FDA Advisory Panel Makes Favorable Recommendation For GlaxoSmithKline And Genmab's ARZERRA(TM) (ofatumumab)

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 30 May 2009 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA(TM) (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.

"The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. While current initial treatments for CLL can provide prolonged remissions, some patients will progress rapidly and relapse, which highlights the need for new therapies," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Medicines Development, GlaxoSmithKline Oncology. "We look forward to working with the FDA towards an approval for ofatumumab."

CLL is the most common form of adult leukemia in the Western world, and the treatment of patients with relapsed disease remains a significant challenge. Patients who have not responded to current standard therapies, or whose disease has returned following prior treatments, typically experience poorer clinical outcomes such as infections and death. Less than 25 percent of CLL patients who are resistant to current treatments respond to available therapies.

"The positive vote by ODAC confirms that ofatumumab may offer a new treatment option for patients who have received prior therapies with this type of CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "Today's vote is positive affirmation for this medicine, which is a result of years of dedicated research and collaboration between Genmab and GSK."

The advisory committee made its decision based on an interim analysis of a pivotal trial that was presented at the American Society of Hematology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.

About CLL

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. Based on 2007 worldwide estimates, leukemia (all types) accounted for more than 330,000 new cases and more than 245,000 deaths.

CLL cells are malignant B-cells that have a low concentration of CD20 molecules on their surface. B-cells normally protect the body from invading pathogens by developing into plasma cells, which make antibodies. These antibodies directly inactivate pathogens or attach to pathogens to prepare them for destruction by other white blood cells.

About Ofatumumab

Ofatumumab is an investigational monoclonal antibody that targets a membrane-proximal (close to the cell surface), small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule on B-cells. Ofatumumab also binds to the large loop of the CD20 molecule. The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.

Ofatumumab is being developed under a collaboration between Genmab and the GSK Oncology and BioPharm R&D Units.

Ofatumumab is not yet approved in any country.

About GlaxoSmithKline (GSK)

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.

GSK Oncology is dedicated to producing innovations in cancer 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. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy, and targeted therapies.

GSK's BioPharm R&D division has a rich early pipeline based on cutting edge molecular biology and genetic technology and a mature late-stage portfolio that will provide important medicines to oncology.

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.

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.

Forward looking statement for Genmab

This press release 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 product discovery and development, 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.

Source: GlaxoSmithKline