• Gene to clinical Proof of Concept for multiple targets
in osteoarthritis
• €4 million technology access fee payment
• Up to €130 million in milestones for two marketable
products
• Up to double digit royalties on commercial sales
of alliance products
• Agreement on equity investment of up to €3
million upon
achievement of a certain milestone
GlaxoSmithKline
(GSK) and Galapagos NV (Euronext & LSE: GLPG) announced
today the creation of a worldwide, multi-year, multi-programme
drug discovery and development alliance in the field of
osteoarthritis. GSK, through its recently established Center
of Excellence for External Drug Discovery (CEEDD), and Galapagos
will collaborate to deliver disease modifying drugs with
clinical Proof of Concept to GSK’s global research
and development organisation. This alliance builds upon
Galapagos’ internal target and drug discovery programmes
in osteoarthritis.
The
aim of this turn-key agreement is for Galapagos to expand
its portfolio of novel validated targets in the field of
osteoarthritis, to conduct compound screening, identify
tractable hits, pursue a number of hit-to-lead programmes,
and develop the resulting leads into candidate selection
compounds 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. Galapagos will contract a substantial part of
the activities to its service division, BioFocus.
The
focus of the alliance’s efforts will be on delivering
disease-modifying drugs with clinical Proof of Concept for
osteoarthritis to GSK’s global research and development
organisation. The overall strategy will be to identify genes
that stimulate anabolic repair processes (chondrogenesis)
and inhibit catabolic (breakdown) activity in affected joints.
Under
the terms of the agreement, Galapagos will receive an upfront
technology access fee of €4 million from GSK. Upon
successful completion of all agreed alliance programme criteria,
Galapagos stands to receive up to €65 million in success-based
milestones for a successful drug development programme.
In addition, Galapagos will receive up to double-digit royalties
on commercial sales of alliance products. Further to the
agreement, on the realisation of a defined future milestone,
GSK will make an equity investment of up to €3 million
in Galapagos.
Maxine
Gowen, Ph.D., Senior Vice President and head of GSK’s
CEEDD stated, “We are very pleased to be able to announce
the alliance with Galapagos. As there are no therapies available
that prevent or block the progression of osteoarthritis,
the potential unmet need is substantial. Through this combination
of GSK’s understanding of medical needs and Galapagos’
innovation in drug discovery, we aim to bring new medicines
to patients.”
“The
alliance announced today fits very well into our strategy
to provide turn-key drug discovery services to the biopharmaceutical
industry,” said Onno van de Stolpe, Chief Executive
Officer of Galapagos. “With this first broad alliance,
we have started to realise the strategic synergies of combining
BioFocus’ drug discovery capabilities with Galapagos’s
target discovery engine. The alliance with GSK in osteoarthritis
also serves as a strong validation of Galapagos’s
internal drug discovery programmes in bone and joint diseases.”
Galapagos’s
osteoarthritis programmes
Galapagos has ongoing osteoarthritis research programmes
and focuses on chondrocytes, which are the main cell types
in cartilage. These programmes will be the basis of the
alliance with GSK. Galapagos has identified eleven novel
targets to date that have been validated in cellular disease
models. It has progressed three of these into drug discovery
and has initiated a hit-to-lead programme on its most advanced
target. 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 characterised 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. Some 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.
About
the 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
partnerships. The CEEDD (Center of Excellence for External
Drug Discovery) was formed as further validation of GSK’s
strategy to create small, independent and accountable R&D
teams (Centers of Excellence for Drug Discovery or CEDDs).
In essence, the CEEDD will ‘virtualise’ a portion
of the GSK pipeline; namely, from Target to Clinical PoC,
by forming multiple risk-sharing/reward-sharing alliances.
Capitalising on the speed and efficiency of its partners
will allow GSK to deliver pharmaceuticals products faster
to patients.
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.
Cautionary
statement regarding forward-looking statements
Under the safe harbor provisions of the US 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 Operating and Financial Review and
Prospects in the company's Annual Report on Form 20-F for
2006.
About
Galapagos
Galapagos is a publicly traded, genomics-based drug discovery
company (Euronext Brussels, GLPG; Euronext Amsterdam, GLPGA,
London AiM: GLPG) that has drug discovery programmes based
on proprietary, novel targets in bone and joint diseases
- osteoarthritis, osteoporosis and rheumatoid arthritis.
Galapagos offers a full suite of target-to-drug discovery
products and services to pharmaceutical and biotech companies
through its division BioFocus, encompassing target discovery
and validation, and drug discovery services through to delivery
of pre-clinical candidates. In addition, BioFocus provides
adenoviral reagents for rapid identification and validation
of novel drug targets and compound libraries for screening.
Galapagos currently employs more than 220 people, including
80 PhDs, and occupies facilities in Mechelen, Belgium, Saffron
Walden, UK and Leiden, The Netherlands. Partners of Galapagos
include Amgen, AstraZeneca, BASF, Boehringer Ingelheim,
Celgene, GlaxoSmithKline, Idenix, Novartis, Organon, Roche,
Serono, Vertex, and Wyeth. More information about Galapagos
and BioFocus can be found at www.glpg.com.
GSK
Enquiries:
UK Media
enquiries:
Philip Thomson +44 20 8047 5502
Alice Hunt +44 20 8047 5502
Gwenan Evans +44 20 8047 5502
US Media enquiries:
Nancy Pekarek +1 215 751 7709
Mary Anne Rhyne +1 919 483 2839
Patricia Seif +1 215 751 7709
European Analyst/Investor enquiries:
Duncan Learmouth +44 20 8047 5540
Anita Kidgell +44 20 8047 5542
Jen Hill +44 20 8047 5543
David Mawdsley +44 20 8047 5564
US Analyst/ Investor enquiries:
Frank Murdolo +1 215 751 7002
Tom Curry +1 215 751 5419
Galapagos
NV Enquiries:
Media
enquiries:
Onno van de Stolpe, CEO +31 6 2909 8028