19.07.2018
MorphoSys AG DE0006632003
DGAP-Adhoc: Ad hoc: MorphoSys and Galapagos Sign Global License Agreement for MOR106 with Novartis and MorphoSys Increases its Financial Guidance for 2018
DGAP-Ad-hoc: MorphoSys AG / Key word(s): Alliance/Change in Forecast
Ad hoc: MorphoSys and Galapagos Sign Global License Agreement for MOR106
with Novartis and MorphoSys Increases its Financial Guidance for 2018
19-Jul-2018 / 07:13 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation
(EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Planegg/Munich, Germany, July 19, 2018
Ad hoc: MorphoSys and Galapagos Sign Global License Agreement for MOR106
with Novartis and MorphoSys Increases its Financial Guidance for 2018
MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX; NASDAQ: MOR)
announces today that MorphoSys and Galapagos NV have entered into a
worldwide, exclusive agreement with Novartis Pharma AG covering the
development and commercialization of their joint program MOR106. MorphoSys
furthermore announces that, in consequence of this agreement with Galapagos
and Novartis, it increases its financial guidance for the year 2018 pending
clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act.
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 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 U.S. antitrust authorities under the Hart-Scott-Rodino Act,
and will become effective as soon as this condition has been met.
In connection with the agreement and pending U.S. antitrust clearance,
MorphoSys increases its financial guidance: For 2018, MorphoSys, subject to
antitrust clearance, expects revenues in the range from EUR 67 to 72 million
(up from previously EUR 20 to 25 million) and earnings before interest and
taxes (EBIT) of EUR -55 to -65 million (up from previously EUR -110 to -120
million). R&D expenses for proprietary programs and technology development
will be in the range from EUR 87 to 97 million (previously EUR 95 to 105
million).
*) Converted based on exchange rate: 1 EUR = 1.16945 USD (as of July 18,
2018, source: www.oanda.com)
END OF AD-HOC-RELEASE
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Information and Explanation of the Issuer to this News:
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
Associate Director Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Dr. Claudia Gutjahr-Löser
Investor Relations Officer
Tel: +49 (0) 89 / 899 27-404
[email protected]
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19-Jul-2018 CET/CEST 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 Announcement DGAP News Service
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706069 19-Jul-2018 CET/CEST
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