EISAI CO

Lilly’s Alzheimer’s drug Kisunla gets MHRA approval but NICE rejects it, citing lack of value for NHS.

NHS rejects Alzheimer's drug donanemab, citing lack of value for money. Donanemab, made by Eli Lilly, slows early Alzheimer's stages but cost-effectiveness is 5-6 times above what NHS considers acceptable. This follows a similar rejection of lecanemab by the National Institute for Health and Care Excellence (Nice).

Eisai anticipates a Q2 EU decision on Bioarctic's lecanemab, with the EMA's Scientific Advisory Board meeting in Q1 to discuss the marketing authorization application. Bioarctic and Eisai plan joint Nordic commercialization post-approval, with global collaboration involving Biogen.

Roche ends partnership with UCB in Alzheimer’s disease, returning rights to Phase IIa prospect bepranemab, marking Roche’s second Alzheimer’s partnership cut this year. UCB announced the partnership termination as it prepares to present Phase IIa study results at the 2024 Clinical Trials on Alzheimer’s Disease Meeting. Roche, lagging in Alzheimer’s treatment development, continues to explore early-stage assets like RG6289 and trontinemab.

Simoa® technology, an ultra-sensitive immunoassay platform, is revolutionizing biomarker detection in neurological research and drug development, enabling earlier and more accurate diagnosis of diseases like Alzheimer’s. Its enhanced sensitivity allows for the detection of low-abundance biomarkers, such as NF-L and pTau proteins, which are crucial for early intervention and treatment efficacy monitoring. Simoa’s role in drug development and patient management is expected to grow, offering non-invasive, cost-effective methods for disease tracking and potentially transforming patient outcomes.

The ADC market, driven by technological advancements and personalized medicine, is expected to reach ~USD 26 billion by 2030 with a CAGR of ~14%. North America leads due to high cancer incidence and strong biopharmaceutical sector. Key players include F. Hoffmann-La Roche Ltd, DAIICHI SANKYO COMPANY, LIMITED, and Pfizer Inc. The market is dynamic, influenced by regulatory frameworks and innovation in linker technologies and payloads.

EMA won't renew Translarna's permit; Novartis pays $70M for a cancer drug; Amylyx's AMX0035 shows promise in rare disease; FDA delays Ocaliva approval; Australia rejects Leqembi; Amicus settles with Teva over Galafold.

With two anti-amyloid Alzheimer’s drugs on the market, investors are focusing on new tests and biomarkers to boost treatment and prevention. The Alzheimer’s Drug Discovery Foundation, backed by billionaires and industry players, has funded companies like C2N Diagnostics and Fujirebio, which are developing more accurate detection methods. The foundation aims to diversify beyond amyloid, focusing on the biology of aging for future Alzheimer’s treatments.

Sage Therapeutics cuts staff, Eisai/Biogen's Leqembi rejected in Australia, Sanofi invests in Orano Med, Novartis licenses Chinese cancer treatment, telehealth's GLP-1 boom driven by select doctor groups, former Trump official calls for IRA revisit, BMS CEO discusses company pivot, Lilly CSO warns against weakening patents, GLP-1s linked to lower opioid overdose risk, Novavax faces vaccine setback.

Australia's TGA won't approve Eisai and Biogen's Alzheimer's therapy Leqembi, citing insufficient efficacy and safety risks like ARIA. Eisai Australia plans to request a reconsideration. Leqembi is already approved in the US, Japan, China, and other countries.