Galapagos webcast presentation of the
partnership to be held on 17 December, 17.00 CET/11 AM EST/8 AM
PST, +1 646 254 3361 access code 5852445,
more call number info further down
Galapagos NV (Euronext & NASDAQ: GLPG) and Gilead Sciences,
Inc. (NASDAQ: GILD) today announced that the companies have entered
into a global partnership for the development and commercialization
of the JAK1-selective inhibitor filgotinib for inflammatory
indications. Galapagos will receive an upfront payment of
$725 million consisting of a license fee of $300 million and a $425
million equity investment in Galapagos. In addition,
Galapagos is eligible for payments of up to $1.35 billion in
milestones, with tiered royalties starting at 20% and a profit
split in co-promotion territories.
Phase 2 trial data show that filgotinib has the
potential to be an effective and well-tolerated oral therapy for
patients with rheumatoid arthritis (DARWIN studies) and Crohn's
disease (FITZROY study). The companies will start Phase 3
trials in RA and Crohn's in 2016 pending the successful outcome of
discussions with regulatory authorities.
"We are excited about the potential of
filgotinib in RA and other diseases with a strong partner like
Gilead, which shares our goal of rapidly delivering these therapies
to patients," said Onno van de Stolpe, Chief Executive Officer of
Galapagos. "Furthermore, we look forward to the perspective
of working together worldwide across other possible
indications. The co-development and co-promotion aspects of
this collaboration bring us into the next phase of the company's
evolution."
"This partnership represents an opportunity to
add complementary clinical programs to our growing inflammation
research and development efforts," said Norbert Bischofberger, PhD,
Gilead's Executive Vice President, Research and Development and
Chief Scientific Officer. "We look forward to working with
Galapagos to advance this program forward as quickly as
possible."
Under the terms of the agreement, the companies
will collaborate jointly on the global development of filgotinib
starting with the initiation of Phase 3 trials in RA.
Galapagos will co-fund 20 percent of global development activities
and Gilead will be responsible for manufacturing and worldwide
marketing and sales activities. Galapagos has the option to
co-promote filgotinib in the UK, Germany, France, Italy, Spain,
Belgium, the Netherlands and Luxembourg, in which case the
companies will share profits equally. If Galapagos exercises
its option to co-promote in Belgium, the Netherlands or Luxembourg,
it will also book sales in these countries.
Galapagos will receive an upfront license fee of
$300 million and Gilead will make a $425 million equity investment
in Galapagos by subscribing for shares at a price of €58 per share,
which represents a 20% premium as compared to the average share
price over the last 30 days. After the issuance of the
shares, Gilead will own approximately 15% of the outstanding share
capital of Galapagos, depending on the $/€ exchange rate at
closing. Galapagos is eligible to receive further development,
regulatory and commercial milestone payments up to $1.35 billion,
plus tiered royalties on global sales starting at 20%, with the
exception of the co-promotion territories where profits will be
shared equally.
This transaction has been approved by the boards
of both companies, and is subject to customary closing conditions
and clearance under the Hart-Scott Rodino Antitrust Improvements
Act.
Galapagos Conference Call and Webcast
Galapagos will conduct a conference call open to the public on 17
December 2015 at 17:00 Central European Time/11 AM Eastern US/8 AM
Pacific US, which will also be webcast. To participate in the
conference call, please call one of the following numbers ten
minutes prior to commencement:
CODE:
5852445 United Kingdom:
+44(0)20 3427 1915 or 0800 279 4977 France:
+33(0)1 76 77 22 25 or 0805 631 580 Belgium:
+32(0)2 402 3092 or 0800 58033 United States:
+1 646 254 3361 or 1877 280 2296 The Netherlands:
+31(0)20 713 2789 or 0800 020 2576
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to access the live
audio webcast. An archived webcast and PDF of the slides will
be available on the Galapagos website later in the day.
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. Our pipeline comprises three Phase 2,
three Phase 1, five pre-clinical, and 20 discovery studies in
cystic fibrosis, inflammation, fibrosis, osteoarthritis and other
indications. We are 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 400 employees, operating from
its Mechelen, Belgium headquarters and facilities in The
Netherlands, France, and Croatia. More information at
www.glpg.com.
About Gilead Gilead Sciences is a
biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical
need. The company's mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Gilead has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
Galapagos Contacts
Investors:
Media: Elizabeth
Goodwin
Evelyn Fox VP IR & Corporate
Communications
Director Communications Tel: +1 781 460
1784
Tel: +31 6 53 591 999 E-mail:
ir@glpg.com
E-mail: communications@glpg.com
Gilead Contacts
Investors:
Media: Patrick O'Brien
Michele Rest
Tel: +1 650 522
1936
Tel: +1 650 577 6935 E-mail:
Patrick.O'Brien@gilead.com
E-mail: michele.rest@gilead.com
Galapagos Forward-Looking Statements This release may
contain forward-looking statements, including, among other things,
statements regarding the expected timing of closing of the
partnership with Gilead, the amount and timing of potential future
milestone and/or royalty payments by Gilead, statements regarding
the expected timing, design and readouts of ongoing and planned
clinical trials with filgotinib in rheumatoid arthritis (Phase
3) and Crohn's disease (Phase 2), the future development,
regulatory approval and commercialization of filgotinib and the
commercial potential of filgotinib. Galapagos cautions the
reader that forward-looking statements are not guarantees of future
performance. In particular it should be noted that the
positive results of the DARWIN 1 and DARWIN 2 Phase 2B and FITZROY
Phase 2 trials of filgotinib may not be indicative of future
results, either on a stand-alone basis or as part of a combination
therapy. 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 the inherent
uncertainties associated with competitive developments, clinical
trial and product development activities and regulatory approval
requirements (including that data from Galapagos' ongoing and
planned clinical research programs with filgotinib may not support
registration or further development of filgotinib due to safety,
efficacy or other reasons), any applicable antitrust clearance
requirements, Galapagos' reliance on collaborations with third
parties (including its collaboration partner, Gilead), and
estimating the commercial potential of Galapagos' product
candidates. 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' prospectus filed with the SEC on 14 May 2015 and
subsequent 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.
Gilead Forward-Looking Statement This
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including risks that the parties will be unable to develop and
commercialize filgotinib for the treatment of rheumatoid arthritis
or any other indications; the expected timing of the completion of
the transaction; and the ability of the parties to complete the
transaction considering the transaction is subject to closing
conditions. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not
to rely on these forward-looking statements. These and other
risks are described in detail in Gilead's Quarterly Report on Form
10-Q for the quarter ended September 30, 2015, as filed with the
U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation to update any such forward-looking
statements.
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