GSK and Genmab Receive CHMP Positive Opinion for Arzerra(tm) in Combination with Chlorambucil or Bendamustine as a First-line

GSK and Genmab Receive CHMP Positive Opinion for Arzerra(tm) in Combination
with Chlorambucil or Bendamustine as a First-line Treatment for Patients with
Chronic Lymphocytic Leukemia (CLL) Who Are Not Eligible for Fludarabine-based

Company Announcement

  *CHMP recommends marketing authorization for Arzerra in combination with
    chlorambucil or bendamustine for patients with CLL who have not received
    prior therapy and are not eligible for fludarabine-based therapy
  *Final decision from European Commission expected in the coming months

COPENHAGEN, Denmark, May 23, 2014 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc
(LSE:GSK) and Genmab A/S (Copenhagen:GEN) announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued a positive opinion recommending a variation to the terms of
the marketing authorization for Arzerra(tm) for a new indication in
combination with chlorambucil or bendamustine for the treatment of patients
with chronic lymphocytic leukemia (CLL) who have not received prior therapy
and who are not eligible for fludarabine-based therapy.^1

"This CHMP opinion for Arzerra in the first-line setting brings GSK one step
closer to offering a new treatment option for patients with previously
untreated CLL in Europe," said Dr Rafael Amado, Head of Oncology R&D at GSK.

"We are pleased to receive the positive opinion from the CHMP for Arzerra in
combination with chlorambucil or bendamustine for first line CLL and look
forward to a final decision from the European Commission in the next few
months," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The CHMP recommendation of the first-line indication is based on results from
two trials in patients with previously untreated CLL considered inappropriate
for a fludarabine-based treatment:

  *Phase III OMB110911 study (COMPLEMENT 1), a randomised, open-label,
    parallel-arm, multicentre, pivotal Phase III study evaluating the
    combination of ofatumumab and chlorambucil (N=221) versus chlorambucil
    alone (N=226)^2
  *Phase II OMB115991, a single-arm, multicentre study that evaluated the
    efficacy of ofatumumab in combination with bendamustine (N= 44)^3

A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission (EC),^4 but does not
always result in marketing authorization. A final decision by the EC is
anticipated during the third quarter of 2014.

About Arzerra (ofatumumab)

Arzerra (ofatumumab) is a monoclonal antibody that is designed to target the
CD20 molecule found on the surface of CLL cells and normal B lymphocytes.^1

In the US, Arzerra^(r) is approved (April 2014) for use in combination with
chlorambucil for the treatment of previously untreated patients with CLL for
whom fludarabine-based therapy is considered inappropriate. For full US
prescribing information, including Boxed Warning, please see Arzerra is also
approved for first-line use in Russia.

In more than 50 countries worldwide, Arzerra is indicated as monotherapy for
the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Arzerra is being developed under a co-development and collaboration agreement
between Genmab and GSK.

Arzerra is a registered trademark of the GSK group of companies.

Safety information for Arzerra (ofatumumab)

Please consult the full Summary of Product Characteristics for all the
labelled safety information for Arzerra.


Hypersensitivity to ofatumumab or to any of the excipients.^1

Special warnings and precautions for use of ofatumumab include:

Infusion reactions^1

Ofatumumab has been associated with infusion reactions leading to temporary
interruption of treatment or withdrawal of treatment. Infusion reactions may
include anaphylactoid events, cardiac events, chills/rigors, cough, cytokine
release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension,
hypotension, nausea, pain, pyrexia, rash, and urticaria. 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.

Tumour lysis syndrome^1

In patients with CLL, tumour lysis syndrome (TLS) may occur with use of
ofatumumab. Risk factors for TLS include a high tumour burden, high
concentrations of circulating cells (>= 25,000/mm^3), hypovolaemia, renal
insufficiency, elevated pre-treatment uric acid levels and elevated lactate
dehydrogenase levels. Management of TLS includes correction of electrolyte
abnormalities, monitoring of renal function, maintenance of fluid balance and
supportive care.

Progressive multifocal leukoencephalopathy^1

Progressive multifocal leukoencephalopathy (PML) and death has been reported
in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab. If
a diagnosis of PML is suspected Arzerra should be discontinued and referral to
a neurologist should be considered.


The safety of, and ability to generate a primary or anamnestic response to,
immunisation with live attenuated or inactivated vaccines during treatment
with ofatumumab has not been studied.

Hepatitis B^1

HepatitisB virus (HBV) infection and reactivation, in some cases resulting in
fulminant hepatitis, hepatic failure and death, has occurred in patients
treated with drugs classified as CD20-directed cytolytic antibodies, including
Arzerra. All patients should be screened for HBV infection before initiation
of Arzerra treatment, patients previously exposed to HBV should be followed
closely in consultation with an expert in this disease. Patients with
evidence of prior HBV infection should be monitored for clinical and
laboratory signs of hepatitis or HBV reactivation.


