What is Genmab?

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 and we are continuing to build a broad portfolio of new therapeutic products.

What is the history of Genmab?

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 NASDAQ OMX 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 at the time. 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 zanolimumab (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 ofatumumab and GSK made an equity investment in Genmab of DKK 2,033 million (approximately USD 357 million).

Genmab's first product, Arzerra® (ofatumumab), was granted accelerated approval by the FDA in October 2009, for the treatment of patients in the U.S. with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. Arzerra was launched by GSK in mid-November 2009. In April 2010, a conditional marketing authorization for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab was granted by the EU Commission.

What is Genmab's business strategy? Why does Genmab believe it can succeed?

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 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, regulatory and manufacturing 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 offices within the United States.

What are antibodies and what is their role in fighting disease?

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 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.

How does Genmab create human monoclonal antibodies?

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.

Are antibodies an accepted form of medical treatment?

Over two dozen monoclonal antibody products from other companies are approved for use in the United States and Europe. The majority of these products entered the market in the last several years.  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.

What is the market for antibody therapeutics?

The market for therapeutic monoclonal antibodies is one of the most dynamic and commercially attractive sectors within the healthcare industry. Monoclonal antibodies are forecast to comproise the largest portion of sales growth at the fastest rate across the entire pharmaceutical industry.  Global sales of monoclonal antibodie sreached $32.2 billion in 2008 and are forecast to increase to $58 billion in 2014. (Datamonitor: "Monoclonal Antibodies: Update 2009").

What is Genmab's relationship to Medarex, Inc.?

Genmab has a unique alliance with Medarex, Inc., a wholly owned subsidiary of Bristol-Myers Squibb, 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.