Genmab
Encyclopedia
Genmab A/S is a Danish
Denmark
Denmark is a Scandinavian country in Northern Europe. The countries of Denmark and Greenland, as well as the Faroe Islands, constitute the Kingdom of Denmark . It is the southernmost of the Nordic countries, southwest of Sweden and south of Norway, and bordered to the south by Germany. Denmark...

 biotechnology company, founded in February 1999 and based in Copenhagen
Copenhagen
Copenhagen is the capital and largest city of Denmark, with an urban population of 1,199,224 and a metropolitan population of 1,930,260 . With the completion of the transnational Øresund Bridge in 2000, Copenhagen has become the centre of the increasingly integrating Øresund Region...

. Internationally, it operates through the subsidiaries Genmab BV in Utrecht
Utrecht (city)
Utrecht city and municipality is the capital and most populous city of the Dutch province of Utrecht. It is located in the eastern corner of the Randstad conurbation, and is the fourth largest city of the Netherlands with a population of 312,634 on 1 Jan 2011.Utrecht's ancient city centre features...

, The Netherlands, and Genmab, Inc in Princeton, New Jersey
Princeton, New Jersey
Princeton is a community located in Mercer County, New Jersey, United States. It is best known as the location of Princeton University, which has been sited in the community since 1756...

, USA. The Company is publicly traded on the NASDAQ OMX Copenhagen A/S. Genmab expanded with an antibody manufacturing facility in Brooklyn Park, Minnesota, USA in 2008, which it now plans to close.
Genmab's Technology is licensed from Medarex
Medarex
Medarex is an American biotechnology company owned by Bristol Myers Squibb and based in Princeton, New Jersey. The company has manufacturing facilities in Bloomsbury and Annandale, New Jersey, and research facilities in Milpitas and Sunnyvale, California. Medarex specializes in therapeutic...

 to create fully human high affinity antibodies using transgenic mice. These antibodies are less likely to elicit an allergic reaction and other side effects compared with other types of manmade antibodies containing other animal proteins because the IgG antibodies produced have human proteins. This technology is called the HuMab-Mouse technology. One benefit of using this type of technology is that there is no need for humanization or complicated genetic engineering to make this antibody fit for humans which cuts down on expenses and time spent developing it. It can be generated within months and can be selected to bind to specific antigens such as tumor cells and other infectious agents.
Genmab also has developed its own technology called UniBody, which is used to make smaller antibodies in contrast to the traditional full sized monoclonal antibody. Its smaller size allows for better distribution over larger target areas like tumors. The UniBody can only bind to one site and doesn’t elicit a harmful immune response by binding to two sites and over-activating cell growth. It does not kill target cells but rather silences or inhibits them. Thus it can be used to treat certain cancers, inflammations, allergies and asthmas, where killing the cell isn’t the objective.
The technology modifies the human IgG4 antibody. Normally the IgG4 is considered inert and doesn’t elicit an immune response. However, they are also unstable and fall apart easily, which makes them unsuitable for therapeutic settings. Genmab changes the shape of the IgG4 antibody by eliminated the hinge, the part of the antibody that creates the “Y” shape. This halves the antibody, creating a smaller version now known as their UniBody. This smaller version can only bind to one site and does not stimulate cancer cells to grow.

History of the Company

Genmab was founded as a European spin-off of American Biotech company Medarex
Medarex
Medarex is an American biotechnology company owned by Bristol Myers Squibb and based in Princeton, New Jersey. The company has manufacturing facilities in Bloomsbury and Annandale, New Jersey, and research facilities in Milpitas and Sunnyvale, California. Medarex specializes in therapeutic...

 in February 1999. Danish investment firm BankInvest provided the seed investment for the company to start up in Copenhagen. Lisa Drakeman, a vice president at Medarex and wife of Donald Drakeman
Donald L. Drakeman
Donald L. Drakeman is an American entrepreneur, venture capitalist, business executive, academic, and scholar based in South Carolina. He has since 2007 been a Venture Partner in Advent Venture Partners, a venture capital firm based in London, in connection with which he is a member of the firm's...

