MabCampath® Receives Positive Opinion from European Committee for Medicinal Products for Human Use
Berlin.– Bayer Schering Pharma AG, Germany and Genzyme Corporation, Emeryville, USA, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending to grant MabCampath® (alemtuzumab) marketing authorization for treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate. Pending a favorable review by the European Commission, the product would receive marketing authorization for all EU member states as a treatment for this indication later this year. MabCampath is currently approved for the treatment of B-CLL in patients who have been previously treated with alkylating agents and have failed fludarabine therapy.
“The Committee’s recommendation underscores the potential of MabCampath to become a standard of care for patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate,” said Gunnar Riemann, Ph.D., member of the Board of Management of Bayer Schering Pharma AG. “We commend the Committee’s thorough review of the MabCampath clinical data and believe that therapy with MabCampath earlier in the course of treatment represents a significant advance for B-CLL patients.”
The CHMP positive opinion was based on data from an international open-label Phase 3 clinical trial comparing MabCampath with chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia (B-CLL). These data were presented at the 48th Annual Meeting of the American Society of Hematology (ASH) last year. The study met its primary endpoint by demonstrating superior progression free survival (PFS) in patients treated with MabCampath versus chlorambucil, with MabCampath reducing the risk of disease progression or death by 42 percent (p=0.0001). Patients receiving MabCampath also exhibited higher overall and complete response rates with a manageable safety profile, compared to patients who were treated with chlorambucil. Results from this study also demonstrated that patients treated with MabCampath achieved extended treatment-free intervals, with a median period of two years before requiring additional therapy.
Based on these data, the US Food and Drug Administration approved a supplemental Biologics License Application (sBLA) for Campath® (alemtuzumab) as a first-line, single-agent B-CLL treatment in September 2007. Campath is the trademark name for MabCampath in the US.
About Chronic Lymphocytic Leukemia
CLL is the most prevalent form of adult leukemia, affecting approximately three out of every 100,000 people in the Western hemisphere. The disease is most commonly diagnosed among people age 50 or older and is characterized by the accumulation of functionally immature white blood cells (lymphocytes) in the bone marrow, blood, lymph tissue, and other organs. Two types of lymphocytes are present in the blood, B cells and T cells. The majority of this patient population (95%) suffers from a subtype called B-cell chronic lymphocytic leukemia, or B-CLL. Because these cancerous B cells have a longer than normal life span, they begin to build up and “crowd out” the normal, healthy blood cells. The accumulation of functionally immature cells in the bone marrow excludes the generation of healthy cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, fevers, and decreased appetite and weight loss. Bone marrow infiltration leads to a lack of healthy blood cells, thus leading to fatigue, susceptibility to bleedings and weakening of the immune system, exposing the patient to a higher risk of infection.
MabCampath works in an entirely different way than chemotherapy. MabCampath works by targeting CD52, an antigen found on the surface of B cells - the most common cells found in CLL. When MabCampath binds to this antigen, it activates the immune system to destroy these targeted cells, while sparing crucial stem cells.
Genzyme and Bayer Schering Pharma AG, Germany are developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany holds exclusive worldwide marketing and distribution rights to alemtuzumab and participates with Genzyme in the design of clinical protocols and conduct of activities for the development of alemtuzumab. The product was launched in its oncology indication in the U.S. in June 2001, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath®, and in Europe, where it is named MabCampath®, in August 2001.
One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
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