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 Gilead
At 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 Gilead
In 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 Galapagos
Galapagos (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.
Contact
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Galapagos
forward-looking statements
This 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.
Galapagos exercises option
filgotinib
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Galapagos NV via Globenewswire
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