• Discovery
and development of novel anti-infective medicines based
on Galapagos’ natural product drug discovery platform
• Up to €3.5
million in total technology access fees, up to €215
million in total payments for one marketed product and up
to double digit royalties on commercial sales of alliance
products
GlaxoSmithKline
(GSK) and Galapagos NV (Euronext & LSE: GLPG) announced
today the creation of a multi-year strategic alliance to
develop novel anti-infective drug candidates.
Webcast
audio conference presentation 9.30 CET today
GlaxoSmithKline will participate
in the alliance through its Infectious Diseases Centre of
Excellence for Drug Discovery (ID CEDD). Under the terms
of the agreement, Galapagos will grant GlaxoSmithKline options
to license product candidates that are directed against
up to six anti-infective discovery targets. Galapagos will
be responsible for the discovery and development of natural
product small molecule drug candidates through to clinical
Proof of Concept, at which point GSK will have exclusive
option to license each compound for further development
and commercialisation on a worldwide basis. The alliance
will utilise the natural product compound collection and
chemistry capabilities of BioFocus DPI, Galapagos’
services division. Galapagos will have the right to further
develop and commercialise compounds for which GSK does not
exercise its option.
Galapagos will receive total
upfront fees of up to €3.5 million from GSK, depending
on the total number of programmes within the collaboration.
Galapagos could be eligible to receive up to €95 million
in upfront fees, development and regulatory milestones payments
for each product candidate. If a product is commercialised,
Galapagos may receive up to €120 million for achievement
of specific sales milestones. Galapagos is also eligible
to receive up to double-digit royalties on worldwide sales
of alliance products.
“This is our first
alliance outside bone and joint diseases. It shows that
Galapagos can generate significant business in new therapeutic
areas,” said Onno van de Stolpe, Galapagos’
CEO. “The alliance will rely heavily on BioFocus DPI’s
natural product discovery capabilities. This alliance fits
within our strategy of executing risk/reward sharing deals
with big pharma and at the same time underscores our M&A
approach and successful integration of DPI into the BioFocus
service division.”
“Our newly created
ID CEDD has been focusing on discovering novel antibiotics
and antivirals, and the natural product collections from
BioFocus DPI have the potential to address our needs,”
said Zhi Hong, Senior Vice President and Head of GlaxoSmithKline’s
ID CEDD. “We recognise the significant unmet medical
needs in hospital or community-acquired bacterial infections
plus life-threatening viral diseases. It is therefore prudent
to explore novel chemical space and targets that offer new
prospects for treatments across a range of infectious diseases.
Galapagos has been a productive collaborator for GSK in
the existing osteoarthritis alliance, and we are confident
this new alliance based on natural products will contribute
to the advancement of our drug discovery and development
programmes in infectious diseases.”
About infectious
diseases
Infectious diseases are caused by pathogenic micro-organisms
such as bacteria, viruses, parasites or fungi. The diseases
can be spread, directly or indirectly, from one person to
another . Infectious diseases are a leading cause of death
worldwide. Existing therapies against infectious diseases
currently account for an estimated €45 billion in annual
global sales . The need for new therapies is on the rise
due to increasing resistance of micro-organisms to available
therapies.
About BioFocus DPI
natural product compounds
Natural products represent a major source of new medicines,
as nearly half of all new drugs brought to market in the
last 20 years are derived from compounds of natural origin.
With their unique organic characteristics, natural compounds
are especially important for drug development against certain
target classes. BioFocus DPI’s natural compound collections
are based on bacterial and fungal sources, offering characteristics
differentiating these from synthetic chemistry collections,
including high chemical and functional diversity, potent
pharmacological activities over a broad range of biological
targets, and desirable physicochemical properties.
About GlaxoSmithKline
GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies –
is committed to improving the quality of human life by enabling
people to do more, feel better and live longer. More information
can be found at www.gsk.com.
ABOUT THE ID CEDD
The Infectious Diseases Centre of Excellence for Drug Discovery
is a global research unit within GlaxoSmithKline Drug Discovery
dedicated to discovering therapies for infectious diseases
including bacterial, viral and diseases of the developing
world such as TB and Malaria. It is designed to integrate
and better coordinate the progression of infectious diseases
medicines from therapeutic hypothesis to clinical proof
of concept. It focuses on building an innovative pipeline
through both internal efforts and external alliances with
other companies and research institutions and will focus
on 'virtualising' a portion of the infectious diseases pipeline
by forming multiple risk-sharing/reward-sharing alliances.
About Galapagos
Galapagos (Euronext Brussels, GLPG; Euronext Amsterdam,
GLPGA; London AiM: GLPG) is a drug discovery company with
pre-clinical programs in bone and joint diseases and cachexia.
Its division BioFocus DPI offers a full suite of target-to-drug
discovery products and services to pharmaceutical and biotech
companies, encompassing target discovery and validation,
screening and drug discovery through to delivery of pre-clinical
candidates. BioFocus DPI also provides adenoviral reagents
for rapid identification and validation of novel drug targets,
compound libraries for drug screening as well as chemogenomics
and ADMET database products to select targets and compounds.
Galapagos currently employs 460 people and operates facilities
in seven countries, with global headquarters in Mechelen,
Belgium. More information about Galapagos and BioFocus DPI
can be found at www.glpg.com
and www.biofocusdpi.com.
Conference call
and webcast presentation
Galapagos will host a conference call open to the public
today at 09.30 Central European Time (CET), which will also
be webcast. To participate in the conference call, please
call +32 2290 1791 ten minutes prior to commencement. A
question and answer session will follow the presentation
of the results. To access the webcast, please click
here
The archived
webcast also will be available for replay shortly after
the close of the call.
GlaxoSmithKline
Forward-looking Statements
Under the safe harbour provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors
that any forward-looking statements or projections made
by the company, including those made in this Announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors
that may affect the Group's operations are described under
'Risk Factors' in the `Business Review’ in the company's
Annual Report on Form 20-F for 2006.
Galapagos Forward-looking
Statements
This release may contain forward-looking statements, including,
without limitation, statements containing the words “believes,”
“anticipates,” “expects,” “intends,”
“plans,” “seeks,” “estimates,”
“may,” “will,” “could,”
“stands to,” and “continues,” as
well as similar expressions. Such forward-looking statements
may involve known and unknown risks, uncertainties and other
factors which might cause the actual results, financial
condition, performance or achievements of Galapagos, or
industry results, to be materially different from any historic
or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking
statements. Given these uncertainties, the reader is advised
not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only
as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such forward-looking
statements in this document to reflect any change in its
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement
is based, unless required by law or regulation.