Current Partnerships

Abbvie

In September 2013, Ablynx and AbbVie entered into a global option license agreement to develop and commercialise the anti-IL-6R Nanobody, vobarilizumab (ALX-0061), to treat inflammatory diseases. The agreement was signed following the successful completion by Ablynx of a Phase IIa study in February 2013 reporting strong efficacy and safety data for vobarilizumab in patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX).

Under the terms of the agreement, Ablynx received an upfront payment of $175 million and is eligible to receive up to $665 million in future milestone payments plus tiered double-digit royalties on net sales upon commercialisation. Ablynx is responsible for completing a Phase IIb RA study in combination with MTX, a Phase IIb RA monotherapy study and a Phase II study in SLE patients. AbbVie has a right to opt-in and license the programme following the completion of the Phase IIb RA studies or after completion of the SLE study. In July and August 2016, Ablynx announced compelling results from the Phase IIb RA studies of vobarilizumab that demonstrated that it has best-in-class potential for the treatment of RA.

On 20 October 2016, Ablynx announced that AbbVie had decided that, at that time, it would not exercise its right to opt-in and license vobarilizumab in RA. Ablynx will rapidly move vobarilizumab into a Phase III RA programme while initiating partnering discussions.

Boehringer Ingelheim

In September 2007, Ablynx entered into a global strategic alliance with Boehringer Ingelheim (BI), with a potential deal value of €1.3 billion plus royalties, to discover, develop and commercialise up to ten different Nanobody therapeutics. Ablynx will receive milestone payments of up to €125 million for each Nanobody that is developed, as well as royalties. Ablynx and BI are collaborating in the discovery of Nanobodies against agreed targets across multiple therapeutic areas including immunology, oncology and respiratory disease. BI will be exclusively responsible for the development, manufacture and commercialisation of any products resulting from the collaboration.

On 4 November 2015, Boehringer Ingelheim presented positive pre-clinical results with the bi-specific anti-VEGF/Ang2 Nanobody in relevant cancer models, demonstrating that this bi-specific Nanobody strongly impairs proliferation and survival of human endothelial cells. In addition, it has superior efficacy as compared to inhibition of the individual pathways by the reference monoclonal antibody drugs and was found to be well tolerated in cynomolgus monkeys. These strong in vivo proof-of-mechanism results support the evaluation of this Nanobody in Phase I clinical studies, which will trigger a milestone payment to Ablynx at study start.
Click here to view the presented poster.

Eddingpharm

First collaboration

In October 2013, Ablynx granted an exclusive, royalty-bearing license to Eddingpharm, a leading Chinese pharmaceutical company, to develop and commercialise its anti-RANKL Nanobody, ALX-0141, in the mainland of the People’s Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases.

Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-RANKL Nanobody therapeutics. Ablynx will have access to the data generated by Eddingpharm to support potential licensing discussions in other geographic regions.

Ablynx has received a €2 million upfront payment from Eddingpharm and is entitled to receive commercial milestone payments plus tiered, double-digit royalties of up to 20%, based on annual net sales of ALX-0141 generated by Eddingpharm in Greater China.

Second collaboration

On 1 September 2014, Ablynx expanded its relationship with Eddingpharm by granting Eddingpharm an exclusive, royalty-bearing license to develop and commercialise Ablynx’s anti-TNFα Nanobody, ozoralizumab (ATN-103), in the mainland of the People’s Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including rheumatoid arthritis (RA).

Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-TNFα Nanobody therapeutics. Ablynx will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions.

Ablynx has received an upfront payment of €2 million and is entitled to receive development and commercial milestone payments plus tiered, double-digit royalties of up to 20%, based on annual net sales of ozoralizumab generated by Eddingpharm in Greater China.

Genzyme

On 18 May 2015, Ablynx entered into an exclusive research collaboration with Genzyme, a Sanofi company, to investigate Nanobodies® against a target that plays an important role in multiple sclerosis (MS) and specifically aligns with Genzyme’s early-stage MS research programs involving neuroprotection and CNS repair.

