Date: 2013-09-23
Type of information: Licensing agreement
Compound: ALX-0061
Company: Ablynx (Belgium) AbbVie (USA -IL)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement: licensing
Action mechanism: IL-6 and its receptor IL-6R are involved in the pathogenesis of various inflammatory and auto-immune diseases, including RA. ALX-0061 is a Nanobody binding to the interleukin-6 receptor (IL-6R). It has the potential to be differentiated from the benchmark monoclonal antibody through its high potency, high stability and low molecular weight of only 26kD which could translate into superior tissue penetration, attractive PK/PD and a superior safety and efficacy profile. The Nanobody is half-life extended with a Nanobody targeting albumin, which is believed to improve the delivery of the Nanobody to inflamed tissues.
Disease: rheumatoid arthritis, systemic lupus erythematosus
Details: * On September 23, 2013, Ablynx and AbbVie have entered into a global license agreement to develop and commercialise the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases. ALX-0061 is Ablynx\'s proprietary anti-IL-6R Nanobody that successfully completed a Phase IIa study in February 2013 reporting strong efficacy and safety data in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. Under the terms of the agreement, Ablynx will be responsible for completing Phase II clinical development in both rheumatoid arthritis and systemic lupus erythematosus. Upon the achievement of pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation. Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg.
The two partners intend to initiate various clinical trials in both rheumatoid arthritis and systemic lupus erythematosus during the course of 2014 and 2015.
Financial terms: Ablynx will receive an upfront payment of $175 million, which will partly be used to fund the next phases of clinical development of ALX-0061. Upon achievement of certain development, regulatory, commercial and sales-based milestones, Ablynx will be eligible to receive additional milestone payments totalling up to $665 million as well as double-digit tiered royalties on net sales upon commercialisation.
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