Genmab A/S is a publicly-traded international biotechnology company that creates and develops fully human monoclonal antibody-based products for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious diseases, rheumatoid arthritis and other inflammatory conditions and we are continuing to build a broad portfolio of new therapeutic products.

Genmab was founded as an independent company in Copenhagen in February 1999.

Within its first year and a half of existence, Genmab raised approximately USD 60 million, including a USD 40.5 million private placement, at the time the largest offering ever by a private European biotechnology company. This offering was led by Geneva-based Index Ventures and included new investors Apax Europe IV and Lombard Odier Immunology Fund, as well as BankInvest, Medarex, Inc., Lønmodtagernes Dyrtidsfond and A/S Dansk Erhvervsinvestering.

In October 2000, Genmab announced listings on the Copenhagen Stock Exchange (now the OMX Nordic Exchange Copenhagen A/S) and the Frankfurt Stock Exchange, with a Global Offering that raised DKK 1.56 billion (approximately USD 183 million) the largest European biotech IPO to date. Genmab remains one of the best-funded European biotechnology companies.

In June of 2002, Genmab received a USD 20 million (approximately DKK 170 million) equity investment from Roche in connection with a major expansion of the companies’ collaboration. In 2004, Genmab completed a successful international private placement generating DKK 478 million (approximately USD 87 million).  In 2005, Merck Serono made a USD 50 million equity investment in Genmab as part of the companies' development and commercialization agreement for HuMax-CD4®. 

Genmab completed an international private placement generating approximately DKK 845 million (approximately USD 138 million) in January 2006. Furthermore, in 2007 Genmab received a license fee of DKK 582 million (approximately USD 102 million) from GlaxoSmithKline under the December 2006 co-development and commercialization agreement for HuMax-CD20® and GSK made an equity investment in Genmab of DKK 2,033 million (approximately USD 357 million).

In February 2008, Genmab announced plans to acquire an antibody manufacturing facility from PDL BioPharma.  Genmab paid USD 240 million in cash for the facility in addition to land, equipment and access to a leased space housing a development lab.  The transaction received antitrust clearance under the Hart-Scott-Rodino Act and was finalized in March 2008.

Genmab’s focus is product development, thus our primary business plan is to create a portfolio of high quality therapeutic products and to maximize the value of our business by following a strategy of both in-house development and out-licensing of products. In this way Genmab retains a beneficial level of ownership of the commercial rights or profit-sharing opportunities for different products. We manage the risk inherent in drug development by building a broad portfolio of products with numerous antibodies in development in order to provide us with multiple opportunities to succeed.

Genmab has access to targets for new therapeutic products through numerous partnerships and in-licensing agreements including collaborations with companies such as Roche, Amgen and GlaxoSmithKline. Our strategy is to maximize the value of our antibody development capabilities by developing antibodies for novel disease targets and clinically validated targets in order to improve current product candidates.

We have assembled experienced scientific, clinical and regulatory teams with broad international experience to rapidly develop and test new therapeutic antibody products. Genmab has proven expertise to bring products through the regulatory process and into the clinic.

With offices and laboratories located in the heart of Europe, Genmab is easily accessible to partners and clinical sites. In addition, Genmab maintains administrative and clinical divisions within the United States to oversee North American clinical sites.

Antibodies are one of the body’s natural defenses against disease. When a foreign pathogen (virus, bacteria or other disease-causing agent) enters the body and is recognized, white blood cells are activated. These cells produce proteins known as antibodies that bind to the pathogen and potentially neutralize it or cause it to be destroyed.

Each antibody binds to a particular target and is specific to that target, like a key fitting into a lock. This specificity makes antibodies far less likely to cause toxic side effects than traditional drugs, like cancer chemotherapy, for example, which attacks both diseased and healthy parts of the body.

Antibodies are useful in the treatment of many types of disease. However, our immune systems do not normally make antibodies to our own cells, like cancer cells. Consequently, there are diseases, like cancer, that require the creation of special antibodies to guide the immune system. In the case of autoimmune disease, where the body is attacking itself, we may need to create antibodies to slow down or interfere with an overactive immune system.

Genmab uses groundbreaking technology that can create human antibodies which our own immune system does not make, antibodies that are specific for a disease target. We can then reproduce those antibodies in large quantities as needed. These special antibodies are called monoclonals. A monoclonal antibody is a type of antibody produced in the laboratory from a single cell known as a hybridoma.

