Genmab Collaborator GSK Starts New Ofatumumab Phase III Study in Rare Skin Disorder

Genmab Collaborator GSK Starts New Ofatumumab Phase III Study in Rare Skin

Company Announcement

  *First Phase III study with subcutaneous formulation of ofatumumab
  *Ofatumumab to be investigated in new autoimmune area - pemphigus vulgaris
  *Patient recruitment in Phase III study to start soon

COPENHAGEN, Denmark, July 4, 2013 (GLOBE NEWSWIRE) --Genmab A/S
(Copenhagen:GEN) announced today that GSK will start a new Phase III study of
ofatumumab given subcutaneously to treat pemphigus vulgaris, a rare autoimmune
disorder of the skin.

"We are pleased that GSK are investigating ofatumumab in the treatment of
pemphigus vulgaris, a seriously debilitating and sometimes life-threatening
autoimmune disease," said Jan van de Winkel, Ph.D., Chief Executive Officer of

About the study

The study is double blinded and will include approximately 136 patients with
active pemphigus vulgaris who have achieved disease control on a stable dose
of steroids prior to randomization. Patients in this study will be randomized
equally into one of two arms. Patients will receive either ofatumumab (60 mg)
or placebo every 12 weeks for a total of five doses over which time a
scheduled gradual steroid reduction will be undertaken. Patients will then be
followed for at least 12 weeks longer. The study objectives are to establish
the efficacy and safety of subcutaneous ofatumumab in pemphigus vulgaris,
based on disease remission. This study is being conducted by GlaxoSmithKline

About pemphigus vulgaris

Pemphigus vulgaris is a rare, chronic skin disorder in which the immune system
malfunctions and produces antibodies that attack healthy cells in the skin and
mucous membranes. This causes burn-like blisters and sores to appear on the
skin or mucous membranes and may lead to secondary skin infections,
dehydration, spread of infection through the bloodstream (sepsis) and death.
The incidence of pemphigus vulgaris is approximately seven people per million
worldwide. The current standard treatment for pemphigus vulgaris is systemic

About ofatumumab

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20
molecule encompassing parts of the small and large extracellular loops
(Teeling et al 2006). Ofatumumab is being developed under a co-development and
commercialization agreement between Genmab and GSK. Under the companies'
agreement, GSK is responsible for development of ofatumumab in autoimmune
indications and related costs.

In the pivotal trial on which approval for chronic lymphocytic leukemia
refractory to fludarabine and alemtuzumab was based (total population n=154),
the most common adverse reactions (>=10%, all grades) to ofatumumab were
neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnoea,
rash, nausea, bronchitis, and upper respiratory tract infections. The most
common serious adverse reactions were infections (including pneumonia and
sepsis), neutropenia, and pyrexia. A total of 108 patients (70%) experienced
bacterial, viral, or fungal infections. A total of 45 patients (29%)
experienced >=Grade 3 infections, of which 19 (12%) were fatal. The proportion
of fatal infections in the fludarabine- and alemtuzumab-refractory group was

Ofatumumab is not approved or licensed anywhere in the world to treat
pemphigus vulgaris.

About Genmab A/S

Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company's first marketed
antibody, ofatumumab (Arzerra^®), was approved to treat chronic lymphocytic
leukemia in patients who are refractory to fludarabine and alemtuzumab after
less than eight years in development. Genmab's validated and next generation
antibody technologies are expected to provide a steady stream of future
product candidates. Partnering of innovative product candidates and
technologies is a key focus of Genmab's strategy and the company has alliances
with top tier pharmaceutical and biotechnology companies. For more
information visit


Rachel Curtis Gravesen, Senior Vice President, Investor Relations &

T: +45 33 44 77 20; M: +45 25 12 62 60; E:

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Company Announcement no. 30

CVR no. 2102 3884

Genmab A/S

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