- Exclusive global license agreement with Novartis on MOR106
- MOR106, a monoclonal antibody directed against IL-17C, will be
developed further in atopic dermatitis (AtD) and potentially other
indications
- Up-front payment of EUR 95 million (USD 111 million*) and
potential milestone payments of up to approximately EUR 850 million
(USD 1 billion*) plus royalties up to low-teens to
low-twenties
- Novartis to bear all future research, development,
manufacturing and commercialization costs related to MOR106
Mechelen,
Belgium and Planegg/Munich, Germany; 19 July 2018; 7.15 CET;
regulated information - Galapagos NV (Euronext & NASDAQ: GLPG)
and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ:
MOR) announced today that they have entered into a worldwide,
exclusive agreement with Novartis Pharma AG covering the
development and commercialization of their joint program
MOR106.
MOR106 is an investigational, fully human, IgG1
monoclonal antibody directed against the target IL-17C that was
generated in a collaboration between MorphoSys and Galapagos. Under
the terms of the agreement, the parties will cooperate to broaden
the existing development plan for MOR106 in AtD significantly.
Novartis will be exclusively holding all rights for
commercialization of any products resulting from the agreement
signed today.
Upon the signing of the agreement, all future
research, development, manufacturing and commercialization costs
for MOR106 will be borne by Novartis. This includes the ongoing
Phase 2 IGUANA trial in atopic dermatitis patients as well as a
planned Phase 1 study to evaluate the safety and efficacy of a
subcutaneous formulation of MOR106 in healthy volunteers and AtD
patients. MorphoSys and Galapagos will conduct additional trials to
support development of MOR106 in AtD. Under the terms of the
agreement, Novartis will explore the potential of MOR106 in
additional indications other than AtD.
In addition to the funding of the current and
future MOR106 program by Novartis, MorphoSys and Galapagos will
jointly receive an upfront payment of EUR 95 million (USD 111
million*). Pending achievement of certain developmental,
regulatory, commercial and sales-based milestones, MorphoSys and
Galapagos would jointly be eligible to receive significant
milestone payments, potentially amounting up to approximately EUR
850 million (USD 1 billion*), in addition to tiered royalties
on net commercial sales in the range of up to low-teens to
low-twenties. Under the terms of their 2008 agreement, Galapagos
and MorphoSys will share all payments equally (50/50).
The agreement between MorphoSys, Galapagos, and
Novartis is subject to clearance by the US antitrust authorities
under the Hart-Scott-Rodino Act, and will become effective as soon
as this condition has been met.
"This collaboration with Novartis will enable us
to accelerate and broaden the development of MOR106 beyond our
current focus on atopic dermatitis and to exploit the potential of
MOR106 to the maximum. Data from preclinical models and expression
analyses suggest that the target of MOR106 might be involved in
other diseases, which justifies expanding the development program.
We are also very pleased that we can further strengthen our
engagement in atopic dermatitis by starting additional trials
together with Galapagos, which will be fully reimbursed by
Novartis," commented Dr. Simon Moroney, Chief Executive Officer of
MorphoSys AG. "Securing a strong and committed partner for MOR106
helps the program, and also enables us to allocate more resources
elsewhere."
"It is very gratifying to announce this
collaboration with Novartis, an immunology & dermatology
powerhouse, to broadly expand the development and pave the path to
potential commercialization of MOR106. We look forward to working
with Novartis to support further progress with MOR106," said Onno
van de Stolpe, CEO of Galapagos.
MorphoSys and Galapagos concluded a Phase 1
study of MOR106 in healthy volunteers as well as in atopic
dermatitis patients in 2017. A Phase 2 clinical trial (IGUANA) in
moderate-to-severe atopic dermatitis patients was started in May
2018. MOR106 is the first publicly known human monoclonal antibody
directed against IL-17C in clinical development worldwide. MOR106
is an investigational drug candidate and its safety and efficacy
have not yet been established.
*) Converted based on current exchange rate: 1
EUR = 1.16945 USD
About MOR106 and the antibody collaboration
of Galapagos and MorphoSysMOR106 is an investigational fully
human IgG1 monoclonal antibody designed to selectively target
IL-17C, currently being developed for treatment of inflammatory
diseases. MOR106 arises from the strategic discovery and
co-development alliance between Galapagos and MorphoSys, in which
both companies contributed their core technologies and expertise.
Galapagos has provided the disease-related biology including
cellular assays and targets discovered using its target discovery
platform, specifically IL-17C for MOR106, and has performed the
clinical development of MOR106. MorphoSys has contributed its
Ylanthia antibody technology to generate fully human antibodies
directed against the target and contributed full CMC development of
this compound.
About MorphoSysMorphoSys is a late-stage
biopharmaceutical company devoted to the development of innovative
and differentiated therapies for patients suffering from serious
diseases. Based on its technological leadership in generating
antibodies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product
candidates, of which 28 are currently in clinical development. This
broad pipeline spans MorphoSys's two business segments: Proprietary
Development, in which MorphoSys invests in product candidates for
its own account, and Partnered Discovery, in which product
candidates are developed exclusively for a variety of Pharma and
Biotech partners. In 2017, Tremfya® (guselkumab), marketed by
Janssen, became the first therapeutic antibody based on MorphoSys's
proprietary technology to receive marketing approval for the
treatment of moderate-to-severe plaque psoriasis in the United
States, the European Union and Canada. MorphoSys is listed on the
Frankfurt Stock Exchange and on the U.S. stock exchange Nasdaq,
under the symbol MOR. For regular updates about MorphoSys, visit
http://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. Tremfya® is a
trademark of Janssen Biotech, Inc.
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 pulmonary 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 640
employees, operating from its Mechelen, Belgium headquarters and
facilities in the Netherlands, France, Switzerland, the United
States and Croatia. More information at www.glpg.com.
For more information, please contact:
MorphoSys AGAlexandra GollerAssociate Director Corporate
Communications & IR Jochen OrlowskiAssociate Director
Corporate Communications & IR Dr. Claudia
Gutjahr-LöserInvestor Relations Officer Tel: +49 (0) 89 /
899 27-404investors@morphosys.com |
Galapagos NVInvestors:Elizabeth GoodwinVP IR & Corporate
Communications +1 781 460 1784 Paul van der HorstDirector IR
& Business Development +31 71 750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com |
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 statements This
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
potential future payments to be made to Galapagos under a licensing
agreement for MOR106 as well as assumptions pending clearance by
U.S. antitrust 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 expectations regarding the
further development of MOR106 in moderate-to-severe atopic
dermatitis, including the intended targeting of IL-17C, and
potential additional indications, potential future payments to be
made to Galapagos under a licensing agreement for MOR106 as well as
assumptions pending clearance by U.S. antitrust authorities are
false, as well as Galapagos' expectations regarding the 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 the 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 its collaboration
partners for MOR106, MorphoSys and Novartis), 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' 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.
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