FDA EXTENDS REVIEW OF ARZERRA™ (OFATUMUMAB)
Summary: GlaxoSmithKline and Genmab announced that the FDA extends review
ARZERRA by three months.
London, UK and Copenhagen, Denmark; June 16, 2009 - GlaxoSmithKline (NYSE: GSK)
and Genmab A/S (OMX: GEN) today announced that the United States Food and Drug
Administration (FDA) informed the companies that the agency has extended the
action date for the ofatumumab BLA application by three months.
The BLA was submitted on January 30, 2009 and was granted priority review by the
FDA. Under priority review, the FDA sets the target date for a decision at six
months, rather than the standard 10 month review. The three month extension will
allow the agency to review additional chemistry and manufacturing data submitted
on June 5. The new action date for the BLA is October 31, 2009.
An FDA Oncology Drugs Advisory Committee (ODAC), held on May 29, 2009, voted
10-3 that ofatumumab was likely to offer clinical benefit for certain patients
with chronic lymphocytic leukemia (CLL). Data from the pivotal trial of
ofatumumab were presented at the American Society of Hematology 2008 annual
meeting and at American Society of Clinical Oncology 2009 annual meeting.
CLL is the most common adult leukemia and one of the most common malignant
lymphoid diseases. In the United States, about 90,000 people are living with
CLL, with approximately 15,000 estimated new cases being diagnosed in 2009.
GSK and Genmab are committed to working with the FDA in order to bring this
potential new treatment option to patients.
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 company
information, visit GlaxoSmithKline at 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.
GlaxoSmithKline Enquiries:
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| UK Media enquiries | Philip Thomson | (020) 8047 5502 |
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| | David Outhwaite | (020) 8047 5502 |
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| | Stephen Rea | (020) 8047 5502 |
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| US Media enquiries | Lisa Behrens | (919) 699 1758 |
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| | Ken Inchausti | (919) 699 1758 |
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| European Analyst/ Investor enquiries | David Mawdsley | (020) 8047 5564 |
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| | Sally Ferguson | (020) 8047 5543 |
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| | Gary Davies | (020) 8047 5503 |
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| US Analyst/ Investor enquiries | Tom Curry | (215) 751 5419 |
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| | Jen Hill Baxter | (215) 751 7002 |
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| Genmab Enquiries | | |
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| Vice President, Investor Relations | Helle Husted | T +45 33 44 77 |
| | | 30 |
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| | | M +45 25 27 47 |
| | | 13 |
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| | | hth@genmab.com |
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Cautionary statement regarding forward-looking statements for GSK:
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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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Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; HuMax-EGFr™;
HuMax-IL8™; HuMax-TAC™; HuMax-HepC™; HuMax-CD38™; HuMax-CD32b™; HuMax-TF™;
HuMax-Her2™; HuMax-VEGF™ and UniBody® are all trademarks of Genmab A/S. Arzerra™
is a trademark of GlaxoSmithKline.
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