Case Study: Ablynx – Merck KGaA Strategic deal

Preset: Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies.

In July 2015 Merck & Co. and Ablynx expanded their 18 month old immuno-oncology collaboration by four years, generating a potential $4.4 billion in milestone payments for Ablynx..

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Recently, Ablynx has received €15 million ($16.9 million) milestone payment from Merck KGaA after the pharma giant approved its preclinical package for ALX-1141, setting the stage for advancing the osteoarthritis candidate into clinical studies.

Merck KGaA will oversee clinical development of ALX-1141.

ALX-1141 is the first candidate to be developed through a 6-year-old collaboration between the companies. Ablynx and Merck KGaA agreed in 2011 to develop candidates against two Merck-selected osteoarthritis targets, with Merck at the time agreeing to pay Ablynx €20 million ($22.5 million) upfront.

Ablynx is eligible for approximately €120 million ($135 million) in development, regulatory, and commercial milestones, plus tiered royalties into double digits, upon successful development and approval of ALX-1141.

ALX-1141 and the second osteoarthritis candidate are being developed using Ablynx’s platform based on single-domain antibody fragments, or Nanobodies®, that contain the unique structural and functional properties of naturally occurring heavy-chain-only antibodies. According to Ablynx, the platform is designed to allow for rapid generation and large-scale production of novel biological therapeutics that have potential in a wide range of human diseases.

The candidate emerged from the third of four collaborations Merck struck with Ablynx. That deal gives Ablynx the option to codevelop assets that advance as far as the clinic. But, in the case of ALX-1141, Ablynx has opted to hand full responsibility for clinical development to Merck in return for up to €120 million in milestones and tiered royalties that run into the double digits.

Those monies will come on top of the €15 million Ablynx received from Merck this week. The 2011 agreement requires Merck to make a payment of that size for each preclinical package it accepts. ALX-1141 is the first program from that agreement to trigger such a milestone payment.

Merck picked out two osteoarthritis targets for Ablynx to work on when it struck the 2011 deal without disclosing their identity. The secretive nature of the project continued throughout the low-profile preclinical development of ALX-1141.

When Merck entered into the osteoarthritis collaboration, it and Ablynx talked up the potential for the single-domain antibody platform to deliver multi-specific candidates with extended half lives. Six years down the line, Ablynx thinks Merck has a possible first-in-class candidate on its hands.

“Our partner Merck has a great deal of experience in osteoarthritis. With no disease-modifying drugs currently approved for osteoarthritis, there is a huge unmet need for new treatments. This Nanobody has the potential to become a first-in-class treatment option for patients suffering from this degenerative joint disease,” Ablynx CEO Edwin Moses said in a statement.

ALX-1141 is set to become the second Ablynx-Merck candidate to enter the clinic. The first, bi-specific anti-IL17A/F antibody ALX-0761, emerged from the 2008 collaboration. Merck licensed the drug in 2013 and went on to post data from a phase 1b psoriasis trial earlier this year.

The programs are part of an expanding clinical pipeline at Ablynx, which has taken lead candidate caplacizumab as far as a filing for approval while seeing its other in-house and partnered assets hustle forward. Boehringer Ingelheim and Novartis join Merck on the list of Ablynx partners that have moved single-domain antibody candidates into the clinic.