Patients with a history of cardiac disease should be monitored closely.
Arzerra should be discontinued in patients who experience serious or
life-threatening cardiac arrhythmias.

The effect of multiple doses of Arzerra on the QTc interval was evaluated in a
pooled analysis of three open-label studies in patients with CLL (N = 85).
Increases above 5 msec were observed in the median/mean QT/QTc intervals in
the pooled analysis. No large changes in the mean QTc interval (i.e., >20
milliseconds) were detected.

Bowel obstruction^1

Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal
antibody therapy, including ofatumumab. Patients who present with abdominal
pain, especially early in the course of ofatumumab therapy, should be
evaluated and appropriate treatment instituted.

Laboratory monitoring^1

Cytopenias, including prolonged and late-onset neutropenia, have been reported
during ofatumumab therapy. Complete blood counts, including neutrophil and
platelet counts should be obtained at regular intervals during ofatumumab
therapy and more frequently in patients who develop cytopenias.

Sodium content^1

This medicinal product contains 34.8mg sodium per 300mg dose, 116mg sodium
per 1,000mg dose and 232mg sodium per 2,000mg dose.This should be taken
into consideration by patients on a controlled sodium diet.

The most common undesirable effects for ofatumumab include adverse events
associated with infusion reactions, cytopenias (neutropenia, anemia, febrile
neutropenia, thrombocytopenia, leucopenia) and infections (lower respiratory
tract infection, including pneumonia, upper respiratory tract infection,
sepsis, including neutropenic sepsis and septic shock, herpes virus infection,
urinary tract infection). ^ 1

GSK- one of the world's leading research-based pharmaceutical and healthcare
companies - is committed to improving the quality of human life by enabling
people to do more, feel better and live longer. For further information
please visit

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 currently has one
marketed antibody, Arzerra^(r) (ofatumumab) for the treatment of certain
chronic lymphocytic leukemia indications, a clinical pipeline with both late
and early stage programs, and an innovative preclinical pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody platform for generation of bispecific antibodies,
and the HexaBody platform which creates effector function enhanced
antibodies. Genmab's deep antibody expertise is expected to provide a stream
of future product candidates. Partnering of selected 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


UK Media enquiries:David Mawdsley+44 (0) 20 8047

Steel+44 (0) 20 8047 5502(London)

Daley+44 (0) 20 8047 5502(London)

Catherine Hartley+44
(0) 20 8047 5502(London)

US Media enquiries:Bernadette King+1 215 778
3027 (Philadelphia)

Anna Padula+1
215 751 4271 (Philadelphia)

 Melinda Stubbee+1
919 483 2510 (North Carolina)

Karen Collins+1
919 483 2527 (North Carolina)

Stephen Rea +1
215 751 4394 (Philadelphia)

Analyst/Investor enquiries: Ziba Shamsi +44 (0) 20
8047 5543 (London)

 Kirsty Collins (SRI & CG) +44 (0)
20 8047 5534 (London)

 Tom Curry+
1 215 751 5419 (Philadelphia)

Davies+44 (0) 20 8047 5503 (London)

 James Dodwell+44
(0) 20 8047 2406 (London)

 Jeff McLaughlin+1
215 751 7002 (Philadelphia)

Singah+44 (0) 20 8047 2248 (London)

Genmab enquiries: Rachel Curtis GravesenT: +45 33 44 77 20

M: +45 25 12 62 60E:

Forward Looking Statement for Genmab

This Company Announcement contains forward looking statements. The words
"believe", "expect", "anticipate", "intend" and "plan" and similar expressions
identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties related to
the outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance
of our products, our inability to manage growth, the competitive environment
in relation to our business area and markets, our inability to attract and
retain suitably qualified personnel, the unenforceability or lack of
protection of our patents and proprietary rights, our relationships with
affiliated entities, changes and developments in technology which may render
our products obsolete, and other factors. For a further discussion of these
risks, please refer to the risk management sections in Genmab's most recent
financial reports, which are available on Genmab does not
undertake any obligation to update or revise forward looking statements in
this Company Announcement nor to confirm such statements in relation to actual
results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
Y-shaped Genmab logo^(r); the DuoBody(tm) logo; the Hexabody logo(tm);
HuMax^(r); HuMax-CD20^(r); DuoBody^(r), HexaBody^TM and UniBody^(r).

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.

Registered in England & Wales:
No. 3888792

Registered Office:
980 Great West Road
Brentford, Middlesex


^1 GlaxoSmithKline. DRAFT ARZERRA Summary of Product Characteristics 2014.

^2 GlaxoSmithKline Clinical Study Register. Study OMB110911.
Accessed 19 May 2014.

^3 GlaxoSmithKline Clinical Study Register. Study 115991
Accessed 19 May 2014.

^4 European Commission. The Centralised Procedure.
Accessed 14 May 2014.
Press spacebar to pause and continue. Press esc to stop.