• Multi-target
alliance to discover, develop, and commercialize oral small
molecule therapeutics for rheumatoid arthritis
• Janssen Pharmaceutica obtains option to license
Galapagos’ internal programs including GT418, after
completion of Phase IIa clinical studies
• Galapagos will receive €15 million in upfront
cash payments plus a first €2 million alliance milestone
payment
• Galapagos to receive yearly option fee and is eligible
for discovery, development, regulatory and sales milestones
as well as licensing fees and double digit royalties on
worldwide sales
Mechelen, Belgium; 24 October 2007 - Galapagos NV (Euronext
and LSE: GLPG) announced today that it has entered into
a worldwide multi-target alliance with Janssen Pharmaceutica
NV (‘Janssen’), a Johnson & Johnson company,
to discover and develop novel small-molecule therapeutics
for the treatment of rheumatoid arthritis (RA). Under the
alliance agreement, Janssen may select up to 12 programs
from Galapagos’ internally identified RA targets into
the alliance. Janssen receives future option rights to exclusively
license these programs. In addition, Janssen obtained an
option to the future development and commercialization of
product candidates from Galapagos’ other internal
RA programs, including its most advanced program based on
the kinase target GT418. A compound from this proprietary
drug discovery program is expected to enter Phase I clinical
trials in 2008.
Terms of the agreement
With the signing of the agreement, Janssen will make an
initial up-front cash payment of €15 million to Galapagos.
In addition, Janssen will make a €2 million milestone
payment for the selection of GT146, one of Galapagos’
advanced RA programs, into the alliance.
Under the alliance agreement, Galapagos will be responsible
for the discovery of small molecule product candidates for
those novel, validated RA targets that are chosen by Janssen.
Galapagos will develop product candidates through to Phase
IIa Proof of Concept (POC) clinical trials. During the term
of the collaboration, Galapagos is eligible to receive success-based
progress milestones from Janssen. Upon Galapagos’
achievement of POC for a product candidate, Janssen has
an exclusive option to license the product candidate from
each alliance program and will then assume full responsibility
for further clinical development and worldwide commercialization,
at its expense. For each alliance program licensed by Janssen,
contingent on discovery, development and regulatory accomplishments,
Galapagos could receive option exercise fees and milestone
payments up to €73 million, plus royalties on net sales
of each approved new RA drug.
In addition to performing research on the alliance RA targets,
Galapagos will continue to perform the R&D activities
for its internal RA programs, including its most advanced
program GT418, at its own expense up to clinical POC, subject
to an exclusive option by Janssen. Janssen’s license
option for the Galapagos drug will become exercisable upon
successful completion of Phase IIa clinical trial by Galapagos.
Should Janssen elect to exercise the option, a non-refundable
exercise fee of €60 million will be paid and thereafter
Janssen would be responsible for the development and global
commercialization, at its expense. Galapagos could be eligible
to receive up to €430 million in development and regulatory
milestones payments should more than one product be approved
for several indications in major markets. Furthermore, if
a licensed product is commercialized, Galapagos could receive
up to €346 million of one-time sales milestones upon
the achievement of predetermined sales levels and receive
double-digit royalties on worldwide sales.
“This deal will provide us with the resources to broaden
our product pipeline in RA, exploiting the full value of
our portfolio of proprietary targets. It will increase the
chances of bringing a disease modifying drug against rheumatoid
arthritis to the market,” stated Onno van de Stolpe,
CEO of Galapagos. “Janssen's vast experience in clinical
development and commercialization in rheumatoid arthritis
make Janssen the perfect partner for this program.”
Development status of Galapagos R&D program
in RA
Galapagos is a drug discovery company with pre-clinical
programs in bone and joint diseases. In the RA program,
lead compounds have shown significant disease-modifying
properties and good pharmacokinetic properties in relevant
animal models of the disease. These molecules also show
substantial protection against bone loss in the industry
standard RA animal models. The compounds target proprietary
kinase proteins that were identified using the Galapagos’
SilenceSelect target discovery platform. Based on these
results, Galapagos anticipates initiation of pre-clinical
studies later this year, with the potential of a candidate
drug entering clinical Phase I in 2008.
About RA
RA is a chronic disease, mainly affecting the joints. The
disease is characterized by inflammation of the affected
joint, which can result in chronic pain, swelling and stiffness,
and later, joint destruction and disability. RA is the most
debilitating form of arthritis and the most common inflammatory
joint disease. It is estimated that 1-2% of the population
has RA, and although it can occur at any age, onset usually
begins between the ages of 25 and 50. Women are three times
more likely than men to be affected by RA. Current market
for RA medicines is estimated at €7 billion annually;
this is expected to approach €9 billion by 2011.
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.
Galapagos webcast
& press conferences
Amsterdam
Galapagos will host an audio webcast press conference starting
at 10.30 Central European Time (CET) today at the Amsterdam
World Trade Center, Room 6, Strawinskylaan 77, 1077 XW,
Amsterdam. To participate in the conference remotely by
telephone, dial +32 2290 1608 prior to 10.25 CET. The live
audio webcast of the press conference can be accessed on
the Galapagos website at
www.glpg.com.
Brussels
Galapagos will host a video webcast press conference starting
at 15.45 CET today at the Diamant Conference & Business
Centre, Galilei Room, 80 Bd A. Reyers Ln, 1030 Brussels.
To participate in the conference remotely by telephone,
dial +32 2290 1608 prior to 15.40 CET. The live video webcast
of the press conference can be accessed on the Galapagos
website at www.glpg.com.
Both webcasts will be available for replay later today and
archived on the Galapagos website for 30 days.
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com
Media contacts for Galapagos:
Smink, Van der Ploeg &
Jongsma Financiële Communicatie
Leon Melens
Tel: +31 653 81 64 27
lmelens@spj.nl
Comfi
Gunther De Backer
Tel: +32 475 903 909
debacker@comfi.be
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
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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
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