The neurodegeneration observed in MS is not directly targeted by existing treatments. Genzyme’s research efforts aim to address this unmet need by targeting the underlying causes of MS disease progression and by developing treatments to protect neurons and promote repair of CNS damage.

Under the terms of the agreement, Genzyme will have the right to perform in vitro and in vivo research with Ablynx’s Nanobodies in MS-relevant models in return for an exclusivity fee. Upon completion of these studies, Genzyme will have the option to negotiate a license agreement. Ablynx has already generated potent Nanobodies against the specific target of interest and confirmed their activity in pre-clinical models.

Merck & Co.

First collaboration

In October 2012, Ablynx entered into a collaboration with a subsidiary of Merck & Co. (known outside the US and Canada as MSD.) to develop and commercialise Nanobody candidates directed towards a voltage gated ion channel with the option to develop and commercialise a Nanobody to a second target.

Under the terms of the agreement, Merck gained exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck has paid Ablynx a €6.5 million upfront payment and a €2 million fee for research funding. In addition, Ablynx will be eligible to receive up to €448 million in research, regulatory and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx is responsible for the discovery of Nanobody candidates and Merck will be responsible for the research, development, manufacturing and commercialisation of any Nanobody product resulting from the collaboration.

Second collaboration

In February 2014, Ablynx entered into a second research collaboration and licensing agreement with a subsidiary of Merck & Co. This new exclusive collaboration and licensing agreement is focused on the discovery and development of several predefined Nanobody candidates (including bi- and tri-specifics) directed toward so called “immune checkpoint modulators”, proteins believed to provide potential targets for the development of cancer immunotherapies, a rapidly emerging approach to the treatment of a wide range of cancer types. Under the terms of the agreement, Ablynx received an upfront payment of €20 million and up to €10.7 million in research funding during the initial three year research term of the collaboration. In addition, Ablynx is eligible to receive development, regulatory and commercial milestone payments on achieved sales thresholds for a number of products with ultimate potential to accrue as much as €1.7 billion plus tiered royalties. Merck will be responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.

In July 2015, Ablynx and Merck & Co., Inc. significantly expanded the size and scope of the deal to include up to 12 additional Nanobody programmes against individual protein targets and target combinations (mono-specific and multi-specific Nanobodies) through to the in vivo pre-clinical proof-of-concept stage, after which Merck will have the option to advance specified lead candidates. Under the terms of this four year expansion, Ablynx will receive a €13 million upfront payment comprising exclusivity fees and FTE payments as well as further research funding over the term of the collaboration. In addition, Ablynx will be eligible to receive additional exclusivity fees, depending on the number of programmes for which Merck decides to exercise its licensing option, plus development, regulatory and commercial milestone payments of up to €340 million per programme, as well as tiered royalties on annual net sales upon commercialisation of any Nanobody products. Merck will be responsible for clinical development, manufacturing and commercialisation of any products resulting from the collaboration.

Merck KGaA

 

First collaboration

In September 2008, Ablynx entered into a collaboration with Merck KGaA (previously called Merck Serono) under which Merck KGaA and Ablynx co-discover and co-develop Nanobodies against two targets in immunology and oncology. The agreement included an upfront cash payment to Ablynx of €10 million and both companies will share equally all research and development costs and the resulting profits. Ablynx has options to opt-out during the research and development programmes, in which case Ablynx is eligible to receive milestones and royalties. Total development and commercial milestones, depending on the point of opt-out by Ablynx, could reach up to €325 million should a product be approved in multiple indications in all major markets.

Second collaboration

In October 2010, Ablynx and Merck KGaA entered into a second collaboration to co-discover and co-develop Nanobodies against one inflammatory disease target, more specifically in rheumatology. This agreement included an upfront payment of €10 million for one target and Ablynx is responsible for all activities and costs up to the delivery of a preclinical package (except manufacturing) that will form the basis for the filing of an IND or IND equivalent. Once Ablynx reaches IND stage, Merck Serono has the option to accept Ablynx’s IND package and if they do, Ablynx will receive a €15 million milestone payment and still own 50% of this programme. Ablynx has the option to continue to co-develop together with Merck KGaA on a 50:50 co-development basis until the products reach the market. Ablynx and Merck KGaA will then also share the resulting profits. Ablynx also has the flexibility to convert this collaboration into an exclusive, worldwide licensing deal with milestone payments and significant royalties which are scaled against sales of the products.

