GENEVA, Switzerland, October 11, 2010 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and Ablynx today announced that they have expanded their relationship and entered into a second agreement, to co-discover and co-develop Nanobodies against an inflammatory disease target.
Ablynx's Nanobodies are an innovative class of antibody-derived therapeutic proteins that combine the advantages of conventional antibodies with key properties of small molecule drugs such as high affinity, small size allowing alternative delivery and enhanced tissue penetration, and high stability.
In September 2008, Merck Serono and Ablynx entered into an agreement to co-discover and co-develop Nanobodies against two targets in oncology and immunology. This second agreement focuses on the discovery and development of Nanobody-based therapeutics against an inflammatory disease target. This new collaboration structure allows Ablynx to drive the process up to the clinic, leveraging its strengths in Nanobody discovery and preclinical development.
Under the terms of the agreement, Ablynx will receive up-front payment of EUR10 million and be responsible for all activities and costs, excluding manufacturing costs, up to the delivery of a preclinical package that will form the basis for the filing of an IND or IND equivalent. Upon acceptance of the package by Merck Serono, Ablynx will be eligible for a EUR15 million milestone payment. Ablynx has the option to continue with Merck Serono up to 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 significant tiered royalties. Further details of the agreement are undisclosed.
We are very pleased with the progress made to date in our existing collaboration with Ablynx in oncology and immunology and look forward to expanding it to the area of rheumatology where our research focuses on proteins that modulate key pathogenic mechanisms. We believe that the specific features of Nanobodies have the potential to address some of the challenges in treating autoimmune and inflammatory diseases in general, and rheumatology in particular, said Dr Bernhard Kirschbaum, Executive Vice President Research and Development at Merck Serono.
Dr Edwin Moses, CEO and Chairman of Ablynx added: We are delighted to broaden our relationship with Merck Serono. This second collaboration and the novel deal structure underline the confidence that Merck Serono has in our discovery and preclinical development capabilities.
About Ablynx
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 240 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007 and raised EUR50 million through an SPO in March 2010.
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 220 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to address with conventional monoclonal antibodies. Efficacy data have been obtained in 35 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, a subcutaneous administration of the anti-von Willebrand factor (vWF) Nanobody and ALX-0081 entered into a Phase II study in TTP patients in September 2010.
In September 2009, Ablynx's partner Pfizer entered a Phase II study in RA patients, with an anti-TNF-alpha Nanobody.
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 February 2010, Ablynx announced that it had reached its criteria for initiating the preclinical development of ALX-0651, a Nanobody against CXCR4, and will progress this programme towards the clinic. CXCR4 plays an important role in cell mobility, tumor growth and metastasis. In March 2010, Ablynx advanced an anti-RSV Nanobody, ALX-0171, into preclinical development. ALX-0171 will be developed for the treatment of respiratory syncytial virus (RSV) infections, delivered through inhalation and has the potential to be effective both in the prevention of infection as well as in treatment once infection has occurred.
Nanobody(R) is a registered trademark of Ablynx NV.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.
With an annual RD expenditure of more than EUR 1 billion, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck Co. was expropriated and has been an independent company ever since.
For more information, please visit http://www.merckserono.com or http://www.merck.de
SOURCE: Merck Serono
CONTACT: Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève,Suisse, Media relations, Tel: +41-22-414-36-00
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