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Genmab — Regulatory Filings 2014
Mar 26, 2014
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Regulatory Filings
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Ad-hoc | 26 March 2014 23:46
Genmab Reaches $22 Million Milestone in Daratumumab Collaboration with Janssen
Genmab A/S
26.03.2014 23:46
Dissemination of a Adhoc News, transmitted by DGAP - a company of EQS Group
AG.
The issuer is solely responsible for the content of this announcement.
Company Announcement
-- Genmab to receive $22 million milestone payment from Janssen
-- Milestone triggered by progress in the Phase II study of daratumumab in
double refractory multiple myeloma
Copenhagen, Denmark; March 26, 2014 - Genmab A/S (OMX: GEN) announced today it
has reached the second milestone in its daratumumab collaboration with Janssen
Biotech, Inc. ('Janssen'). The $22 million milestone payment was triggered by
progress in the ongoing Phase II study of daratumumab in multiple myeloma
patients who have received at least three different lines of therapy, including
both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who
are double refractory to a PI and an IMiD. This is the same indication for
which daratumumab was granted Breakthrough Therapy Designation from the FDA in
May 2013.
'The daratumumab development program continues to move forward successfully
under our productive collaboration with Janssen and we are pleased to reach
this second milestone in the agreement,' said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
The milestone payment is included in Genmab's 2014 financial guidance published
on March 4, 2014.
About daratumumab
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing
activity. Daratumumab is in clinical development for multiple myeloma (MM).
Daratumumab targets the CD38 molecule which is highly expressed on the surface
of multiple myeloma cells. Daratumumab may also have potential in other cancers
on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic
lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute
myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab
has been granted Breakthrough Therapy Designation from the US FDA. In August
2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to
develop, manufacture and commercialize daratumumab.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company's first marketed
antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future product
candidates. Partnering of innovative product candidates and technologies is a
key focus of Genmab's strategy and the company has alliances with top tier
pharmaceutical and biotechnology companies. For more information visit
www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]
This Company Announcement contains forward looking statements. The words
'believe', 'expect', 'anticipate', 'intend' and 'plan' and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to the
outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment in
relation to our business area and markets, our inability to attract and retain
suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our products obsolete,
and other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmab's most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to
confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); the
Y-shaped Genmab logo(r); Genmab in combination with the Y-shaped Genmab logo(tm);
the DuoBody logo(tm); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(tm)
and UniBody(r). Arzerra(r) is a registered trademark of the GSK group of companies.
Company Announcement no. 15
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
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News Source: NASDAQ OMX
26.03.2014 DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
Language: English
Company: Genmab A/S
Dänemark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
End of Announcement DGAP News-Service