Serono and Genmab Announce Global Development and Commercialization Agreement for Humax-CD4
August 18 2005 - 2:00AM
PR Newswire (US)
HuMax-CD4 Currently in Phase III Clinical Trial for Cutaneous
T-Cell Lymphoma and Phase II Clinical Trial for Non-Cutaneous
T-Cell Lymphoma GENEVA, Switzerland and COPENHAGEN, Denmark, August
18 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) and
Genmab A/S (CSE:GEN) announced today an agreement under which
Genmab has granted Serono exclusive worldwide rights to develop and
commercialize Genmab's HuMax-CD4. HuMax-CD4 is a fully human
monoclonal antibody in development for the treatment of cutaneous
and non-cutaneous T-cell lymphomas. It is currently being evaluated
in a pivotal Phase III clinical trial for cutaneous T-cell lymphoma
(CTCL) under the US Food and Drug Administration's Special Protocol
Assessment process and has Fast Track designation from the FDA.
HuMax-CD4 is also being studied in a Phase II trial for
non-cutaneous T-cell lymphoma (NCTCL). HuMax-CD4 is directed
against the CD4 antigen and causes depletion of certain T-cells
through antibody-dependent cellular cytotoxicity. Under the terms
of the agreement, Genmab will receive a license fee of USD 20
million, and Serono will make a USD 50 million investment in Genmab
common stock, at a premium to the market price. Genmab may receive
up to USD 215 million in total payments, including the initial
license fee and equity purchase, milestone payments for regulatory
submissions and approvals of HuMax-CD4 in CTCL and NCTCL in the US,
Europe and Japan, and payments based on the achievement of certain
sales milestones. Genmab will be entitled to receive royalties on
global sales of HuMax-CD4. Serono will be responsible for all
future development costs for HuMax-CD4 and for future manufacturing
of the product. Genmab will continue to conduct the ongoing
clinical trials as described above. "Serono's proficiency in
bringing biotechnology products to market as well as their
established presence in highly specialized dermatology clinics,
which play a significant role in the diagnosis and treatment of
CTCL, makes the company an excellent strategic partner," said Lisa
N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are
committed to building a strong oncology pipeline through
partnerships with leading companies such as Genmab, and through our
own internal research," said Ernesto Bertarelli, Chief Executive
Officer of Serono. "HuMax-CD4 is an important addition to Serono's
oncology portfolio, which now consists of four different
clinical-stage products being investigated across a broad range of
indications." Simultaneously with this release, Genmab will publish
a separate stock exchange release containing more information
regarding the placement of Genmab shares to Serono, which is made
in direct connection with the Global Development and
Commercialization Agreement regarding HuMax-CD4. About CTCL and
NCTCL Cutaneous T-cell lymphomas (CTCL) are a group of lymphomas
characterized by abnormal accumulation of malignant T-cells in the
skin, potentially resulting in the development of rashes, plaques
and tumors. The most common types of CTCL include mycosis fungoides
(MF) and Sezary syndrome (SS). CTCL result from errors in the
production of T-lymphocytes or transformation of T-lymphocytes into
malignant cells. Abnormal, uncontrolled growth and multiplication
of malignant T-lymphocytes result in accumulation of these
lymphocytes in the skin and may in some cases spread and affect the
lymph nodes and other body tissues and organs, resulting in
life-threatening complications. Non-cutaneous T-cell lymphomas
(NCTCL) are defined by highly malignant disease, which has
localized to the lymph nodes even at the earliest stage of
presentation, and include angioimmunoblastic T-cell lymphoma,
anaplastic large cell lymphoma (ALCL) and unspecified peripheral
T-cell lymphoma. NCTCL is characterized by aggressive progression
with average survival time of approximately two years. About
HuMax-CD4 (Zanolimumab) HuMax-CD4 is a human monoclonal antibody
currently in Phase III development for cutaneous T-cell lymphoma
(CTCL) and in Phase II for non-cutaneous T-cell lymphoma. These
types of lymphomas express the CD4 receptor, which is the target of
HuMax-CD4. In April 2005, Genmab and the United States Food and
Drug Administration (FDA) reached an agreement on the design of its
pivotal study protocol for HuMax-CD4 to treat CTCL under the
Special Protocol Assessment process (SPA). The pivotal study will
include patients with mycosis fungoides (MF) who are refractory to
or intolerant of Targretin(R) and one other standard therapy, and
will treat a total of 88 patients. In March 2004, Genmab announced
that HuMax-CD4 had been designated a Fast Track Product by the US
Food and Drug Administration (FDA). This designation covers
patients with CTCL for whom no available therapy exists, i.e. have
failed at least two systemic treatment regimens. HuMax-CD4 for the
treatment of MF has also been granted Orphan Drug status in the US
and Europe. Genmab forward-looking statements This press release
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 product discovery and
development, 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. Genmab is not under an
obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in
relation to actual results, unless this is required by law. Serono
forward-looking statements Some of the statements in this press
release are forward looking. Such statements are inherently subject
to known and unknown risks, uncertainties and other factors that
may cause actual results, performance or achievements of Serono
S.A. and affiliates to be materially different from those expected
or anticipated in the forward-looking statements. Forward-looking
statements are based on Serono's current expectations and
assumptions, which may be affected by a number of factors,
including those discussed in this press release and more fully
described in Serono's Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission on March 16, 2005. These
factors include any failure or delay in Serono's ability to develop
new products, any failure to receive anticipated regulatory
approvals, any problems in commercializing current products as a
result of competition or other factors, our ability to obtain
reimbursement coverage for our products, the outcome of government
investigations and litigation and government regulations limiting
our ability to sell our products. Serono has no responsibility to
update the forward-looking statements contained in this press
release to reflect events or circumstances occurring after the date
of this press release. About Genmab A/S Genmab A/S is a
biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases.
Genmab has numerous products in development to treat cancer,
infectious disease, rheumatoid arthritis and other inflammatory
conditions, and intends to continue assembling a broad portfolio of
new therapeutic products. At present, Genmab has multiple
partnerships to gain access to disease targets and develop novel
human antibodies including agreements with Roche and Amgen. A broad
alliance provides Genmab with access to Medarex, Inc.'s array of
proprietary technologies, including the UltiMAb(R) platform for the
rapid creation and development of human antibodies to virtually any
disease target. Genmab has operations in Copenhagen, Denmark,
Utrecht, the Netherlands, and Princeton, New Jersey in the US. For
more information about Genmab, visit http://www.genmab.com/. About
Serono Serono is a global biotechnology leader. The Company has
eight biotechnology products, Rebif(R), Gonal-f(R), Luveris(R),
Ovidrel(R )/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology.
Currently, there are approximately 30 ongoing development projects.
In 2004, Serono achieved worldwide revenues of US$2,458.1 million,
and a net income of US$494.2 million, making it the third largest
biotech company in the world. Its products are sold in over 90
countries. Bearer shares of Serono S.A., the holding company, are
traded on the virt-x (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA). http://www.serono.com/
http://www.seronousa.com/ DATASOURCE: Serono International S.A.
CONTACT: Corporate Media Relations: Tel: +41-22-739-36-00, Fax:
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