MZE-001

Eisai's bullish Leqembi sales projection, Takeda's Alzheimer's licensing deal and the latest on the BIOSECURE Act made our news this week. Following a reportedly bullish assessment from Medicare, Eisai has projected a significant sales increase for Leqembi. Takeda paid $100 million upfront for an option to license an anti-amyloid vaccine from AC Immune. The House Oversight Committee voted overwhelmingly to advance a tweaked version of the BIOSECURE Act. And more. 1. Eisai predicts sharp Leqembi sales increase as launch efforts begin to bear fruit After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi Eisai expects Leqembi sales for its 2024 fiscal year will reach 56.5 billion Japanese yen ($364 million), compared with 4.26 billion Japanese yen ($27 million) during the 2023 fiscal year that ended in March. The company believes it and partner Biogen have improved Alzheimer’s disease diagnosis and treatment infrastructure in the U.S. and Japan. Meanwhile, after a short delay, the two companies have started a rolling FDA submission for a subcutaneous version of the anti-amyloid antibody that can be dosed at home. 2. Takeda pays AC Immune $100M upfront for Alzheimer's drug as phase 2 readout nears Fellow Japanese drugmaker Takeda is also making a bet on Alzheimer’s disease, paying $100 million upfront for AC Immune’s anti-amyloid beta vaccines. One candidate in the deal, coded ACI-24.060, is in a phase 1b/2 trial in patients with prodromal Alzheimer’s or Down syndrome. The option exercise fee and milestone payments could add up to $2.1 billion. 3. House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec, WuXi Biologics In new letter to Defense Department, WuXi AppTec refutes claim of secret data transfer The House Committee on Oversight and Accountability voted overwhelmingly to advance the BIOSECURE Act for a full House vote, Reuters reports. The updated version of the bill would give biopharma companies until Jan. 1, 2032, to end their existing contracts with WuXi AppTec and WuXi Biologics plus three gene sequencing firms targeted in the legislation. For potential new targets of the bill, companies would have five years to cut ties with them. Meanwhile, WuXi AppTec is also defending itself against a claim that it shared a U.S. client’s data with Beijing without consent. 4. After FTC stalled Sanofi deal, Shionogi secures Maze's Pompe disease drug for $150M Five months after the U.S. Federal Trade Commission derailed Sanofi’s proposal to acquire Maze Therapeutics’ Pompe disease program, Shionogi has picked up the asset for $150 million upfront and undisclosed milestones. The candidate, MZE001, is a GYS1 inhibitor designed to stop the toxic buildup of glycogen. It has the potential to become the first oral treatment for Pompe. 5. Shionogi's antiviral comes up short in global COVID-19 trial Shionogi also suffered a setback this week. Its once daily protease inhibitor ensitrelvir, which is approved in Japan under the brand name Xocova, failed to significantly beat placebo in reducing the time to sustained resolution of 15 common COVID-19 symptoms in a global phase 3 trial. Despite the primary endpoint miss, Shionogi noted a significant difference in the time to resolution of six COVID symptoms. 6. Hengrui licenses GLP-1 portfolio to $400M biotech startup backed by Bain, Atlas (PDF, Chinese) A new GLP-1 player has emerged with $400 million funding from Bain Capital, RTW Investments, Atlas Venture and Lyra Capital plus a portfolio of three cardiometabolic candidates from Jiangsu Hengrui Pharma. Hengrui out-licensed the meds for $110 million in upfront and near-term payments, plus a 19.9% stake in the startup, called Hercules. One of the candidates is a dual GLP-1/GIP receptor agonist, the same mechanism as Eli Lilly’s tirzepatide. Other News of Note:  7. Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year 8. Radyus and Dt&CRO partner to bring more South Korean biotechs to the US