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NORTH CHICAGO, IL and BOSTON, MA, USA I October 28, 2024 I AbbVie (NYSE: ABBV ) and Aliada Therapeutics today announced a definitive agreement under which AbbVie will acquire Aliada, a biotechnology company advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases. Aliada’s lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s disease. “Neuroscience is one of our key growth areas and we are committed to driving innovation in this field to address critical unmet needs for patients living with seriously debilitating neurological diseases such as Alzheimer’s disease,” said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This acquisition immediately positions us to advance ALIA-1758, a potentially best-in-class disease-modifying therapy for Alzheimer’s disease. In addition, Aliada’s novel BBB-crossing technology strengthens our R&D capabilities to accelerate the development of next-generation therapies for neurological disorders and other diseases where enhanced delivery of therapeutics into the CNS is beneficial.” “We are pleased to announce the acquisition of Aliada by AbbVie and are excited about AbbVie’s commitment to bringing ALIA-1758 to patients with Alzheimer’s disease. Our proprietary MODEL™ platform has enabled the development of ALIA-1758, a promising step forward in brain delivery of an anti-amyloid antibody therapy,” said Michael Ryan, M.D., chief medical officer at Aliada Therapeutics. “Many promising CNS-targeted therapies fail to reach late-stage trials due to their inability to cross the blood-brain barrier. Our MODEL™ platform addresses this challenge directly, efficiently delivering targeted drugs and potentially transforming how we treat neurological diseases.” Aliada is advancing therapeutic candidates using its Modular Delivery (MODEL™) platform, engineered for high-precision CNS drug delivery. The novel BBB-crossing technology targets transferrin and CD98 receptors (TfR and CD98) which are highly expressed in brain endothelial cells. By engineering highly optimized TfR or CD98 binders, this platform is designed to deliver different types of biological cargoes into the brain, including therapeutic antibodies and genetic medicines such as siRNA. ALIA-1758 utilizes TfR to transport a 3pE-Aβ antibody across the BBB to enable degradation and elimination of amyloid beta plaques, a pathological hallmark of Alzheimer’s disease. This investigational candidate is currently in a Phase 1 clinical trial to assess its safety and tolerability in healthy participants (NCT06406348). Under the terms of the agreement, AbbVie will acquire all outstanding Aliada equity for $1.4 billion in cash, subject to certain customary adjustments. This transaction is expected to close in 4Q2024, subject to regulatory approvals and other customary closing conditions. Advisors AbbVie’s legal advisor was Covington & Burling LLP. Aliada’s exclusive financial advisor was Centerview Partners LLC and Fenwick & West LLP served as legal advisor. About AbbVie AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube. About Aliada Therapeutics Aliada Therapeutics is a biotechnology company focused on addressing delivery challenges in CNS drug development. Aliada is developing next-generation CNS therapeutics with its novel BBB-crossing Modular Delivery (MODEL™) platform technology, which has been shown to efficiently transport diverse therapeutic cargoes into the brain, enhancing effectiveness and addressing the critical need for efficient and versatile large molecule and oligonucleotide delivery. Johnson & Johnson (through its venture capital arm, Johnson & Johnson Innovation – JJDC, Inc.), RA Capital Management, and Raven (RA Capital Management’s incubator) co-founded Aliada and co-led the series seed financing in 2021 to advance the MODEL™ platform created by Johnson & Johnson scientists that was licensed to Aliada at its inception. Further investment was made by OrbiMed and Sanofi Ventures. For more information visit www.aliadatx.com and follow us on LinkedIn and X . SOURCE: AbbVie

iStock/ Evgeny Gromov The acquisition of Aliada Therapeutics gives AbbVie access to a Phase I anti-amyloid antibody as well as the biotech’s novel platform engineered for efficient blood-brain barrier transport. With several early- to mid-stage assets already in its pipeline , AbbVie took an even deeper dive into the Alzheimer’s space Monday with the acquisition of Aliada Therapeutics. At the heart of the deal—which will see AbbVie pay $1.4 billion in cash to acquire the Boston-based biotech—is ALIA-1758, an anti-amyloid antibody currently in Phase I development for Alzheimer’s disease. This is the same drug class that recently burst onto the scene in the form of Biogen/Eisai’s Leqembi and Eli Lilly’s Kisunla , both approved in the last two years as the first disease-modifying therapies for Alzheimer’s. The acquisition also gives AbbVie access to Aliada’s Modular Delivery (MODEL) platform, which is “engineered for both efficient BBB (blood-brain barrier) transport and downstream therapeutic functionality,” according to the company’s website . In an investor note Monday, BMO Capital Markets analyst Evan David Seigerman said BMO views the deal “as positive for AbbVie shares, albeit risky given the indication and stage of development, expanding into a therapeutic area it knows well and continuing to bolster its pipeline for long term growth beyond recent commercial success with Skyrizi & Rinvoq.” Stifel analysts added in an investor note that the deal “seemingly offers a vote of confidence in amyloid, just as sentiment in the space is reaching an all-time low.” ALIA-1758 targets pyroglutamate amyloid beta, which is similar to the epitope targeted by Eli Lilly’s Kisunla , John Dunlop, chief