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Eisai predicts sharp Leqembi sales increase as launch efforts begin to bear fruit

Reflecting on Eisai’s Alzheimer’s disease development journey—from Aricept’s U.S. launch in 1997 to Leqembi nearly a quarter century later—the company’s CEO Haruo Naito on Wednesday offered these words from Japanese poet Takamura Kotaro’s famous work Dōtei: “There is no way before us, but there will be a way after us.”

Naito waxed poetic as Eisai laid out an ambitious goal to hit 56.5 billion yen (roughly $364 million) in global Leqembi sales for the 2024 fiscal year, which will wrap up next March.

That target represents a nearly 13-fold increase from the med’s sales of 4.26 billion yen (around $27.4 million) during the 2023 fiscal year.

In an earnings release (PDF), Eisai banked its estimate on the fact that the company and its partner Biogen have steadily improved Alzheimer’s disease diagnosis and treatment pathways in the U.S. and Japan—and expanded the antibody’s reach to other countries like China, too.

Of that projected sales haul, Eisai expects to garner around 43.5 billion yen ($279 million) from the U.S., 10 billion yen ($64 million) from Japan and 3 billion yen ($19 million) from the rest of the world, mainly in China, Naito said, according to a translation of Eisai’s Japanese-language earnings call.

Leqembi—the amyloid-targeting antibody successor to Eisai and Biogen’s Aduhelm—won accelerated approval in the U.S. last January. The partners converted that nod into a full, traditional FDA approval in July, in turn unlocking broader Medicare coverage for the drug.

Though Leqembi’s launch sputtered out of the gate thanks to factors ranging from reimbursement delays to diagnostic and treatment logistics, the drug has been picking up the pace in recent months. The med’s sales more than doubled between the third and fourth quarters of the Japanese fiscal calendar.

In the U.S. specifically, where most of Leqembi’s sales are recorded, Naito pointed out that the drug’s launch has entered its “prescription expansion phase” following last year’s focus on infrastructure build-out.

The CEO’s comments echo those of Eisai’s former U.S. helmsman Ivan Cheung, who told Fierce last year that following Leqembi’s accelerated nod, the company’s main goal was “getting ready for the full launch” by prepping hospital systems, confirmatory diagnostic testing locations, infusion centers, patient monitoring sites and more.

As Eisai continues to build on the Leqembi momentum, the company said it expects selling, general and administrative (SG&A) expenses to increase 2.2% year-over-year to 382.5 billion yen (about $2.5 billion) in 2024 as it plots larger investments in “early expansion of patient contribution for Leqembi.”

Those efforts will include strengthening Leqembi’s U.S. commercial infrastructure and paving the way for a launch in China, where the drug was approved in early January, Eisai explained in its earnings release. Eisai aims to launch Leqembi in China in July, Naito added.

While Eisai appears confident in Leqembi’s ramp-up, executives on Wednesday’s call declined to comment on the number of patients on drug when asked about the company’s previously stated goal to reach 10,000 patients by the end of the 2023 fiscal year.

Back in February, Eisai’s global Alzheimer’s disease officer Keisuke Naito—who is also the son of the company’s CEO—suggested the drugmaker was unlikely to meet that goal.

William Blair analysts Myles Minter and Sarah Schram have estimated there are currently around 5,000 patients on therapy, a 2.5-fold increase from the 2,000 reported in Biogen’s fourth-quarter update.

Eisai reported its Leqembi update shortly after revealing it had started a rolling submission with the FDA for a subcutaneous maintenance dose of the drug, which has now received fast-track designation from the U.S. agency.

The regulatory update, unveiled late Tuesday, came after the FDA in April requested additional three-month immunogenicity data on the proposed autoinjector formulation.

In light of the update, William Blair team wrote in a note to clients Wednesday that they expect the retooled Leqembi delivery format to hit the market in 2025. 

Naito, for his part, thinks subcutaneous Leqembi, if approved, will become a “mainstay formulation,” with Eisai hoping to eventually replace the current infused dosage form with its below-the-skin counterpart for both initial and maintenance treatment.

Πηγή: fiercepharma.com
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