Eisai projects Leqembi growth; Takeda secures Alzheimer's drug; BIOSECURE Act progresses

Eisai has projected a significant rise in sales for Leqembi, its Alzheimer's treatment, estimated to hit 56.5 billion Japanese yen ($364 million) for the fiscal year 2024. This marks a substantial increase from the previous fiscal year's sales of 4.26 billion yen ($27 million). Eisai, along with its partner Biogen, attributes this growth to enhanced Alzheimer’s diagnosis and treatment infrastructure in both the U.S. and Japan. Concurrently, after a brief delay, the companies have initiated a rolling FDA submission for a subcutaneous version of Leqembi, which can be administered at home.

In another development in the Alzheimer's treatment arena, Takeda has made a significant investment by paying $100 million upfront to AC Immune for an anti-amyloid beta vaccine. This partnership includes a candidate known as ACI-24.060, currently undergoing a phase 1b/2 trial in patients with prodromal Alzheimer’s or Down syndrome. The potential financial commitment from Takeda could reach $2.1 billion, factoring in option exercise fees and milestone payments.

On the legislative front, the House Committee on Oversight and Accountability has made strides with the BIOSECURE Act. The committee voted to advance the bill for a full House vote. The revised bill requires biopharma companies to terminate contracts with WuXi AppTec, WuXi Biologics, and three gene sequencing firms by January 1, 2032. For any new entities targeted by the bill, companies would have five years to end their associations. Additionally, WuXi AppTec is currently defending itself against allegations of unauthorized data sharing with Beijing.

In the context of acquisitions, Shionogi has gained the rights to Maze Therapeutics’ Pompe disease program for $150 million upfront, after the U.S. Federal Trade Commission halted Sanofi’s acquisition attempt. The drug candidate, MZE001, is designed to inhibit GYS1 and prevent harmful glycogen accumulation, with the potential to be the first oral treatment for Pompe disease.

Shionogi also faced challenges this week, as its antiviral drug ensitrelvir, sold under the brand name Xocova in Japan, did not meet the primary endpoint in a global phase 3 COVID-19 trial. The drug failed to significantly reduce the time to sustained resolution of 15 common COVID-19 symptoms compared to a placebo. However, Shionogi reported a notable difference in the resolution time of six specific COVID symptoms.

A new player in the GLP-1 space has emerged, backed by $400 million in funding from Bain Capital, RTW Investments, Atlas Venture, and Lyra Capital. This startup, named Hercules, has licensed a portfolio of cardiometabolic treatments from Jiangsu Hengrui Pharma, which includes a dual GLP-1/GIP receptor agonist similar to Eli Lilly’s tirzepatide. Hengrui has received $110 million in upfront and near-term payments and holds a 19.9% stake in Hercules.

In additional news, Aurobindo's Eugia has received its fifth Form 483 from the FDA within a year, drawing attention to the company’s compliance practices. Meanwhile, Radyus and Dt&CRO have formed a partnership aimed at assisting South Korean biotechs in entering the U.S. market.