, Medarex's CEO and President at the time, was appointed CEO of Genmab upon incorporation. Like Medarex, Genmab began work producing monoclonal antibodies for life threatening or debilitating diseases.
Rising quickly in the Biotech world, Genmab attracted many investors, especially venture capital firms. The company went public in October 2000, earning 1.56 billion Danish kroner, and had a second public offering in January 2006 yielding 800 million kroner. That same year, Genmab also had a licensing agreement with GlaxoSmithKline worth $1.6 billion for the antibody ofatumumab.
Besides GSK, Genmab also has licensing deals with Amgen, Roche and Lundbeck involving therapeutic monoclonal antibodies with multiple indications. In 2005 the Biotechnology Industry Organization
Biotechnology Industry Organization
Biotechnology Industry Organization is an industry lobby group founded 1993 in Washington, D.C. Carl B. Feldbaum was the president until he retired in 2004, and was succeeded by James C. Greenwood.-External links:* *...

 (BIO) and the Long Island Life Sciences Initiative honored Genmab with a James D. Watson
James D. Watson
James Dewey Watson is an American molecular biologist, geneticist, and zoologist, best known as one of the co-discoverers of the structure of DNA in 1953 with Francis Crick...

Helix Award. The Company's first product, Arzerra (ofatumumab) reached the US market in 2009 for refractory chronic lymphocytic leukemia.

Partnerships

Amgen: In May of 1999, Genmab entered a sub-license agreement with Amgen where it would gain rights to the IL15 antibodies. In October 2001, this was replaced by a direct license agreement where Amgen retained exclusive commercialization options for the products through phase II. Amgen has also expanded its agreement to a new antibody program targeting additional disease targets. Amgen has discontinued development of the IL15 antibody, 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 as this time, no further internal development of a lead indication is planned.

GlaxoSmithKline: In December 2006, Genmab entered a deal with GlaxoSmithKline to co-develop and commercialize ofatumumab, which is a drug that could be used for treatment in CD20 positive B-cell chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, rheumatoid arthritis and other indications. The agreement gave Genmab a license fee of DKK 582 million and GSK bought 4,471,202 shares of Genmab for 2,033 million. The potential value of this agreement could be 12.0 billion DKK if all milestones are reached and commercial success is reached in the fields of cancer, autoimmune, and inflammatory disease. Until 2008, Genmab will bear the entire development cost, after which the costs will be shared equally between the two. Genmab and GSK amended the agreement in July 2010. GSK has taken responsibility for developing ofatumumab in autoimmune indications while continuing to jointly develop ofatumumab with Genmab in oncology indications. Genmab received an up front payment of GBP 90 million from GSK in relation to the amendment and the Company's future funding commitment is capped at GBP 145 million. Further milestones due to Genmab under the oncology development program will be reduced by 50%. GSK is now solely responsible for funding development in autoimmune indications and Genmab will forgo development milestones for autoimmune indications and the first two sales milestones.

In addition, Genmab has collaborations with Roche, Lundbeck and Seattle Genetics.

Research pipeline

Status of major offerings in Genmab's research pipeline, as of September 2010.
Product Disease Indications Phase Partner
Ofatumumab (20 Studies) Chronic lymphocytic leukemia (CLL) III GSK
Ofatumumab Non-Hodgkin’s Lymphoma (NHL) III GSK
Ofatumumab Rheumatoid arthritis (RA) III GSK
Ofatumumab Diffuse Large B-cell Lymphoma (DLBCL) III GSK
Ofatumumab Relapsing Remitting Multiple Sclerosis (RRMS) II GSK
Ofatumumab Waldenstrom’s Macroglobulinemia (WM) II GSK
Zalutumumab (6 studies) Head & Neck Cancer III -
Daratumumab Multiple Myeloma I/II -
RG4930 Asthma - Target: Ox40L I Roche
RG1512 Peripheral vascular disease - Target: P-selectin I Roche
HuMax-cMet Cancer Pre-clinical -
HuMax-TF Cancer Pre-clinical Seattle Genetics
HuMax-Her2 Cancer Pre-clinical -
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