scientific officer at Aliada, previously told BioSpace . The novel technology targets transferrin and CD98 receptors TfR and CD98, which are highly expressed in the brain’s endothelial cells, and uses the transferrin receptor to drive its cargo to cells and force degradation and elimination of the plaques, Dunlop explained. By transporting the cargo in this way, a higher concentration of the antibodies is delivered across the blood-brain barrier to drive therapeutic benefit. “Many promising CNS-targeted therapies fail to reach late-stage trials due to their inability to cross the blood-brain barrier,” Michael Ryan, chief medical officer at Aliada, said in a statement Monday, adding that the company is “excited about AbbVie’s commitment to bringing ALIA-1758 to patients with Alzheimer’s disease.” AbbVie already has a considerable presence in the Alzheimer’s R&D space, and Seigerman noted that Aliada’s assets are potentially complementary to a number of Alzheimer’s assets that AbbVie already has in development. The company’s pipeline includes ABBV-916, an anti-AβpE3 antibody; ABBV-552, an SV2A modulator being evaluated to target nerve terminals to enhance synaptic efficiency; and AL002, an antibody being developed in partnership with Alector Therapeutics. “Neuroscience is one of our key growth areas and we are committed to driving innovation in this field to address critical unmet needs for patients living with seriously debilitating neurological diseases such as Alzheimer’s disease,” Roopal Thakkar, EVP of research and development and chief scientific officer at AbbVie, said in a statement . Aliada’s platform “strengthens our R&D capabilities to accelerate the development of next-generation therapies for neurological disorders and other diseases where enhanced delivery of therapeutics into the CNS is beneficial.” The deal is expected to close in the fourth quarter of 2024, subject to regulatory approvals and other customary closing conditions.

A new Alzheimer's treatment, donanemab, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but a draft decision by the National Institute for Health and Care Excellence (NICE) has rejected the drug for use on the NHS. Manufactured by Eli Lilly, donanemab, also known as Kisunla, is designed to slow cognitive decline in patients with early-stage Alzheimer’s disease by targeting beta-amyloid plaques in the brain, a known cause of the condition. The decision from NICE, published today (23 October 2024), has sparked frustration within the Alzheimer’s community, especially following NICE's similar rejection of another Alzheimer’s drug, lecanemab, just months earlier. While both treatments represent a breakthrough in addressing the disease's underlying cause rather than just managing symptoms, NICE determined that donanemab does not currently demonstrate sufficient value for NHS use due to its high costs and limited benefits. According to NICE's independent committee, clinical evidence showed that donanemab could slow the progression of Alzheimer’s disease by 4 to 7 months. However, the cost-effectiveness estimate for the drug was found to be five to six times higher than what NICE typically considers acceptable. Helen Knight, director of medicines evaluation at NICE, stated, “While the drug offers some benefit, this is just not enough to justify the significant cost to the NHS.” She emphasized that the draft decision could be revisited pending further evidence from Eli Lilly and NHS England. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Despite the MHRA’s approval, NICE raised concerns over the drug’s safety profile, as 33% of trial participants experienced amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding. The treatment also requires monthly hospital infusions and intensive monitoring, adding to the costs. With an estimated 70,000 patients in England eligible for the treatment, the financial strain on the NHS was a critical factor in NICE’s rejection. Alzheimer's Society - mixed emotions The UK’s leading dementia charity, Alzheimer’s Society, responded to the news with mixed emotions. While celebrating the MHRA’s approval, the charity expressed disappointment with NICE’s draft guidance. Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, remarked, “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia. However, we respect NICE's decision and hope to see improvements in the affordability and efficacy of treatments over time, as we have seen in other diseases like cancer.” Alzheimer’s Society funded the research that identified the role of amyloid plaques 30 years ago, laying the groundwork for today’s treatment developments. The charity continues to advocate for better access to treatments and early diagnosis, highlighting that more than a million people live with dementia in the UK, many without a diagnosis. Professor Carragher emphasized, “New treatments are only one part of the solution. We must ensure that people with dementia have access to timely and accurate diagnosis so they can benefit from the treatments available now and in the future.” As the landscape for Alzheimer’s disease treatment evolves, NICE has announced that it is monitoring around 27 new products in the pipeline. The organization also plans to revisit its suite of guidance on Alzheimer’s care and diagnostics, including researching blood biomarkers for earlier and more accurate detection. The consultation period for NICE’s draft guidance on donanemab will run until 20 November 2024, during which further evidence and responses will be reviewed. A final decision on donanemab’s NHS availability is expected in the coming months. Meanwhile, the Alzheimer’s community continues to await the final recommendations for lecanemab, with its second committee meeting scheduled for November 2024.