-- Genmab to receive USD 25 million milestone payment from Janssen
-- Milestone triggered by progress in the Phase III study of daratumumab in
combination with lenalidomide and dexamethasone in relapsed or refractory
Copenhagen, Denmark; July 7, 2014 -- Genmab A/S (OMX: GEN) announced today it
has reached the third milestone in its daratumumab collaboration with Janssen
Biotech, Inc. ("Janssen"). The USD 25 million milestone payment was triggered
by progress in the ongoing Phase III study of daratumumab in combination with
lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for
the treatment of relapsed or refractory multiple myeloma.
"Since our partnership with Janssen began in October 2012, we have made very
significant progress with the development of daratumumab, announcing five new
clinical studies and reporting data from two ongoing studies in multiple
myeloma. Today's milestone marks another important step, as patients are now
receiving treatment in the first Phase III study of daratumumab in multiple
myeloma," 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 May 1, 2014.
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 for the
treatment of patients with multiple myeloma who have received at least three
prior lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide
license to develop 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 currently has one
marketed antibody, Arzerra(R) (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications, a clinical pipeline with both late and early
stage programs, and an innovative pre-clinical pipeline. Genmab's technology
base consists of validated and proprietary next generation antibody
technologies - the DuoBody(R) platform for generation of bispecific antibodies,
and the HexaBody(TM) platform which creates effector function enhanced antibodies.
Genmab's deep antibody expertise is expected to provide a stream of future
product candidates. Partnering of selected 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
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
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. 34
CVR no. 2102 3884
1260 Copenhagen K