ABBOTT PARK, Illinois and MECHELEN, Belgium, February 29, 2012 /PRNewswire/ --
Selective JAK1 inhibitor in Phase II
clinical development for rheumatoid arthritis
Abbott to retain exclusive global
commercial rights with Galapagos co-promotion
in Benelux countries
Galapagos to
receive upfront payment of $150
million, with the potential for significant milestone
payments
Galapagos to host
webcast presentation today at 4 p.m.
CET/10 a.m. Eastern
Abbott (NYSE: ABT) and Galapagos (Euronext: GLPG) announced
today that they have entered into a global collaboration to develop
and commercialize an oral, next-generation JAK1 inhibitor in Phase
II development with the potential to treat multiple autoimmune
diseases.
GLPG0634 is a highly selective JAK1 inhibitor that Galapagos is
developing for the treatment of rheumatoid arthritis (RA) and other
autoimmune diseases. The Janus kinases (JAK) are a family of
enzymes that play a key role in the signaling mechanism used by a
number of cytokines that are involved in autoimmune diseases. In
previously reported results from a 4-week Phase IIa study, GLPG0634
demonstrated efficacy measures among the best reported in RA. All
patients completed the study, and few experienced any side effects.
No anemia, change in blood pressure or lipids were observed. An
additional Phase IIa dose-range finding study with GLPG0634 is
expected to begin shortly.
"The addition of this novel, oral compound offers patients the
potential for advanced treatment options and an improved patient
experience to address RA and other autoimmune diseases," said
John Leonard, M.D., senior vice
president, global research and development, Abbott. "Abbott's
expertise in immunology, combined with a robust portfolio of
investigational treatments represents promising innovation across
several areas of medical need."
"This collaboration with Abbott, the global leader in autoimmune
diseases, is a great recognition of the value of GLPG0634. We view
Abbott to be the best partner possible to deliver a complete
clinical program and a powerful market introduction. We are excited
to continue the Phase II trials and expect to deliver to Abbott a
complete Phase II package in 2014," said Onno van de Stolpe, chief executive officer,
Galapagos. "With GLPG0634 we have proven that we can deliver from
target to clinical Proof of Concept, and we aim to do the same on
many novel target programs in our pipeline. This collaboration is
transformational for Galapagos, providing the means to progress
these innovative products into the clinic."
Under the terms of the agreement, Abbott will make an initial
upfront payment of $150 million for
rights related to the global collaboration. Upon successful
completion of the RA Phase II studies, Abbott will license the
program for a one-time fee of $200
million if the studies meet certain pre-agreed criteria.
Abbott will assume sole responsibility for Phase III clinical
development and global manufacturing. Pending achievement of
certain developmental, regulatory, commercial and sales-based
milestones, Galapagos would be eligible to receive additional
milestone payments from Abbott, potentially amounting to
$1.0 billion, in addition to tiered
double-digit royalties on net sales upon commercialization.
Galapagos retains co-promotion rights in Belgium, the
Netherlands and Luxembourg.
Webcast presentation
Galapagos will hold an audio webcast presentation for
journalists, analysts, and investors today at 4 p.m. CET/10 a.m.
Eastern US, viewable at http://www.glpg.com.
Call numbers:
Belgium 0800 50747
Netherlands 0800 265 8528
US 1-877-941-6009
Other countries +32-2290-1608 or +31-20-794-8504
Galapagos Forward-Looking
Statements
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 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,
unless required by law or regulation.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size
biotechnology company specialized in the discovery and development
of small molecule and antibody therapies with novel
modes-of-action. The Company is progressing GLPG0634 through Phase
II and has one of the largest pipelines in biotech, with four
programs in development and over 50 discovery programs. The
Galapagos Group has about 800 employees and operates facilities in
six countries, with global headquarters in Mechelen, Belgium. More info at:
http://www.glpg.com
Abbott Forward-Looking Statements
Some statements in this news release
may be forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. Abbott cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Economic,
competitive, governmental, technological and other factors that may
affect Abbott's operations are discussed in Item 1A, "Risk
Factors," to our Annual Report on Securities and Exchange
Commission Form 10-K for the year ended Dec.
31, 2011, and are incorporated by reference. Abbott
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs approximately 91,000
people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on
the company's Web site at http://www.abbott.com.