20.15 CET; regulated information - MorphoSys AG
(FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) and
Galapagos NV (Euronext & NASDAQ: GLPG) today announced the end
of the clinical development program of MOR106 in atopic dermatitis.
The joint decision of all three involved parties, Galapagos NV,
MorphoSys AG and Novartis Pharma AG, was based on an interim
analysis for futility that was performed in the Phase 2 IGUANA
trial. The analysis detected a low probability to meet the primary
endpoint of the study, defined as the percentage change in the
eczema area and severity index (EASI) score. The decision was based
on a lack of efficacy and not on safety concerns.
The clinical development program of MOR106 in
atopic dermatitis included the two Phase 2 studies IGUANA and
GECKO, as well as a Phase 1 bridging study for subcutaneous
formulation and a Japanese ethno-bridging study. All studies in
atopic dermatitis will be ended. Parties will explore the future
strategy with MOR106.
MOR106 was jointly discovered by Galapagos and
MorphoSys. In July 2019, Galapagos and MorphoSys entered into an
exclusive worldwide development and commercialization collaboration
with Novartis with respect to MOR106.
“We are obviously disappointed with this result
with MOR106 in atopic dermatitis. Together with our collaboration
partners, we will explore the future strategy with MOR106,” said Dr
Piet Wigerinck, Chief Scientific Officer of Galapagos.
“Unfortunately, the results from the interim
analysis for futility do not support the continuation of the
current clinical development of MOR106 in atopic dermatitis” said
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys.
“While we are clearly disappointed, we remain committed to the
development of MorphoSys’ proprietary early and late-stage drug
candidates, such as MOR202 and especially tafasitamab.”
About MOR106MOR106 was generated using
MorphoSys’s Ylanthia antibody platform and is based on a target
discovered by Galapagos. IL-17C is a cytokine expressed
preferentially in the skin and which has been implicated in dermal
inflammation and shown to be distinct from other members of the
IL-17 cytokine family. MOR106 is the first publicly known human
monoclonal antibody directed against IL-17C in clinical development
worldwide. MOR106 is an investigational drug and its safety and
efficacy have not yet been established. Novartis Pharma AG owns the
worldwide, exclusive license for the development and
commercialization of MOR106 under an agreement with MorphoSys and
Galapagos which became effective on September 10, 2018.
About MorphoSys:MorphoSys (FSE & NASDAQ:
MOR) is a clinical-stage biopharmaceutical company dedicated to the
discovery, development and commercialization of exceptional,
innovative therapies for patients suffering from serious diseases.
The focus is on cancer. Based on its leading expertise in antibody,
protein and peptide technologies, MorphoSys, together with its
partners, has developed and contributed to the development of more
than 100 product candidates, of which 29 are currently in clinical
development. In 2017, Tremfya®, marketed by Janssen for the
treatment of plaque psoriasis, became the first drug based on
MorphoSys’s antibody technology to receive regulatory approval. The
Company’s most advanced proprietary product candidate, tafasitamab,
has been granted U.S. FDA breakthrough therapy designation for the
treatment of patients with relapsed/refractory diffuse large B-cell
lymphoma (DLBCL). Headquartered near Munich, Germany, the MorphoSys
group, including the fully owned U.S. subsidiary MorphoSys US Inc.,
has approximately 330 employees. More information at
https://www.morphosys.com.
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) discovers and develops small molecule medicines with
novel modes of action, three of which show promising patient
results and are currently in late-stage development in multiple
diseases. Galapagos’ pipeline comprises Phase 3 through to
discovery programs in inflammation, fibrosis, osteoarthritis and
other indications. The Company’s ambition is to become a leading
global biopharmaceutical company focused on the discovery,
development and commercialization of innovative medicines. More
information at www.glpg.com.
MorphoSys forward looking statementsThis
communication contains certain forward-looking statements
concerning the MorphoSys group of companies, including the
expectations in connection with the clinical development of
proprietary assets. The forward-looking statements contained herein
represent the judgment of MorphoSys as of the date of this release
and involve known and unknown risks and uncertainties, which might
cause the actual results, financial condition and liquidity,
performance or achievements of MorphoSys, 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 MorphoSys' 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 expectations in connection with the clinical development
of proprietary assets, MorphoSys' reliance on collaborations with
third parties and other risks indicated in the risk factors
included in MorphoSys’s Annual Report on Form 20-F and other
filings with the US Securities and Exchange Commission. 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. MorphoSys 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.
This press release contains inside information
within the meaning of Regulation (EU) No 596/2014 of the European
Parliament and of the Council of 16 April 2014 on market abuse
(market abuse regulation).
Galapagos forward looking statementsThis release
may contain forward-looking statements, including, among other
things, statements regarding the mechanism of action and profile
of, and timing and results of clinical trials with, and potential
commercialization of MOR106; statements regarding the collaboration
between Galapagos, MorphoSys and Novartis; statements regarding
payments under such collaboration agreement; and statements
regarding interactions with regulatory authorities. 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 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 programs may not support registration or further
development of MOR106 due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties (including
our collaboration partners for MOR106, Novartis and MorphoSys), and
estimating the commercial potential of the MOR106 development
program. 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.
For more information, please contact:
MorphoSys AGDr. Sarah FakihHead of Corporate
Communications & IR Tel: +49 (0) 89 / 899
27-26663Sarah.Fakih@morphosys.com Dr. Julia NeugebauerDirector
Corporate Communications & IR Tel: +49 (0) 89 / 899
27-179Julia.Neugebauer@morphosys.com Dr. Verena KupasManager
Corporate Communications & IR Tel: +49 (0) 89 / 899
27-26814Verena.Kupas@morphosys.com
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Galapagos NVInvestors:Elizabeth
GoodwinVP Investor Relations +1 781 460 1784 Sofie Van
GijselDirector IR +32 485 191415ir@glpg.com
Media:Carmen VroonenSenior Director Communications
& Public Affairs+32 473 824 874 Evelyn
FoxDirector Communications +31 6 53 591 999 communications@glpg.com
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