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About GenmabLegal Notice © 2008 Genmab A/S
About Genmab » Partnerships Genmab’s ability to quickly convert interesting disease targets into
antibody products has attracted numerous partners. To maximize the value of
our integrated human antibody development capabilities, Genmab is forming
collaborations with other biotechnology and pharmaceutical companies to
co-develop antibody products to novel disease targets.
Pursuant to a series of licensing arrangements commencing in May 1999, we
obtained exclusive worldwide rights to Amgen's patent estate relating to antibodies to IL15,
a promising target in the area of inflammation, and the IL15 receptor, which
is found on a number of tumor types. In October 2001, this sub-licensing
arrangement was replaced by a direct license from Amgen. Amgen retained an
exclusive commercialization option for the products through Phase II. In July
2003, Amgen exercised its commercialization options for both the HuMax-IL15™
antibody program (now AMG 714) and the IL15 receptor program. In addition,
Amgen has expanded its agreement with Genmab to include a new antibody
program on an additional disease target.
Under the terms of the expanded and amended agreement, if products to all
three targets are successfully commercialized and certain sales levels are
achieved, Genmab will be entitled to receive up to USD 135.5 million in
license fees and milestone payments. Genmab is also entitled to royalties on
commercial sales instead of the profit sharing designated in the original
agreement. In connection with the option exercise, Genmab received the first
milestone payment of USD 10 million for products targeting the IL15 pathway.
Amgen will be responsible for all future development costs for products
targeting the IL15 pathway and Genmab will participate in the pre-clinical
development of the new program. In September 2003, Genmab achieved the second
milestone by delivering a human antibody targeting the IL15 receptor. The
milestone released a USD 500,000 payment to Genmab from Amgen.
Amgen has informed Genmab that it would discontinue development of AMG 714
in psoriasis and rheumatoid arthritis based on disappointing results from
recent clinical studies. Amgen is exploring options to maximize the value
of this asset, but at this time, no further internal development of a lead
indication is planned.
In May 2002, we entered into a collaboration with ACE BioSciences, a
privately owned company based in Denmark, to develop new antibody products to
treat infectious disease. In November 2003, Genmab and ACE
BioSciences announced plans to develop an antibody therapeutic product
with the potential to treat fungal infections. The antibody will be directed
against a novel target on Aspergillus fumigatus. This fungus can cause life
threatening infections in patients whose immune systems are compromised, for
example, cancer patients receiving chemotherapy. Genmab and ACE
BioSciences will collaborate on the research, development and
commercialization of the new antibody products and will share development
costs and revenues generated from out-licensing or sales of these products
equally.
In February 2006, we acquired exclusive worldwide rights to develop
therapeutics based upon a series of angiogenesis targets identified by
Bionomics,
an ASX listed biotechnology company based in
Australia. Under the terms of the deal, Bionomics receives an upfront
fee and additional fees upon the first target achieving specified
preclinical and clinical milestones. Bionomics will also receive
milestone payments and royalties on product sales for each product that
reaches the market. The agreement is the outcome of an earlier
collaboration to create and develop fully human antibodies to angiogenesis
targets identified by Bionomics.
In November 2006, Genmab licensed rights to the MIF receptor target from Cytokine PharmaSciences. Genmab intends to develop therapeutic human antibodies to the target. Details of the agreement have not been disclosed.
In December 2006, Genmab announced a worldwide agreement with GlaxoSmithKline (GSK)
to co-develop and commercialize ofatumumab (HuMax-CD20®). Ofatumumab is
in late stage development for CD20 positive B-cell chronic lymphocytic
leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and rheumatoid
arthritis (RA) and is in Phase II front line studies for CLL and NHL.
Furthermore, Phase II studies in diffuse large B-cell lymphoma (DLBCL) and
relapsing remitting multiple sclerosis (RRMS) are ongoing.
Under the terms of the agreement, Genmab received a license fee of DKK 582
million (approx. $102 million), and GSK invested DKK 2,033 million
(approx. $357 million) to purchase 4,471,202 ordinary shares of Genmab. The
total potential value of this agreement, in the event of full commercial
success, in cancer and various autoimmune and inflammatory diseases, could
exceed DKK 12.0 billion (approx. $2.1 billion), including the initial
license fee and equity purchase, milestone payments, totaling DKK 9.0
billion (approx. $1.6 billion) and expected development, commercial
manufacturing and commercialization costs.
In addition, Genmab will be entitled to receive tiered double digit
royalties on global sales of ofatumumab.
