Genmab

Genmab A/S develops antibody therapeutics for the treatment of cancer and other diseases primarily in Denmark. The company markets DARZALEX, a human monoclonal antibody for the treatment of patients with multiple myeloma (MM); teprotumumab for the treatment of thyroid eye disease; ofatumurnab, a human monoclonal antibody to treat chronic lymphocytic leukemia (CLL) and multiple sclerosis; and Amivantamab for advanced or metastatic gastric or esophageal cancer and NSCLC. Its products include daratumumab to treat MM, non-MM blood cancers, and AL amyloidosis; GEN1047; tisotumab vedotin for treating cervical, ovarian, and solid cancers; DuoBody-PD-L1x4-1BB, and DuoBody-CD40x4-1BB for treating solid tumors; Epcoritamab for relapsed/refractory diffuse large B-cell lymphoma and chronic lymphocytic leukemia; and HexaBody-CD38 and DuoHexaBody-CD37 for treating hematological malignancies. The company's also develops products, which is in Phase 2 comprise Teclistamab for vaso-occlusive crises; Camidanlumab tesirine to treat hodgkin lymphoma and solid tumors; JNJ-64007957 and JNJ-64407564 to treat MM; PRV-015 for treating celiac disease; Mim8 for treating haemophilia A; and Lu AF82422 for treating multiple system atrophy disease. In addition, it has approximately 20 active pre-clinical programs. The company has a commercial license and collaboration agreement with Seagen Inc. to co-develop tisotumab vedotin. It also has a collaboration agreement with CureVac AG for the research and development of differentiated mRNA-based antibody products; AbbVie for the development of epcoritamab; and collaborations with BioNTech, Janssen, Novo Nordisk A/S, BliNK Biomedical SAS, and Bolt Biotherapeutics, Inc. Genmab A/S was founded in 1999 and is headquartered in Copenhagen, Denmark.

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. 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 DKK 1.56 billion, and had a second public offering in January 2006 yielding DKK 800 million.

The company's initial R&D location was a nine-story building in Utrecht Science Park, in the Netherlands; this was replaced with an "R&D Center" also in Utrecht, in June 2018. By mid-2019, this new facility was at capacity, and plans were set afoot to build an adjacent, connected facility.By 2001, Medarex and Genmab had come back together in a drug development partnership, which highlighted the manufacturing deficit and clinical development expertise of Genmab relative to Medarex.In 2005 the Biotechnology Industry Organization and the Long Island Life Sciences Initiative honored Genmab with a James D. Watson Helix Award.2008 saw the company purchasing a 22,000-litre, 36-acre antibody manufacturing plant in Brooklyn Park, Minnesota from PDL BioPharma, with plans to retain all 170 employees thereat. However, the company ran into financial trouble originating from several quarters, and a decision to sell the facility was reached in late 2009, after Genmab had started producing development scale batches from the facility. In 2008, the world was experiencing a financial crisis as a whole, and GlaxoSmithKline decided to exit oncology, which impacted co-development of ofatumumab, an oncology-directed product. In tandem with the sale of the plant, the company reorganized and planned to dismiss about 300 employees. Selling the facility, though, proved very difficult, due in large part to the global financial crisis; by 2012, Genmab had decided to simply write-off the entire facility from the company's balance sheets. A sale of the facility to Baxter came in February 2013.Following the failed strategy of in-housing manufacturing, Genmab chose to thereafter completely outsource both manufacturing and the conduct of clinical trials.The Company's first product, Arzerra reached the US market in 2009 for refractory chronic lymphocytic leukemia.

Lisa N. Drakeman, Ph.D. had been a vice president at Medarex and wife of Donald Drakeman, Medarex's CEO and President at the time. Drakeman was one of Genmab's co-founders and was appointed chief executive officer of the company upon incorporation in 1999, also joining the board of directors. As of 2002, Drakeman remained in the CEO role, but by 2010 she had announced her retirement.In 2010 Jan Van de Winkel, a co-founder of the firm, was appointed as President and CEO of Genmab. Since the company started in 1999, he had been Genmab's chief scientific officer ; he had concurrently served as head of research, then president of R&D. As of 2019, Van de Winkel remained CEO of the firm. Van de Winkel is a scientist, having produced more than 300 publications during his career.

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, 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 DKK 2,033 million . The potential value of this agreement could be DKK 12.0 billion if all milestones are reached and commercial success is reached in the fields of cancer, autoimmune, and inflammatory disease. The intention of GlaxoSmithKline to exit oncology, disagreement around milestones reached, and financial difficulties of Genmab, led to re-negotiation of the partnership in mid-2010, resulting in an immediate US$135 million payment by GlaxoSmithKline and future financial and licensing concessions on the part of Genmab.In addition, Genmab has collaborations with Roche , Lundbeck and Seattle Genetics.