Genmab
 | |
| Publicly traded Aktieselskab | |
| Traded as | Nasdaq Copenhagen: GEN |
| Industry | Biotechnology |
| Founded | 1999 |
| Headquarters | Copenhagen, Denmark |
Key people | Jan Van de Winkel (President and CEO), Mats Pettersson (Chairman) |
| Products | Arzerra |
| Revenue | DKK 664 million (2013)[1] |
| DKK 69.3 million (2013)[1] | |
| Profit | DKK 112.4 million (2013)[1] |
Number of employees | 157 (2013)[1] |
| Website | www.genmab.com |
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.[2] Genmab is based in Copenhagen. Internationally, it operates through the subsidiaries Genmab BV in Utrecht, The Netherlands, and Genmab, Inc in Princeton, New Jersey, USA. The Company is publicly traded on the NASDAQ OMX Copenhagen A/S.[3]
The company has two approved antibodies, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX™ (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin’s lymphoma. They also have a broad clinical and pre-clinical product pipeline.[4]
Technology
Genmab's technology is licensed from Medarex 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 man-made 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.[5]
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 use. Genmab changes the shape of the IgG4 antibody by eliminating 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.[6]
History of the Company
Genmab was founded as a European spin-off of American Biotech company Medarex in February 1999. Danish investment firm BankInvest, under Florian Schönharting, provided the seed investment for the company to start up in Copenhagen. Lisa Drakeman, a vice president at Medarex and wife of Donald Drakeman, 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 (BIO) and the Long Island Life Sciences Initiative[7] honored Genmab with a James D. Watson Helix Award.[8] The Company's first product, Arzerra (ofatumumab) reached the US market in 2009 for refractory chronic lymphocytic leukemia.[9]
In 2010 Jan Van de Winkel was appointed as President and Chief Executive Officer of Genmab. Previously he was President, Research & Development and Chief Scientific Officer and he has over 20 years of experience in the therapeutic antibody field and served as Vice President and Scientific Director of Medarex Europe prior to Genmab. He is the author of over 300 scientific publications and has been responsible for over 40 patents and pending patent applications.[10]
Partnerships
Amgen: In May 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 (RG1507, a monoclonal antibody directed against IGF-1R, collaboration was terminated in 2009[11]), Lundbeck and Seattle Genetics.
Clinical pipeline
Status of Genmab's clinical pipeline, as of November 2015.
| Product | Disease Indications | Phase | Partner |
|---|---|---|---|
| Daratumumab | Multiple Myeloma | Approved | J&J |
| Ofatumumab (20 Studies) | Chronic lymphocytic leukemia (CLL) | Approved | GSK |
| Ofatumumab | Follicular lymphoma (FL) | III | GSK |
| Ofatumumab | Diffuse large B-cell lymphoma (DBLCL) | III | GSK |
| Ofatumumab | Pemphigus vulgaris (PV) | III | GSK |
| Ofatumumab | Relapsing Remitting Multiple Sclerosis (RRMS) | II | GSK |
| Ofatumumab | Waldenstrom’s Macroglobulinemia (WM) | II | GSK |
| HuMax-TF-ADC | Cancer | I | Seattle Genetics |
| Teprotumumab | Active thyroid eye disease | II | River Vision |
| Teprotumumab | Diabetic macular edema | I | River Vision |
References
- 1 2 3 4 "Annual Report 2013". Genmab. Retrieved 2014-05-20.
- ↑ http://www.sec.gov/Archives/edgar/data/874255/0000950130-99-001225.txt
- ↑ "Microsite GEN, Genmab, (DK0010272202)". Nasdaq Omx Nordic. Retrieved 2014-01-02.
- ↑ "About us". www.genmab.com. Retrieved 2016-07-14.
- ↑
- ↑
- ↑ "www.lilsi.org". www.lilsi.org. Retrieved 2014-01-02.
- ↑ http://www.bio.org/news/pressreleases/newsitem.asp?id=2005_0224_01
- ↑
- ↑ "Genmab - Jan van de Winkel". www.genmab.com. Retrieved 2016-07-14.
- ↑ John Carroll (2009-12-07). "Genmab shares slide after Roche dumps collaboration". FierceBiotech. Retrieved 2016-05-02.
