Galapagos expands osteoarthritis
alliance with GlaxoSmithKline;
GSK makes €4.4 million equity investment in Galapagos
• Up to two drug
discovery programs will be added by GlaxoSmithKline (GSK)
to the existing osteoarthritis alliance with Galapagos
• Galapagos to obtain up to €186 million in total
milestones if the expanded alliance yields 2 marketed products,
plus up to double digit royalties on worldwide sales
• GSK makes €4.4 million equity investment in
Galapagos
Mechelen, Belgium;
2 July 2007 - Galapagos NV (Euronext & LSE: GLPG) announced
today that its existing multiyear alliance in osteoarthritis
with GSK will be expanded, and that Galapagos has issued
513,281 new shares for an investment of €4.4 million
by GSK. GSK will bring a drug discovery program against
a selected GSK target into the alliance. Within this additional
program, Galapagos will progress a disease-modifying drug
towards completion of clinical Phase IIa (“Proof-of-Concept”),
at which point GSK’s global research and development
organization will be responsible for the late-stage development,
production and marketing of the drug. Furthermore, GSK may
add a second osteoarthritis drug discovery program against
a selected GSK target into the alliance.
Upon achievement of a future
milestone event already defined in the original alliance,
Galapagos will receive an additional cash payment from GSK
of €3 million for initiating the first additional program
plus €3 million if GSK brings a second program under
the alliance. In total, for products arising from two new
programs brought into the alliance, Galapagos would receive
up to €32.3 million in development milestones upon
achievement of clinical Proof-of-Concept by Galapagos. Upon
successful completion of all agreed criteria, total cash
value for Galapagos, including the €4.4 million equity
investment, would be €61.7 million for each product,
plus up to double-digit royalties on GSK worldwide sales.
Galapagos could obtain up to €186 million in total
milestones if the expanded collaboration yields 2 marketed
products.
The expansion builds on the
existing strategic alliance between Galapagos and GSK in
osteoarthritis and secures a full exploration of Galapagos
drug discovery capabilities to optimize the value of the
collaboration for both parties. With the expanded alliance
in place, Galapagos and GSK will continue to collaborate
in the existing multiyear alliance as planned, and GSK will
maintain its financial obligations under the original collaboration
agreement. The original alliance carried up to €137
million in upfront, equity and milestone payments for two
marketable products and up to double-digit royalties. Galapagos
already has received €7.6 million in access fees and
milestone payments from GSK since the start of the program
in June 2006.
The expansion broadens the
portfolio of validated targets and compounds in the field
of osteoarthritis. Galapagos pursues medicinal chemistry
programs and develops compounds into candidate selection
molecules through to a successful Proof of Concept in clinical
research Phase IIA. GSK will have exclusive options to further
develop and commercialise these compounds on a worldwide
basis. Galapagos will have the right to further develop
and commercialise compounds for which GSK does not exercise
its option.
As part of the transaction
expanding the alliance, Galapagos and GSK have entered into
an agreement pursuant to which GSK has made an equity investment
of €4.4 million in Galapagos by subscribing to 513,281
newly issued shares from Galapagos at €8.63 per share
(the average Galapagos share price over the last thirty
days prior to 29 June 2007 as quoted on Euronext Amsterdam).
These shares will be subject to a lock up of one year. The
newly issued shares rank pari passu with the existing Galapagos
shares. Galapagos shall within one month from the issue
apply for a listing of the newly issued shares on Euronext
Brussels and Euronext Amsterdam as well as on London AiM.
This investment replaces the up to €3 million equity
investment that was part of the original alliance conditions
announced June 7th 2006 and which was due upon reaching
a certain milestone.
Hugh Cowley, Senior Vice President
of GSK and head of the Center of Excellence for External
Drug Discovery (CEEDD) at GSK noted, “The alliance
between the CEEDD and Galapagos is off to an excellent start,
and the CEEDD is very pleased with the progress to date.
We expect the alliance to contribute to GSK’s development
pipeline in osteoarthritis in the future, validating the
collaboration model we sought to establish under the CEEDD
strategic initiative at GSK.”
“The
expansion of the collaboration announced today shows the
strength of our drug discovery engine and the trust that
GSK has in our capabilities to develop novel drugs,”
said Onno van de Stolpe, Chief Executive Officer of Galapagos.
“Through this combination of GSK’s understanding
of medical needs and Galapagos’ innovation in drug
discovery, we aim to bring new medicines to patients.”
Galapagos’
osteoarthritis program
Galapagos has
an ongoing osteoarthritis research programs and focuses
on chondrocytes, which are the main cell types in cartilage.
These programs will be the basis of the alliance with GSK.
Galapagos has identified a number of novel targets that
have been validated in cellular disease models and has progressed
these into drug discovery. Modulation of these targets in
human chondrocytes should lead to a net production of stable
cartilage and should therefore be able to prevent and repair
damage to this cartilage in patients.
About
osteoarthritis
Osteoarthritis
(OA) is the most common form of arthritis, typically affecting
people aged 45 and older. It is a degenerative disease characterized
by joint destruction and loss of articular cartilage. Cartilage
is the slippery tissue that covers the ends of bones in
a joint. Healthy cartilage allows bones to glide over one
another. It also absorbs energy from the shock of physical
movement. In OA, the surface layer of cartilage breaks down
and wears away. This allows bones under the cartilage to
rub together, causing pain, swelling, and loss of motion
of the joint. Over time, the joint may lose its normal shape.
Also, bone spurs - small growths called osteophytes - may
grow on the edges of the joint. Bits of bone or cartilage
can break off and float inside the joint space. This causes
more pain and damage.
No currently
available treatments prevent OA or even reverse or block
the disease process. Treatment of OA involves pain control,
weight control, and exercise. Many OA patients have pain
that persists despite these measures. Most of these patients
use non-steroidal anti-inflammatory drugs (NSAIDs) that
relieve the symptoms without changing the course of the
underlying disease. Healthcare providers are concerned about
long-term NSAID use due to serious possible side effects.
It is expected
that with the ageing of the population, more individuals
will be prone to develop OA. As mobility of seniors is of
high importance to maintaining a high quality of life, preventing
the severity of OA is seen as an immense clinical need over
the next decade. The market potential of a disease-modifying
drug could exceed $8 billion annually, based on the current
market and the absence of disease-modifying treatment.
About
the GSK CEEDD
GlaxoSmithKline
is enhancing the way it discovers and develops drugs by
creating a small dedicated team who will feed the GSK pipeline
solely through the efforts of its external collaborations.
In essence, the CEEDD (Center of Excellence for External
Drug Discovery) will ‘virtualize’ a portion
of the GSK pipeline; namely, from Target to Clinical PoC,
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 clinical and pre-clinical
programs in bone and joint diseases, cachexia, and menopausal
hot flashes. 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 450 people and
operates facilities in eight 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.
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com
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