The News

Ablynx wins patent opposition case against Domantis (GSK)

11/02/2010

GHENT, Belgium, 11 February 2010 - Ablynx [Euronext Brussels: ABLX] today announced that it has been successful in the opposition that it had filed in 2007 against the European Patent 1 517 921, which was granted in 2006 to Domantis (now a member of the GlaxoSmithKline group of companies). As a result, the Opposition Division of the European Patent Office yesterday decided to revoke the Domantis patent in full. If this decision becomes final, all the claims of this patent as originally granted will be deemed to have never existed.
The European Patent 1 517 921 related to one specific technique for the half-life extension of immunoglobulin single variable domains. Without this patent, the techniques described in this patent can be applied by Ablynx and its partners in Europe for their internal and partnered programmes without Domantis being able to assert this patent against such activities in Europe.

Edwin Moses, CEO and Chairman of Ablynx, commented:
“This is the result that we always anticipated. From all the evidence available to us, we strongly believe that our current half-life extension technologies currently outperform those of GSK/Domantis, and that once this patent has been finally revoked, we and our partners can be confident that we will have yet another half-life extension technology available to us that we can use without being encumbered by third party patent rights. This is in addition to our own proprietary NExpedite® technology, which is showing ever greater promise. All this will allow us to even further exploit our already well established technical lead over GSK/Domantis, which is for example evidenced by our recent advances in making Nanobodies against some complex targets and classes of targets (such as G-Protein Coupled Receptors (GPCRs), ion channels and viruses). Also, our Nanobody technology has extensive patent protection and four Nanobody based products are currently in clinical trials.”
Domantis is expected to appeal the decision by the Opposition Division, but Ablynx sees no reason why the arguments that were successful for Ablynx in the opposition proceedings should not be equally successful in appeal. Under the provisions of the European Patent Convention, an appeal filed by Domantis will suspend the decision of the Opposition Division.

About Ablynx [Euronext Brussels: ABLX] -
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on 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. The Company currently has over 230 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx now has over 25 programmes in its therapeutic pipeline including four Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 190 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to approach with conventional monoclonal antibodies. Efficacy data have been obtained in 28 in vivo models for Nanobodies against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 130 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies.
Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer (previously Wyeth Pharmaceuticals). Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.
The Company’s lead programme, ALX-0081, an intravenously administered novel anti-thrombotic entered a Phase II study in patients undergoing percutaneous coronary intervention (PCI) in September 2009. Ablynx demonstrated proof-of-concept by biomarker for ALX-0081 in December 2009. ALX-0681 subcutaneous administration of the anti-von Willebrand factor (vWF) Nanobody has concluded Phase I.
In December 2009, Ablynx initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women. ALX-0061, an anti-IL6R Nanobody is in preclinical development for the treatment of autoimmune and inflammatory diseases. In addition, in September 2009, Ablynx’s partner Pfizer entered a Phase II study in RA patients, with an anti-TNF-alpha Nanobody.
Nanobody® is a registered trademark of Ablynx NV.

For more information, please contact:
For international media enquiries: College Hill Life Sciences

Ablynx:
Sue Charles, Justine Lamond
t: +44 (0)20 7866 7857
e: ablynx@collegehill.com

Dr Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
e: edwin.moses@ablynx.com

Eva-Lotta Allan
Chief Business Officer
t: +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
e: eva-lotta.allan@ablynx.com

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