Ablynx and AbbVie today announced that they 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 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 (RA) on a stable background of methotrexate.

Under the terms of the agreement, 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 totalling up to $665 million as well as double-digit tiered royalties on net sales upon commercialization.

“This deal represents a major milestone for Ablynx and confirms both the potential value of ALX-0061 and the ability of our Nanobody technology to generate clinical candidates with very exciting potential,” said Edwin Moses, Ph.D., chairman and chief executive officer, Ablynx.  “It also demonstrates that we are delivering on our business model of strategic partnering for the development and commercialization of selected programs within our pipeline.  We truly believe that AbbVie’s significant expertise in rheumatology aligns us with the ideal partner to further progress the development of ALX-0061 and to ensure we maximize the potential of this asset.” Dr. Moses added, “the combined clinical expertise of AbbVie and Ablynx will allow us to progress with the rapid development of ALX-0061, with the current plan being the initiation of various clinical trials in both RA and SLE during the course of 2014 and 2015.  We look forward to working together with AbbVie to potentially develop a successful therapy for patients suffering from chronic inflammatory conditions and to making a real difference to the quality of their lives.” “This agreement is further evidence of AbbVie’s commitment to pursue novel treatment options for autoimmune diseases,” said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie.  “Anti-IL-6 antibodies are a proven mechanism of action for autoimmune diseases and ALX-0061 has shown potential in a Phase IIa clinical trial in RA.

 We are looking forward to working with Ablynx to develop a potentially new and effective therapy for patients suffering from serious chronic conditions such as RA and SLE.”