Biogen

NICE not recommending Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) for NHS use despite MHRA approval for mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD). This follows a similar NICE decision on Eisai/Biogen’s Leqembi (lecanemab) in 2024, due to cost-effectiveness and safety concerns. Both drugs, though representing a breakthrough, have modest efficacy and pose risks like amyloid-related imaging abnormalities (ARIAs). NICE decisions are not final, awaiting further evidence on drug effects and costs. GlobalData forecasts $3.5 billion and $2.0 billion sales for Leqembi and Kisunla, respectively, in the 8MM by 2030.

Livia Fernandes, a biotechnology alumna of Middlesex Community College, returned as an Assistant Professor in 2024. Born in Brazil, she overcame language barriers and pursued her degree at MCC, switching from biology to biotechnology. Her experience at MCC, including internships and flexible scheduling, led to a successful career in biopharma. Now, she aims to foster interactive learning and prepare students for the biotech industry.

Blood tests for Alzheimer’s could provide easier, faster diagnosis, paving the way for earlier intervention and treatment. Several tests are under development, with some showing accuracy similar to cerebrospinal fluid tests. FDA approval for such tests is expected within the next 12 months, potentially leading to earlier detection and more effective treatments.

The global biotechnology market is projected to grow from US$ 550.83 billion in 2024 to US$ 2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR gene editing, and genomic sequencing. Increasing health issues and genetic abnormalities are boosting demand for biopharmaceuticals. North America leads in market share, while India's agricultural biotechnology sector is rapidly expanding.

Eli Lilly’s Kisunla (donanemab) won’t be available to UK Alzheimer’s patients due to NICE’s assessment of poor value for NHS. MHRA approved it for mild cognitive impairment or dementia, but NICE cites uncertainties in benefits and safety concerns like brain swelling or bleeding. Cost-effectiveness estimates are 5-6 times higher than NICE’s acceptable threshold.

Biogen to present new Alzheimer's data at CTAD 2024 in Madrid, including lecanemab treatment, AHEAD 3-45 study, and AI-derived prognostic covariates.

The anti-CD38 mAb market is set to grow due to strong uptake of DARZALEX and expected entry of SARCLISA subcutaneous formulation, driven by rising cancer and autoimmune disorder diagnoses and increasing clinical trials. DARZALEX dominates with 50% usage in second-line Multiple Myeloma treatment, while SARCLISA trails. Emerging indications include Systemic Lupus Erythematosus and Chronic Kidney Disease. Key companies developing anti-CD38 mAbs are Takeda Pharmaceuticals, HI-Bio, and Genmab. Market dynamics face challenges from biosimilar competition and pricing pressures.

The UK launches the Dementia Trials Accelerator (DTA) with £20 million funding to increase dementia trial participation from 61 to tens of thousands. Led by UK DRI and HDR UK, DTA aims to make the UK the top destination for pharma and industry to run late-phase clinical trials, leveraging world-class science and data infrastructure. The initiative addresses obstacles to commercial trials, including streamlined processes, and aims to offer patients access to potentially life-changing treatments through increased trial opportunities.

Multiple sclerosis (MS) is a chronic CNS disease with varied symptoms, caused by immune system attacks on myelin. Biotech companies like Biogen, Immunic Therapeutics, Kyverna Therapeutics, Progentos Therapeutics, TG Therapeutics, and Zenas BioPharma are developing new treatments, including BTK inhibitors, CAR-T therapies, and bispecific antibodies. The global MS drug market is expected to grow significantly, offering hope for more effective treatments for different forms of MS.

Biogen navigates the launch of Alzheimer's drug Leqembi amidst pipeline setbacks, with Leqembi's success crucial for future growth. The company faces competition from Eli Lilly's donanemab and recent pipeline failures, but potential for Leqembi's adoption and pipeline candidates like felzartamab offer growth opportunities.