Date: 2016-10-03
Type of information: Licensing agreement
Compound: MEDI2070
Company: AstraZeneca (UK) Allergan (Ireland)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Type agreement: licensing
Action mechanism: monoclonal antibody. MEDI2070 is an anti-IL-23 monoclonal antibody.
Disease: Crohn disease, ulcerative colitis
Details: * On October 3, 2016, Allergan announced that it has entered into a licensing agreement with MedImmune, AstraZeneca's global biologics research and development arm, for the global rights to MEDI2070. MEDI2070 is currently in Phase IIb clinical development for the treatment of patients with moderate-to-severe Crohn's disease and is Phase II ready for ulcerative colitis and other related conditions. MEDI2070 is in development as a next-generation IL-23-only targeted therapy for Crohn's disease and ulcerative colitis. These diseases are outside AstraZeneca’s three main therapy areas - Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. MedImmune will continue the ongoing MEDI2070 Phase IIa study in Crohn's disease to completion, and will transition the Phase IIb study in Crohn's disease to Allergan for completion.
MEDI2070 adds to Allergan's position in gastroenterology, with marketed therapies to treat Irritable Bowel Syndrome-C (IBS-C), and Chronic Idiopathic Constipation (CIC), Irritable Bowel Syndrome-D (IBS-D) and Ulcerative Colitis. The acquisition also adds to Allergan's commitment to developing the next generation of autoimmune disorder treatments, including its recently announced acquisition of Vitae Pharmaceuticals and its VTP-43742, a Phase 2 first-in-class, orally active ROR?t (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders.
The transaction is expected to close in the fourth quarter of 2016, subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Financial terms: Under the terms of the agreement, Allergan will make an upfront payment to AstraZeneca of $250 million for the exclusive, worldwide license to develop and commercialize MEDI2070. In addition, Allergan may make potential payments to AstraZeneca of up to $1.27 billion , payable over a period of up to 15 years, including launch milestone payments of up to $435 million and sales-based milestone payments of $725 million , as well as tiered royalties on sales of the product. MedImmune has been leading the clinical development for MEDI2070 under a collaboration agreement AstraZeneca entered into with Amgen in March 2012. Under the conditions of this agreement, AstraZeneca will subsequently pay Amgen one third of all payments and royalties received from Allergan. Amgen will also receive a single-digit percentage inventor royalty on MEDI2070.
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