11 May 2020 07:00 BST
AstraZeneca has completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. AstraZeneca and Allergan have terminated their previous license agreement and all rights to brazikumab have therefore now returned to AstraZeneca.
Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.
Pursuant to the 2012 collaboration between Amgen and AstraZeneca to jointly develop and commercialise a clinical-stage inflammation portfolio, including brazikumab, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched. This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the medicine with no other payments due to Amgen or Allergan.
Brazikumab is a monoclonal antibody that binds to the IL23 receptor and is in development for CD and UC with a companion biomarker. Brazikumab selectively blocks the IL23 immune signal, preventing intestinal inflammation. In Phase II trials, brazikumab demonstrated a clinical effect at week eight in tumour necrosis factor-resistant CD patients.1 The Phase IIb/III INTREPID programme is underway to assess brazikumab compared to placebo or adalimumab in CD. The Phase II EXPEDITION trial is underway to assess brazikumab compared to placebo or vedolizumab in UC. With current biologic medicines, 40% to 55% of patients have no response to therapy, and 65% to 80% of patients do not experience a full remission.2
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
1. Sands BE, Chen J, Feagan BG et al. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn’s Disease: A Phase 2a Study. Gastroenterology. 2017;153:77-86.
2. Sandborn W. J. (2016). The Present and Future of Inflammatory Bowel Disease Treatment. Gastroenterology & hepatology, 12(7), 438–441.