ABLYNX'S PARTNER INITIATES A PHASE I STUDY AND DOSES FIRST HEALTHY VOLUNTEER WITH ALX-0761
(Thomson Reuters ONE) -
GHENT, Belgium, 21 June 2013 - Ablynx [Euronext Brussels: ABLX] today announced
that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has
dosed the first healthy volunteers in a Phase I clinical trial as part of the
evaluation of the Nanobody®, ALX-0761, for the treatment of inflammatory
diseases.
ALX-0761 is the first clinical Nanobody candidate to emerge from the
collaboration which the companies entered into in 2008.
The collaboration agreement allows Ablynx to convert, at certain time-points in
the development, the 50-50 co-discovery and co-development collaboration into a
license agreement. At this point, Ablynx has decided to convert this
collaboration into a license agreement, and as a result, Merck Serono now has an
exclusive worldwide license agreement for ALX-0761. Ablynx is eligible to
receive additional development milestone payments associated with the progress
of the product in multiple indications as well as regulatory and commercial
milestones plus tiered royalties upon approval of the product. The start of the
Phase I study triggers a ?2.5 million milestone payment to Ablynx.
The Phase I study involves a single-centre, randomised, double-blind, placebo-
controlled trial to assess the safety, pharmacokinetics and pharmacodynamics of
single ascending doses of subcutaneous injections with ALX-0761 in healthy
subjects.
"We are very pleased to see our first programme with Merck Serono advancing into
clinical development, less than five years since the start of our
collaboration," said Dr Edwin Moses, Chairman and CEO of Ablynx. "We have now
reached the point at which we will rely on Merck Serono's considerable resources
and expertise to take this programme forward. We remain committed to continue to
work closely with our partner not only on ALX-0761 but on the other four co-
discovery and co-development programmes where we are currently collaborating."
About the Merck Serono partnerships
In September 2008, Ablynx entered into an agreement with Merck Serono under
which Merck Serono and Ablynx co-discover and co-develop Nanobodies against two
targets in immunology and oncology. Both companies agreed to share equally all
research and development costs and the resulting profits. Ablynx has options to
opt-out during the research and development programmes.
In October 2010, Ablynx and Merck Serono entered into a second co-discovery and
co-development agreement to develop Nanobodies against one single target in
inflammation. Ablynx received an upfront fee and retained full control to drive
the process up to the investigational new drug (IND) application.
In November 2011, Ablynx and Merck announced that they have further expanded
their relationship and entered into a third agreement to co-discover and co-
develop Nanobodies against two targets in osteoarthritis. Ablynx received an
upfront fee 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 IND filing or IND equivalent filing.
About Ablynx
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 human diseases, including
inflammation, haematology, oncology and pulmonary disease. Today, the Company
has approximately 25 programmes in the pipeline and six Nanobodies are at
clinical development stage. Ablynx has on-going research collaborations and
significant partnerships with major pharmaceutical companies including
Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co. The Company is
headquartered in Ghent, Belgium. More information can be found on
www.ablynx.com.
For more information, please contact
Ablynx:
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(at)ablynx.com
Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
Follow us on Twitter (at)AblynxABLX
M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx(at)mcomgroup.com
Press release in pdf format:
http://hugin.info/137912/R/1710942/567543.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
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