Bli medlem
Bli medlem

Du är här


Galapagos NV: Galapagos and MorphoSys initiate Phase 1 study in joint antibody program MOR106

Mechelen, Belgium and Martinsried/Munich, Germany; 7 April 2016 - Galapagos NV
(Euronext&NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment,
TecDAX; OTC: MPSYY) announced today that dosing of MOR106, a first-in-class
candidate human monoclonal antibody, has been initiated in healthy volunteers
in a Phase 1 study. MOR106 was jointly discovered by Galapagos and MorphoSys
under their collaboration, and has a novel mode of action with potential
application in inflammation.

The primary objective of the Phase 1 study is to evaluate the safety and
tolerability of single doses of MOR106. The study is randomized,
double-blind, placebo-controlled and conducted in a single center in at least
56 healthy volunteers in Belgium, evaluating single ascending doses (SAD)
administered as intravenous infusion. This Phase 1 study is characterized by
its adaptive design, which enables the initiation of a subsequent multiple
ascending dose (MAD) study in patients, depending on the outcome of the SAD
study in healthy volunteers.

The study's secondary objective is to characterize the pharmacokinetic profile
of MOR106 as well as monitor the occurrence of anti-drug antibodies as a
measure of immunogenicity with MOR106. Topline results of the complete
study, including the potential subsequent MAD part in patients, are expected
in the second half of 2017.

"The alliance with MorphoSys has produced a first-in-class candidate human
monoclonal antibody," said Piet Wigerinck, CSO of Galapagos. "MOR106 is the
10thGalapagos candidate with a new mode of action to be brought into the

"We are delighted to see the first antibody program from our alliance with
Galapagos entering the clinical development stage. MOR106 is MorphoSys's
fifth proprietary antibody program in clinical development and the first from
our novel Ylanthia technology platform. We are excited about the growing
value and maturity of our development pipeline. The start of this very
innovative clinical development program also reflects the high value of our
ongoing collaboration with Galapagos", commented Dr. Arndt Schottelius, Chief
Development Officer of MorphoSys AG.

About MOR106 and the antibody collaboration

MOR106 is a human IgG1 monoclonal antibody for treatment of inflammatory
diseases. MOR106 arises from the alliance initiated by Galapagos and
MorphoSys in 2008, in which both companies contribute their core technologies
and expertise. Galapagos provides the disease-related biology including
cellular assays and targets discovered using its target discovery platform.
MorphoSys contributes its Ylanthia antibody technology to generate fully
human antibodies directed against the target and contributes full CMC
development of this compound. Galapagos and MorphoSys will continue to
equally share the research and development costs, as well as all future

About MorphoSys

MorphoSys developed HuCAL, the most successful antibody library technology in
the pharmaceutical industry. By successfully applying this and other patented
technologies, MorphoSys has become a leader in the field of therapeutic
antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a
therapeuticpipelineof more than 100 human antibody drug candidates for the
treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name
just a few. With its ongoing commitment to new antibody technology and drug
development, MorphoSys is focused on making the healthcare products of
tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the
symbol MOR. For regular updates about MorphoSys,

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®,
100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are
registered trademarks of the MorphoSys Group.

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 maturing pipeline comprises Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. We have discovered and
developed filgotinib: in collaboration with Gilead we aim to bring this
JAK1-selective inhibitor for inflammatory indications to patients all over
the world. 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 440
employees, operating from its Mechelen, Belgium headquarters and facilities
in The Netherlands, France, and Croatia. More information


MorphoSys AG

Dr. Claudia Gutjahr-Löser, Head of Corporate Communications&IR
Jochen Orlowski, Associate Director Corporate Communications&IR
Alexandra Goller, Senior Manager Corporate Communications&IR
Tel: +49 (0) 89 / 899 27-404

Galapagos NV

Investors: Media:

Elizabeth Goodwin Evelyn Fox
VP IR&Corporate Communications Director Communications
+1 781 460 1784 +31 6 53 591

Galapagos forward-looking statements

This release may contain forward-looking statements, including, among other
things, statements regarding the mechanism of action and profile, and timing
of clinical trials, of MOR106. 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 MOR106 development program 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 MOR106 due to safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties (including its collaboration partner for
MOR106, MorphoSys), and estimating the commercial potential of MOR106. 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

GLPG and MorphoSys initiate Phase 1 study in MOR106


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.