19.07.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys and Galapagos Sign Global License Agreement for MOR106 with Pharma Partner
DGAP-News: MorphoSys AG / Key word(s): Alliance/Change in Forecast
MorphoSys and Galapagos Sign Global License Agreement for MOR106 with Pharma
Partner (news with additional features)
19.07.2018 / 07:15
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, and Mechelen, Belgium, July 19, 2018
MorphoSys and Galapagos Sign Global License Agreement for MOR106 with Pharma
Partner
- 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
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) and
Galapagos NV (Euronext & NASDAQ: GLPG) 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 (AtD) 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 to 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 agreement
from 2008, 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 are thrilled to
work 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 exchange rate: 1 EUR = 1.16945 USD (as of July 18,
2018, source: www.oanda.com)
About MOR106 and the antibody collaboration of Galapagos and MorphoSys
MOR106 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 MorphoSys
MorphoSys 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(R) (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(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R),
arYla(R),
Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R)
and LanthioPep(R) are registered trademarks of the MorphoSys Group.
Tremfya(R)
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.
MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the outlicensing expectations in
connection with MOR106 and 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 MorphoSys under a licensing agreement for MOR106 as
well as assumptions pending clearance by U.S. antitrust authorities. 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 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 MorphoSys under a licensing agreement for MOR106 as
well as assumptions pending clearance by U.S. antitrust authorities are
false as well as the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements, MorphoSys' reliance on collaborations with
third parties and other risks indicated in the risk factors included in
MorphoSys's Registration Statement on Form F-1 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.
For more information, please contact:
MorphoSys AG Alexandra Goller Galapagos NV Investors: Elizabeth
Associate Director Corporate Goodwin VP IR & Corporate
Communications & IR Jochen Communications +1 781 460 1784
Orlowski Associate Director Paul van der Horst Director IR &
Corporate Communications & IR Dr. Business Development +31 71 750
Claudia Gutjahr-Löser Investor 6707 [email protected] Media: Evelyn Fox
Relations Officer Tel: +49 (0) 89 Director Communications +31 6 53
/ 899 27-404 591 999 [email protected]
[email protected]
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Additional features:
Document: http://n.eqs.com/c/fncls.ssp?u=PKKBCLLQYF
Document title: Media Release
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19.07.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: [email protected]
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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706099 19.07.2018
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