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A licensing/option deal in which Genentech (Roche) took rights to AC Immune's anti-phospho-Tau immunotherapy program, led by semorinemab, for Alzheimer's disease, worth up to $570M in milestones plus royalties—a slow-burn bet on tau pathology that still lacked a disclosed upfront figure.
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AC Immune anti-tau drug semorinemab, developed in collaboration with Roche Genentech unit, failed its primary endpoint in the Phase 2 TAURIEL trial evaluating…
Genentech licensed rights to crenezumab in 2006, and in 2012 broadened the partnership to include semorinemab. The two deals had a combined value of more than…
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Genentech (Roche) licensed AC Immune's anti-phospho-Tau immunotherapy program for Alzheimer's disease. AC Immune received upfront and near-term payments, with total potential value up to $570M in milestones plus royalties. The collaboration targets phosphorylated tau protein, a key pathological marker in Alzheimer's and other tauopathies.
AC Immune's PI-2620 is a tau PET imaging agent (diagnostic radiopharmaceutical), not a therapeutic — competitive landscape applies at the diagnostic level. Tau PET tracers: flortaucipir (Tauvid, Lilly/Avid; FDA-approved 2020 for AD), PI-2620 (Roche/Life Molecular Imaging). Alzheimer's/PSP/tauopathy therapeutics are a different competitive set (anti-amyloid: lecanemab/Leqembi, donanemab/Kisunla; anti-tau: semorinemab, bepranemab, others). The deal context surfaces diagnostics adjacent to Roche's tau therapeutic pipeline. Split into 'PI-2620 imaging' and 'tau therapeutic' rows for proper landscapes.
ACI-24.060 is an anti-Abeta active immunotherapy (vaccine) in Phase 2 ABATE. The AD therapeutic landscape is stratified across three disease-modifying MOA classes plus symptomatic agents. Anti-amyloid passive mAbs (approved class): Leqembi (lecanemab, Eisai/Biogen) received traditional FDA approval in July 2023 for early AD with Eisai reporting FY2024 (Mar-end) sales of ~JPY 42B ($280M) ramping; Kisunla (donanemab, Lilly) received FDA approval in July 2024 based on TRAILBLAZER-ALZ 2, with limited-duration dosing until plaque clearance. Anti-amyloid active immunotherapy (same class as ACI-24.060): Vaxxinity's UB-311 (Phase 2), Prothena's PRX012 passive alternative, and Novo Nordisk/Prothena combined programs represent pipeline peers; no vaccine has ever completed Phase 3. Symptomatic AChE/NMDA: Aricept (donepezil, generic), Exelon (rivastigmine), Namenda (memantine) dominate legacy prescribing. Anti-tau pipeline: Lilly's zagotenemab (discontinued), Biogen/Ionis's BIIB080/tau ASO (Phase 2), AbbVie's ABBV-8E12/tilavonemab. Commercial threat assessment for ACI-24.060: vaccine approach promises durability and cost advantages versus Q2W/Q4W mAb infusions but must overcome historical vaccine failures (AN-1792, CAD106) and demonstrate non-inferior plaque reduction to lecanemab/donanemab on amyloid PET.
ACI-7104.056 is an anti-alpha-synuclein active immunotherapy (vaccine) for Parkinson's disease, Phase 2. No disease-modifying therapy is approved for PD; the DMT landscape is stratified by MOA class. Anti-alpha-synuclein passive mAbs (direct competitor class): Roche/Prothena's prasinezumab (PRX002/RG7935) reported nominally positive Phase 2b PADOVA hierarchical endpoint data in 2024 and is in ongoing Phase 3-ready development; Lundbeck's lu AF82422 is Phase 2. Active immunotherapy (same class as ACI-7104.056): Vaxxinity's UB-312 (Phase 1) is the other vaccine program in development. LRRK2-targeted ASOs: Biogen/Ionis's BIIB094/ION859 (Phase 1) and Denali/Biogen's small-molecule LRRK2 inhibitor BIIB122/DNL151 (Phase 3 LUMA, LIGHTHOUSE). GBA1-directed: Sanofi/Genzyme's venglustat (discontinued), Prevail/Lilly's LY3884961 gene therapy. Symptomatic dopaminergics (off-target but competitive for commercial share): Sinemet (levodopa/carbidopa) and all generics, Rytary, Nourianz (istradefylline, Kyowa Kirin), and Gocovri (amantadine ER). Commercial threat sizing for ACI-7104.056: vaccine durability and cost-of-goods advantage versus Q4W prasinezumab infusion is the key wedge, but AC Immune trails prasinezumab by ~3-4 years in clinical development; commercial positioning depends on UPDRS and biomarker non-inferiority.