Early monoclonal antibody technology has been based on the use of laboratory mice to create antibodies. These mouse antibodies are then engineered to reduce the amount of mouse proteins through a process that requires substantial time, money and effort. Ultimately, the resulting “chimeric” or “humanized” antibodies still contain some mouse proteins and can potentially be rejected by a patient’s immune system. Nevertheless, these part-mouse and part-human monoclonal antibodies have shown some success.

Genmab has the ability to produce antibodies that are 100 percent human. In the high tech mice used by Genmab, the mouse genes for making antibodies have been inactivated and replaced by human antibody genes. By employing these transgenic mice, Genmab can make fully human antibodies to virtually any disease target. Moreover, it is no longer necessary to genetically engineer these mice; in essence, an unlimited supply of them can be bred simply and easily. Once an antibody is created in Genmab’s mice, it can be transferred to a manufacturing facility where it can be reproduced in large quantities without any further use of mice or other animals.

Currently, 20 monoclonal antibody products from other companies are approved for use in the United States. The majority of these products entered the market in the last several years. A number of these products are also in use throughout Europe. These antibody products are being used to treat a number of diseases including breast cancer, leukemias, Crohn’s disease, acute cardiac conditions and organ transplant rejection.

The market for therapeutic monoclonal antibodies is one of the most dynamic and commercially attractive sectors within the healthcare industry.  Between 2002 and 2005, monoclonal antibodies saw explosive annual sales growth of 40 to 50 percent.  Sales passed USD 14 billion in 2005 and USD 19 billion in 2006.

Genmab has 10 products in clinical development, including three in pivotal studies and over a dozen pre-clinical programs. For detailed information on Genmab's product pipeline visit our Products in Development page.

To maximize the value of our integrated human antibody development capabilities, Genmab is forming numerous partnerships with other biotechnology and pharmaceutical companies to co-develop antibody products to novel disease targets. Our partners range from small privately held companies to major pharmaceutical and biotech companies such as Roche, Amgen and GlaxoSmithKline. A broad alliance provides Genmab with access to Medarex, Inc.’s array of proprietary technologies including the UltiMAb® platform for the rapid creation and development of human antibodies to virtually any disease target.

Genmab has a unique alliance with Medarex, Inc. that gives Genmab access to Medarex’s proprietary human antibody technologies. Genmab exchanged stock for technology access at the time of the company’s founding. Genmab received the rights to develop 16 products with no further payments to Medarex. After these 16 licenses are used, Genmab can access fee based licenses for which it would owe royalties and milestones. Under the alliance, Genmab can develop an unlimited number of products for an unlimited period of time using the transgenic technology.

The FDA’s SPA process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The FDA agreed to specific performance goals for special protocol assessment and agreement that apply to pivotal efficacy trials. To use this process, companies planning clinical trials designed to support efficacy claims submit a study protocol, as well as related questions. The FDA may then review and agree to the protocol design, execution and analyses and issue a special protocol letter to that effect. Once the FDA agrees in writing to a protocol reviewed under this process, the assessment should be considered binding on the review division of the FDA as long as the protocol is followed, unless substantial scientific issues essential to determining the safety or efficacy of the drug are identified after the testing has begun.

The National Cancer Institute-sponsored Working Group (NCI-WG) on chronic lymphocytic leukemia (CLL) has published guidelines for the design and conduct of clinical trials in CLL with the objective to facilitate comparisons of results of these trials by providing standardized eligibility, response and toxicity criteria. According to the guidelines, a complete remission (CR) is obtained when there is an absence of lymphadenopathy by physical examination and appropriate radiographic technique, spleen and liver are normal in size, absence of constitutional symptoms, and normal peripheral blood counts. A bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results have demonstrated that all above mentioned criteria has been fulfilled. The examination must show: normocellular for age, lymphocytes <30% and no nodules. A nodular partial remission has the same definition as for CR but with persistent nodules in the bone marrow. A partial remission requires a more than 50% decrease in peripheral blood lymphocyte count, a more than 50% reduction in lymphadenopathy, a more than 50% reduction in size of liver and spleen if abnormal at baseline and a more than 50% improvement in peripheral blood cell counts if not normal. Response must be maintained for a period of at least 2 months.