Summary: GSK and Genmab have received approval of Arzerra (ofatumumab) from the
FDA for CLL that is refractory to fludarabine and alemtuzumab.
Philadelphia, PA and Copenhagen, Denmark; October 26, 2009 - Today,
GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated
approval of ArzerraTM (ofatumumab) from the US Food and Drug Administration for
use in patients with chronic lymphocytic leukemia (CLL) that is refractory to
fludarabine and alemtuzumab.
“The approval of Arzerra brings an important new treatment option to patients
with refractory CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. “This approval also marks a key milestone for Genmab as it is our first
antibody to reach the market. All of us involved in the development of Arzerra
are pleased that we have been able to move the product so quickly through
research and development and meet our goal of providing this innovative therapy
to patients.”
The approval is based on results from a pivotal study in which 42% of patients
with CLL who were refractory to both fludarabine and alemtuzumab (two therapies
used in treating CLL) responded to treatment with Arzerra. These patients had a
median duration of response of 6.5 months. The most common adverse reactions
(≥10%) seen were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia,
fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract
infections. The most common serious adverse reactions seen were infections
(including pneumonia and sepsis), neutropenia, and pyrexia.
“Arzerra is a significant step forward in helping patients and physicians better
manage the challenges of refractory CLL. Patients now have a new choice,” said
Kathy Rouan, Ph.D., Vice President and Medicines Development Leader at
GlaxoSmithKline. “The Arzerra approval demonstrates the commitment of the GSK
BioPharm and Oncology Units to developing new biopharmaceutical treatment
options for cancer patients.”
Arzerra is a monoclonal antibody that causes the body's immune response to fight
against normal and cancerous B-cells. Arzerra attaches to the small and large
loop epitopes - on a molecule called CD20, which is found on the surface of
B-cells, the type of cell which becomes cancerous in CLL.
The approval of Arzerra was supported by a positive recommendation by the FDA's
Oncologic Drugs Advisory Committee (ODAC) at ASCO on May 29, 2009, in which the
panel voted, 10-3, that the Arzerra data were likely to predict clinical benefit
for patients with CLL whose disease is refractory to fludarabine and
alemtuzumab.
Arzerra is anticipated to be available for prescription use in the coming weeks.
GSK has added Arzerra to its expanding patient assistance program, Commitment to
Access, and has expanded the program. This program assists eligible patients,
with or without insurance, with paying for cancer medicines. For more
information about the program, visit www.CommitmentToAccess.com or call
1-8ONCOLOGY1 (1-866-265-6491).
Conference Call
Genmab will hold a conference call to discuss today's news on October 27, 2009,
at
2:30 pm CEST
1:30 pm BST
9:30 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1-877-941-8609 (in the US) and provide conference ID number 4171231
+1-480-629-9818 (outside the US) and provide conference ID number 4171231
To listen to a live webcast of the call please visit www.genmab.com.
The GSK Biopharm R&D Unit seeks to harness the therapeutic potential of
biopharmaceuticals for the benefit of patients with debilitating and life
threatening disease. We work in tandem with the Oncology R&D Unit, which is
dedicated to producing innovations in cancer treatment that will make profound
differences in the lives of patients. Through GSK's revolutionary ‘bench to
bedside' approach, we are transforming the way treatments are discovered and
developed, resulting in one of the most robust pipelines in the oncology sector.
GlaxoSmithKline - 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 www.gsk.com
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using
cutting-edge technology to create and develop products to address unmet medical
needs. Our primary goal is to improve the lives of patients who are in urgent
need of new treatment options. For more information on Genmab's products and
technology, visit www.genmab.com.
GSK Enquiries
UK Media enquiries: Philip Thomson +44 20 8047 5502
Claire Brough +44 20 8047 5502
Stephen Rea +44 20 8047 5502
Alexandra Harrison +44 20 8047 5502
Gwenan White +44 20 8047 5502
US Media enquiries: Nancy Pekarek +1 919 483 2839
Kevin Colgan +1 919 483 2839
Mary A. Rhyne +1 919 483 2839
Sarah Alspach +1 919 483 2839
Ken Inchausti +1 919 483 2839
European Analyst/Investor enquiries: David Mawdsley +44 20 8047 5564
Sally Ferguson +44 20 8047 5543
Gary Davies +44 20 8047 5503
US Analyst/Investor enquiries: Tom Curry +1 215 751 5419
Jen Hill Baxter +1 215 751 7002
Genmab Enquiries
Helle Husted, Vice President, Investor Relations T: +45 33 44 77 30
M: +45 25 27 47 13
E: h.husted@genmab.com
Cautionary statement regarding forward-looking statements for GSK:
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, 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. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s Annual
Report on Form 20-F for 2007.
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This Stock Exchange Release contains forward looking statements. The words
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identify forward looking statements. Actual results or performance may differ
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“Risk Management” in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM);
HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(TM) is a trademark of GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com
Stock Exchange Release no. 39/2009
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