Last kr223.50 DKK
Change Today -1.10 / -0.49%
Volume 89.7K
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As of 11:01 AM 09/2/14 All times are local (Market data is delayed by at least 15 minutes).

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03/5/14 - kr260.00
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genmab a/s (GEN) Details

Genmab A/S, a biotechnology company, develops human antibody therapeutics for the treatment of cancer in Denmark, the Netherlands, the United States, and internationally. Its product pipeline includes Ofatumumab, a human monoclonal antibody, which is in Phase IV clinical studies for the treatment of chronic lymphocytic leukemia; Phase III clinical studies to treat follicular lymphoma, diffuse large B-cell lymphoma, and pemphigus vulgaris; Phase II clinical studies for the treatment of relapsing-remitting multiple sclerosis, and Waldenstrom’s Macroglobulinemia, as well as Daratumumab, a human CD38 monoclonal antibody that is in Phase I/II clinical studies to treat multiple myeloma. The company’s product pipeline also comprises HuMax-TF-ADC, an antibody-drug conjugate (ADC), which is in Phase I clinical studies for the treatment of solid tumors; and Teprotumumab, a human antibody that is in Phase II clinical studies for the treatment of active thyroid eye disease. In addition, it has approximately ten active pre-clinical pipeline programs, including naked antibodies and bispecific antibodies developed using DuoBody technology and ADC. The company has collaborations with GlaxoSmithKline, Janssen Biotech, Inc. (Janssen), Seattle Genetics, Inc., Roche, and H. Lundbeck A/S; and technology partnerships with Medarex, Novartis, and Janssen. Genmab A/S was founded in 1999 and is based in Copenhagen, Denmark.

170 Employees
Last Reported Date: 08/13/14
Founded in 1999

genmab a/s (GEN) Top Compensated Officers

Co-Founder, Chief Executive Officer and Presi...
Total Annual Compensation: kr10.7M
Chief Financial Officer and Executive Vice Pr...
Total Annual Compensation: kr4.9M
Compensation as of Fiscal Year 2013.

genmab a/s (GEN) Key Developments

Genmab A/S Reports Earnings Results for the First Half Ended June 30, 2014; Revised Earnings Guidance for 2014

Genmab A/S reported earnings results for the first half ended June 30, 2014. For the first half, the company's revenue increased DKK 65 million or 22% to DKK 363 million in the first half of 2014. The increase was mainly driven by higher revenue related to daratumumab collaboration with Janssen Biotech Inc.; partly offset by lower milestones and royalties related to its collaboration with GSK. Operating income was DKK 65 million compared to an operating income of DKK 11 million in the corresponding period for 2013, an improvement of DKK 54 million, which was driven by increased revenue, partly offset by the increase in operating expenses. The company is improving its 2014 financial guidance published on May 1, 2014, due to increased revenue.

Genmab A/S and Janssen Biotech, Inc. Announce Phase III Study of Daratumumab in Front Line Multiple Myeloma

Genmab A/S announced that its collaboration partner, Janssen Biotech, Inc. plans to start a new Phase III study of daratumumab in multiple myeloma. The study (MMY3008) will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone as front line treatment for patients who are not considered candidates for stem cell transplantation. The study is planned to start in the first half of 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year. Today's news is the fourth daratumumab Phase III study to be announced.

GlaxoSmithKline plc and Genmab A/S Announce Positive Interim Result for Phase III Study of Ofatumumab as Maintenance Therapy for Relapsed CLL

GlaxoSmithKline plc and Genmab A/S announced that an Independent Data Monitoring Committee (IDMC) interim analysis of a Phase III study, PROLONG (OMB 112517), reached the predefined significance level for efficacy (p<=0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra(tm)) met the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukemia (CLL) who responded to treatment at relapse. The IDMC did not identify any new safety signals and will continue to monitor patients for safety until all study patients complete therapy. Further analysis of the safety and efficacy data is underway and will be shared with regulators and the scientific community in the coming months. This pivotal Phase III study was designed to randomize up to 532 patients with relapsed CLL who have responded to treatment at relapse, to either ofatumumab maintenance treatment or no further treatment (observation). Patients in the ofatumumab arm receive an initial dose of 300 mg of ofatumumab, followed one week later by a second dose of 1,000 mg, then doses of 1,000 mg every 8 weeks for up to two years, while patients in the observation treatment arm receive no further treatment. The primary endpoint of the study is PFS. Secondary objectives will evaluate clinical benefit, safety, tolerability, the health-related quality of life of subjects treated with ofatumumab versus no further treatment, and pharmacokinetics among relapsed CLL patients receiving maintenance therapy with ofatumumab. Ofatumumab--a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes--is not approved or licensed anywhere in the world as maintenance treatment for relapsed CLL. the USA, ofatumumab is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the EU, ofatumumab is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Ofatumumab is also approved for first-line use in Russia. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK. Ofatumumab has been associated with infusion reactions. These reactions may result in temporary interruption or withdrawal of treatment or death. Pre-medications attenuate infusion reactions but these may still occur, predominantly during the first infusion. Infusion reactions may include, but are not limited to, anaphylactic reactions, bronchospasm, cardiac events (eg myocardial ischemia /infarction, bradycardia), chills/rigors, cough, cytokine release syndrome, diarrhea, dyspnoea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary edema, pruritus, pyrexia, rash, and urticaria. Even with pre-medication, severe reactions, including cytokine release syndrome, have been reported following ofatumumab use. In cases of severe infusion reaction, the infusion of ofatumumab must be interrupted immediately and symptomatic treatment instituted. Infusion reactions occur more frequently on the first day of infusion and tend to decrease with subsequent infusions. Patients with a history of decreased pulmonary function may be at a greater risk for pulmonary complications from severe reactions and should be monitored closely during infusion of ofatumumab. The safety of, and ability to generate a primary or anamnestic response to, immunization with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied.


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