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GSK and Genmab receive accelerated approval for Arzerra™

Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.

Issued: Monday, October 26, 2009, Philadelphia, PA

Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of Arzerra TM (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 (ofatumumab).   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 (ofatumumab) 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 (ofatumumab) 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 data for ARZERRA were likely to predict clinical benefit for patients with CLL whose disease is refractory to fludarabine and alemtuzumab.

ARZERRA (ofatumumab) is anticipated to be available for prescription use in the coming weeks.

GSK has added Arzerra (ofatumumab) to its 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).

The GSK Biopharm R&D Unit seeks to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with debilitating and life threatening diseases. 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

Genmab A/S 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

 

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Cautionary statement regarding forward-looking statements
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 2008.