reduce the burden on patients to travel to clinics or to coordinate home infusions.
"We're expecting that Leqembi is also going to work in even earlier stage patients than where we are," Scott said.
"That's a longer treatment time frame and will be placebo-controlled, so we may get a different view of longer-term efficacy."
Setting up for the future
Eisai's road to approval was a journey that in part was overshadowed by the predecessor drug developed with the same partner, Biogen. Aduhelm notoriously hit the market with a high price tag amid concerns about whether or not it was rushed to approval.
But that didn't deter Eisai.
"Everything in our industry is built on failure. At Eisai, we have a rich history of programs that have failed — gamma secretase, beta secretase — the development of Leqembi is a long story with all sorts of twists and turns. So, failure is an important part of success," Scott said.
In fact, the lessons learned from Aduhelm's failure helped Eisai navigate the process. That includes knowing that Medicare would place restrictions on anything but a full, traditional approval.
"We'd never interacted with CMS before. And we came to the table, we met with them many times over 18 months. And we basically said look, we're a new company to this, we respect your authority, and we're not here to debate your mandate. We are here to educate you around our program, around our results," Scott said.
It's why the company chose the price point it did and filed for full approval in order to get more potential patients on its drug.
Scott said Eisai still expects its forecast of 10,000 patients by March 2024 and 100,000 patients by March 2027 to pan out.
"Given what happened with aducanamab (Aduhelm), we wanted to be overly explanatory. From our perspective, price will always be something that someone will comment on. We feel like....we took it off the table. We don't get a lot of discussion on price," Scott said.
In fact, the company believes it has set the bar for other competitors to follow on both price and data transparency, he said.
Follow Anjalee Khemlani on Twitter @AnjKhem