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Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, haematology, oncology and pulmonary disease.
In parallel with its internally developed products, Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, and Novartis.
Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has over 25 programmes in the pipeline and seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis, and has had a collaboration with Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 290 people. More information can be found on www.ablynx.com.
Ablynx has a strong and broad IP position and is the only company in the world with rights in the field of therapy and diagnosis under the granted US and European patents that describe the composition of matter of Nanobodies (the “Hamers patents”), representing a distinct and unique position in the complex field of antibody-derived therapeutics. Nanobody® is a registered trademark of Ablynx NV.
Nanobodies are antibody-derived therapeutic proteins that contain the unique structural and functional properties of naturally-occurring heavy-chain antibodies. The Nanobody technology was originally developed following the discovery that camelidae (camels and llamas) possess fully functional antibodies that lack light chains. These heavy-chain antibodies contain a single variable domain (VHH) and two constant domains (CH2 and CH3). Importantly, the cloned and isolated VHH domain is a perfectly stable polypeptide harbouring the full antigen-binding capacity of the original heavy-chain antibody. These newly discovered VHH domains with their unique structural and functional properties form the basis of a new generation of therapeutic antibodies which Ablynx has named Nanobodies.
Ablynx’s Nanobodies combine the advantages of conventional antibodies with important features of small molecule drugs.
Like conventional antibodies, Nanobodies show:
However, like small molecule drugs they have the opportunity to inhibit enzymes and readily access receptor clefts, which is challenging with conventional antibodies.
To reduce the risk of immunogenicity, Ablynx routinely humanizes its Nanobodies. This is a straightforward procedure because Nanobodies already display relatively high sequence homology to human heavy chain variable domains, typically between 80% and 90% when comparing the framework regions.
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Ablynx currently has commercial collaborations with Boehringer Ingelheim (BI), Merck Serono, Novartis and Pfizer.
The Company intends to selectively enter into new relationships or extend existing partnerships when these could enhance value creation or support risk management. In parallel, Ablynx continues to advance its own Nanobody therapeutic programmes with the goal of building a unique proprietary pipeline.
Alzheimer’s Disease collaboration
In January 2007, Ablynx announced a single target research and licensing agreement with Boehringer Ingelheim (BI) with a potential deal value of €206 million plus royalties. BI and Ablynx collaborate to identify Nanobodies to a specific biological target believed to be relevant in Alzheimer’s disease and BI gains the exclusive worldwide licence to develop and commercialise such Nanobodies. Ablynx received an upfront payment and R&D payments and will further receive milestone payments and royalties when Nanobodies proceed through development and reach the market. In May 2010, BI selected a Nanobody lead candidate for further development for the treatment of Alzheimer’s disease. This is the first lead candidate emerging from the Alzheimer’s disease collaboration and resulted in a €2 million milestone payment to Ablynx.
Strategic Alliance Collaboration
In September 2007, Ablynx entered into a global strategic alliance with 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. Ablynx will have certain co-promotion rights in Europe. To date, Ablynx has earned a total of €20 million in pre-clinical milestone payments as part of this agreement.
In September 2008, Ablynx entered into a collaboration with Merck Serono under which Merck Serono 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 would be 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.
In October 2010, Ablynx and Merck Serono 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 will be 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 Serono on a 50:50 co-development basis until the products reach the market. Ablynx and Merck Serono 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.
In November 2011, Ablynx further expanded its relationship with Merck Serono, 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 will receive an upfront payment of €20 million payable in two tranches over the next three months and will be 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 Serono. At that point, Ablynx has the option to continue with Merck Serono 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.
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, licence 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.
In November 2006, Ablynx entered into a collaboration with Pfizer (formerly Wyeth Pharmaceuticals) with a potential deal value of $212.5 million plus royalties, under which Pfizer received exclusive worldwide development and commercialisation rights to all Nanobodies to TNFα. In November 2011, Ablynx regained the rights from Pfizer to all Nanobodies targeting TNFα.
Phone: +32 9 262 00 00
Fax: +32 9 262 00 01
Foundation date: 7/2001