Third collaboration

In November 2011, Ablynx further expanded its relationship with Merck KGaA, and entered into a third agreement to co-discover and co-develop Nanobodies against two targets in osteoarthritis. The companies will exploit the unique Nanobody features and will develop multi-specific products, which have extended half-lives.

Under the terms of the agreement, Ablynx has received an upfront payment of €20 million and is fully responsible for all activities and costs for each programme, excluding manufacturing costs and costs relating to certain in vivo models, up to the delivery of the pre-clinical package that will form the basis of an Investigational New Drug (IND) filing or IND equivalent filing. Ablynx is entitled to receive a further €15 million for each programme if the pre-clinical packages are accepted by Merck KGaA. At that point, Ablynx has the option to continue with Merck KGaA on a 50:50 co-development basis and share the resulting profits, or to convert this collaboration into an exclusive, worldwide licensing deal with milestone payments and tiered royalties.

Fourth collaboration

In September 2013, Ablynx and Merck KGaA further expanded their relationship through a multi-year research alliance that could lead to at least four co-discovery and co-development collaborations.

Beginning 2015, both parties mutually agreed to amend this Strategic Collaboration Agreement to focus on two particular bi-specific Nanobody programmes going forward. Ablynx will, at no cost, regain full ownership of three other promising pre-clinical programmes which have been generated under this Strategic Collaboration Agreement in various therapeutic areas, including immuno-oncology. Merck KGaA has provided full financial support for this Strategic Collaboration Agreement, with €11.5 million in non-refundable cash paid to Ablynx so far and approximately €1.0 million to be paid before the end of this year. In addition, Ablynx is eligible to receive future milestone payments and royalties related to the two specific programmes being pursued in this partnership.

Novartis

In December 2005, Ablynx and Novartis entered into an agreement to discover and develop novel Nanobody-based therapeutics against a number of disease targets for a range of disease areas including targets that are difficult to address with conventional antibodies or their fragments.

The deal includes R&D payments, license fees, milestones and royalties. In July 2010, Novartis obtained licenses to further develop and commercialise Nanobodies against two complex targets. This triggered a total of €1 million in upfront fees and license payments to Ablynx. Novartis assumed responsibility for the continued progress of both programmes and Ablynx will be eligible to receive development based milestone payments and royalties on sales following commercialisation of the products.

Novo Nordisk


On 25 November 2015, Ablynx announced that it had entered into a global exclusive collaboration and licensing agreement with Novo Nordisk to discover and develop novel multi-specific Nanobody drug candidates for use in an undisclosed disease area, with an option to expand the agreement to include a second Nanobody programme. 

Under the terms of the agreement, Ablynx will receive an upfront license fee of €5 million and up to €4 million in research funding during the initial three year research term of the collaboration. If Novo Nordisk decides to exercise the option to the second programme, the Company will pay Ablynx an exercise fee of €4 million. In addition, Ablynx is eligible to receive potential development, regulatory and commercial milestone payments of up to €182 million per programme plus tiered royalties on the annual net sales on any products resulting from the collaboration. Novo Nordisk will be responsible for the development, manufacturing and commercialisation of any products resulting from this agreement.

Taisho Pharmaceutical Co., Ltd.

 

In June 2015, Ablynx announced that it had entered into an exclusive license agreement with Taisho Pharmaceutical Co., Ltd., (“Taisho”) for the development and commercialisation of Ablynx’s anti-TNFα Nanobody, ozoralizumab, in Japan,for the treatment of RA.

Under the terms of the agreement, Taisho will be responsible for development, registration and commercialisation of anti-TNFα Nanobody therapeutics in Japan. Ablynx will receive an upfront payment of US$3 million and is entitled to receive development and commercial milestone payments plus royalties based on annual net sales of anti-TNFα Nanobody therapeutics generated in Japan.