GSK will receive an exclusive worldwide license to ofatumumab as well as
any other antibodies with affinity for the CD20 antigen which Genmab may
develop. GSK will also have an exclusive option to a CD20 UniBody® to be
developed in collaboration with Genmab. GSK and Genmab will co-develop
ofatumumab. Genmab will be responsible for development costs until 2008,
including costs of the two ongoing late stage oncology studies, after which
development costs will be shared equally between GSK and Genmab. GSK will
be solely responsible for the manufacturing and commercialization of
ofatumumab.
Under the original terms of the agreement, Genmab had an option to
co-promote ofatumumab in a targeted oncology setting in the US and in the
Nordic region. In addition, if Genmab exercised the co-promotion option,
Genmab would have had the option to co-promote Bexxar™ and Arranon™ in the
US and Atriance™ in the relevant countries of the Nordic region. In
December 2008, Genmab announced an amendment to its agreement with GSK.
Under the terms of the amendment, Genmab will receive a one-time payment of
$4.5 million from GSK upon the FDA's acceptance for review of the
filing of the first Biologcis License Application (BLA) for ofatumumab in
an oncology indication in the USA in exchange for terminating its option to
co-promote ofatumumab. The sale of the co-promotion option does not affect
the royalty or milestone revenue that Genmab may receive.
Genmab has achieved six milestone payments under the collaboration with
GSK. In June 2007, Genmab achieved the first milestone for positive results
in the Phase II RA study, triggering a payment of DKK 116 million
(approximately USD 21 million) from GSK. Genmab achieved the second
milestone under the collaboration in December 2007 when the first patient
was treated in the Phase II DLBCL study, triggering a milestone of DKK 87
million (approximately USD 18 million) to Genmab. In January 2008, Genmab
reached the third milestone payment of DKK 87 million (approximately USD 18
million). The milestone was triggered by the first patient receiving
treatment in the Phase III RA program. The fourth milestone payment of DKK
29 million (approximately USD 6 million) was triggered by treatment of the
first patient in the Phase II study for RRMS in June 2008. In August
2008, a fifth milestone payment of DKK 232.7 million (approximately USD
48.5 million) was triggered by the achievement of positive results in
the ofatumumab Phase III CLL study. In October 2008, a sixth milestone
payment of approximately DKK 29 million (approximately USD 5.6 million) was
triggered by the first patient receiving treatment in the ofatumumab Phase
I study in relapsed/refractory follicular non-Hodgkin's lymphoma and
chronic lymphocytic leukemia in Japan. To date, Genmab has received an
approximate total of DKK 581 million (approximately USD 115.6 million) in
milestone payments under the GSK collaboration.
Genmab has a unique alliance with Medarex that gives us access to the UltiMAb® system for creating
the full range of human antibody isotypes. Under this agreement, Genmab has
the right to obtain licenses for an unlimited number of antibodies and owns
the worldwide development and commercialization rights to these products.
Genmab’s principal obligation under this agreement is to make royalty
payments in connection with any such product licenses. Genmab received these
rights in exchange for stock in the company, and we also received 16 fully
paid up product licenses, which require no further payments to Medarex.
In addition, in June 2001, we entered into a collaboration with Medarex to
develop a human antibody to treat inflammation, HuMax-Inflam™ (now called
HuMax-IL8™). In an asset exchange agreement in September 2007, Genmab
gained full rights to HuMax-IL8.
In May 2001, we entered into a collaboration with Roche to develop human antibodies to disease targets identified by Roche for the entire Roche organization. Under this collaboration, we could receive milestones, license fees as well as royalty payments on commercial sales. In certain circumstances, we could obtain rights to develop products based on disease targets identified by Roche.
In 2002, we expanded our alliance with Roche, and Roche made an equity investment in Genmab totalling USD 20 million at a price of DKK 180 per share. At the time, Roche announced plans to identify 15 new antibody programs on top of the four programs that were already ongoing under the direction of the joint Roche-Genmab Research Committee. Under the current agreement, Genmab will receive milestones as well as royalty payments on successful products and in certain circumstances Genmab could obtain rights to develop products based on disease targets identified by Roche. If all goals are reached, the value of the collaboration to Genmab could be as high as USD 100 million plus royalties. In 2004, Roche selected clinical candidates for four targets, each targeting a different area. Roche has filed three Investigational New Drug applications with the US FDA and a clinical trial application with the British regulatory authorities for four Genmab antibodies developed under the collaboration, marking a total of twelve milestones achieved under the agreement and triggering milestone payments to Genmab.
The disease targets for the antibody programs developed between Roche and Genmab were announced in December 2006. These include inflammation, oncology, respiratory and vascular diseases. Three of the antibodies are in Phase I development and one is in Phase II. The development of one of the programs is carried out in collaboration with Genentech, where Roche owns a majority stake.
UltiMAb® is a trademark of Medarex, Inc.
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