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 R&D 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