Equity lock-up and standstill arrangement between the
companies to expire on 31 December 2017
Mechelen, Belgium; 14 December 2017; 22.01
CET - Galapagos NV (Euronext & NASDAQ: GLPG) announced
today the decision to opt-in on the co-promotion of filgotinib with
collaboration partner Gilead Sciences in eight European countries,
should filgotinib be approved for commercial sale.
Galapagos assumes 35% of the co-promotion
efforts in Germany, France, Italy, Spain, the United Kingdom, the
Netherlands, Belgium, and Luxembourg. The parties will share
equally in the net profit and net losses in these territories. In
the markets in Belgium, the Netherlands, and Luxembourg, Galapagos
will book the sales. Outside the co-promotion territories,
Galapagos will be eligible to receive tiered royalty percentages
ranging from 20-30% on global net sales of filgotinib.
"With this decision, Galapagos takes the next
step in its development and moves towards the commercial phase. We
and Gilead are preparing the potential launch of filgotinib, during
which time Galapagos plans to build a commercial infrastructure to
co-promote with Gilead. It is gratifying that, after all the early
years of innovation, Galapagos is now preparing to commercialize
the first asset arising from our discovery efforts," said CEO and
founder of Galapagos, Onno van de Stolpe.
Filgotinib is an investigational therapy, and
its safety and efficacy have not been established. Filgotinib is
currently being evaluated in Phase 3 studies in rheumatoid
arthritis, Crohn's disease, and ulcerative colitis, and in Phase 2
studies in small bowel Crohn's disease, fistulizing Crohn's
disease, Sjögrens, ankylosing spondylitis, psoriatic arthritis,
cutaneous lupus erythematosus, uveitis, and lupus membranous
nephropathy.
Update on lock-up and standstill arrangement
with GileadAt the closing of the collaboration agreement
transaction in January 2016, Gilead made a $425
million (or €392 million) equity investment in Galapagos, as a
result of which Gilead acquired 6,760,701 ordinary shares of
Galapagos, representing 13.27% of the currently outstanding share
capital of Galapagos. Further to this collaboration agreement, the
parties agreed to a lock-up and standstill arrangement. The lock-up
and standstill arrangement will expire on 31 December 2017.
About the collaboration agreement with
GileadIn December 2015, Galapagos entered into a global
collaboration agreement with Gilead to develop and commercialize
filgotinib for the treatment of inflammatory indications. Galapagos
received an upfront payment of $725 million consisting of a
one-time license fee in the amount of $300 million and a $425
million equity investment. In addition, Galapagos will be eligible
to receive development and regulatory milestone-based payments of
up to $755 million, of which Galapagos has already received $70
million, and sales-based milestone payments of up to $600 million.
Galapagos will be eligible to receive tiered royalty percentages
ranging from 20% to 30% on global net sales of licensed products.
Galapagos will assume a portion of the co-promotion effort in
Germany, France, Italy, Spain, the United Kingdom, the Netherlands,
Belgium, and Luxembourg and will share equally in the net profits
and net losses in these territories instead of receiving royalties
in those territories during the period of co-promotion. Under the
terms of the collaboration, Gilead is primarily responsible for
development and for seeking regulatory approval of the licensed
product. Galapagos is responsible for co-funding 20% of development
costs through to regulatory approval.
About GalapagosGalapagos (Euronext & NASDAQ: GLPG) is
a clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Galapagos' pipeline comprises Phase 3 through to discovery
programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis
and other indications. Our target discovery platform has delivered
three novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic fibrosis and atopic
dermatitis. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service subsidiary
Fidelta, has approximately 578 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands,
France, and Croatia. More information at www.glpg.com.
ContactInvestors:Elizabeth GoodwinVP IR &
Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 71
750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Galapagos forward-looking statementsThis
release may contain forward-looking statements pertaining to
Galapagos, including, among other things, statements regarding its
collaboration with Gilead, including royalties and milestone
payments, profit and loss sharing, and development plans and
related costs, or regarding the timing, progress and/or results of
clinical studies with, and plans related to, filgotinib, including
commercialization plans. Galapagos cautions the reader that
forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos' expectations
regarding its filgotinib development programs may be incorrect, the
inherent uncertainties associated with competitive developments,
clinical trial and product development activities and regulatory
approval requirements (including that data from Galapagos' ongoing
clinical research program may not support registration or further
development of filgotinib due to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties
(including its collaboration partner for filgotinib, Gilead), and
estimating the commercial potential of filgotinib. A further list
and description of these risks, uncertainties and other risks can
be found in Galapagos' Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos' most recent annual
report on Form 20-F filed with the SEC and other filings and
reports filed by Galapagos with the SEC. 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 or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
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