Belgian drug developer Ablynx (Euronext Brussels: ABLX) and US drugmaker AbbVie (NYSE: ABBV) have entered into a global license agreement to develop and commercialize the anti-IL-6R nanobody, ALX-0061, to treat inflammatory diseases. ALX-0061 is Ablynx’s proprietary anti-IL-6R nanobody which successfully completed a Phase IIa study in February 2013 reporting strong efficacy and safety data in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Ablynx will be responsible for completing Phase II clinical development in both RA and systemic lupus erythematosus (SLE). 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 commercialization. Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg.
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 totaling up to $665 million as well as double-digit tiered royalties on net sales upon commercialization.
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