Neuro-inflammation is a mechanism/platform label spanning Alzheimer's, MS, ALS, FTD, Parkinson's. Approved neuroinflammation-modulating therapies: dimethyl fumarate (Tecfidera, Biogen; MS), ocrelizumab (Ocrevus, Roche; MS), edaravone (Radicava, Mitsubishi Tanabe; ALS), tofersen (Qalsody, Biogen; SOD1 ALS). Investigational: semorinemab (RG6100, Roche/AC Immune; anti-tau mAb, Phase 2 LAURIET failed in AD 2022, Phase 2 in PSP ongoing), ION269 (AZ/Ionis; tauopathies), multiple ASO programs. Roche/AC Immune's collaboration targets tau specifically; broader neuroinflammation label aggregates.
AD in Down syndrome (DSAD) is an ultra-rare, genetically defined indication where trisomy 21 triple-copies APP, guaranteeing amyloid pathology by mid-life. No therapy is DSAD-labeled; the competitive set draws from sporadic AD programs extended into the DSAD population. Anti-amyloid passive mAbs: Leqembi (lecanemab, Eisai/Biogen) and Kisunla (donanemab, Lilly) have FDA approvals in early AD and are being studied in DSAD via the Trial-Ready Cohort-Down Syndrome (TRC-DS) and ACTC investigator networks, though ARIA-E/H risk in a high-cerebral-amyloid-angiopathy population is a commercial and safety concern. Anti-amyloid active immunotherapy (direct competitor class for ACI-24.060): ACI-24.060 has a dedicated Phase 1b/2 ABATE-DS cohort in adults with DS, making AC Immune the leader in DSAD-specific vaccine development. No competing Abeta vaccine (UB-311/Vaxxinity) has announced DSAD-specific trials. Supportive/symptomatic care: Aricept (donepezil), Namenda (memantine), and Exelon (rivastigmine) remain off-label prescribed. Commercial threat sizing: DSAD is an orphan opportunity (~200K US adults with DS aged 40+) with clean regulatory pathway potential; ACI-24.060's DS-first strategy creates a first-mover advantage provided safety in a cerebral amyloid angiopathy-enriched population exceeds anti-amyloid mAbs.
Genentech/Roche licensed anti-phospho-Tau immunotherapy for Alzheimer disease. Up to $570M milestones.
Phase 2 TAURIEL failed. LAURIET showed mixed results (cognition benefit but no functional benefit). Roche ended deal.
Semorinemab failed to show consistent clinical benefit. 12+ year collaboration terminated. Anti-tau approach questioned.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Roche Holding AG / AC Immune SA (this deal) | 2012 | $570M | 41 |
| Roche Holding AG / Chugai Pharmaceutical Co. Ltd. | 2002 | $1.4B | 100 |
| Roche Holding AG / Ventana Medical Systems Inc. | 2008 | $3.4B | 88 |
| Roche Holding AG / Corange Ltd. (Boehringer Mannheim Group) | 1997 | $11.0B | 88 |
| Roche Holding AG / Ventana Medical Systems Inc. | 2007 | $3.4B | 88 |
| Roche Holding AG / Foundation Medicine, Inc. | 2015 | $1.1B | 87 |
| Roche Holding AG / Foundation Medicine, Inc. | 2018 | $5.3B | 85 |
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