Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare announced today that a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) has been submitted to the U.S. Food and Drug Administration (FDA) to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL).
CAMBRIDGE, MA, USA and BERLIN, Germany | Apr 4, 2007 | Genzyme Corp. and Bayer HealthCare announced today that a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) has been submitted to the U.S. Food and Drug Administration (FDA) to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme intends to make a similar filing in Europe within the next couple of weeks to support this label expansion.
The product is marketed outside the United States as MabCampath(R), by Bayer Schering Pharma AG, Germany and in the U.S. by the company’s US affiliate, Bayer HealthCare Pharmaceuticals, as Campath. A label expansion to include first-line therapy would significantly increase the number of potential patients for whom Campath would be indicated.
"Submission of this sBLA is based on positive data from a phase III clinical trial, which showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared to chlorambucil," stated Mark Enyedy, senior vice-president and general manager of Genzyme’s oncology business unit. "We are very excited about the potential use of Campath in treating patients earlier in the course of their disease, and about making a very important difference in battling leukemia."
"In addition to the filing to expand the product’s label, we will continue focusing our efforts on further exploring the full potential of Campath in high risk CLL, combination and consolidation therapy, and in seeking approval for treatment via subcutaneous administration," stated Gunnar Riemann, PhD, Member of the Board Management of Bayer Schering Pharma AG, Germany.
The phase III study was an international, randomized, controlled clinical trial conducted to satisfy a post-approval commitment to the FDA to demonstrate clinical benefit of Campath in B-CLL, and to complete the conversion to regular approval. This confirmatory study was completed in accordance with timelines committed to the FDA by Genzyme.
About Chronic Lymphocytic Leukemia
CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 people in Europe and the United States. The disease is most commonly diagnosed among people age 50 or older. CLL 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. About 95 percent of CLL cases involve cancerous B cells. Because these 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 inhibits 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.
About Campath
Campath received accelerated approval in 2001 and this first-line, randomized study was the primary post-approval commitment study designed to support regular approval. Campath is currently indicated for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Determination of the effectiveness of Campath is based on overall response rates. Comparative, randomized trials demonstrating increased survival or clinical benefit such as improvement in disease-related symptoms have not yet been conducted.
Campath works by targeting the "CD52" antigen, which is one of the most common antigens found on B and T cells. When Campath binds to this CD52 antigen, it activates the immune system to destroy targeted cells not only in the blood but also in the bone marrow. Campath is not currently indicated as a first-line treatment in CLL.
Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Campath has a boxed warning which includes events of hematologic toxicity, infusion reactions, and infections/opportunistic infections.
Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type 1 hypersensitivity or anaphylactic reactions to Campath or to any one of its components.
The most commonly reported infusion-related adverse events were rigors, drug-related fever, nausea, vomiting, and hypotension. Hematologic toxicities included pancytopenia/marrow hypoplasia, anemia, thrombocytopenia, neutropenia, and profound lymphopenia, and should be monitored. Infections reported included sepsis, pneumonia, and opportunistic infections such as CMV, candidiasis, aspergillosis, and mucormycosis.
Genzyme and Bayer HealthCare are co-developing Campath in oncology and other indications.
About Genzyme
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 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been 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.
About Bayer HealthCare
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This press release contains forward-looking statements, including statements about the regulatory plans and timing for, and the expansion of, the Campath product label into earlier-line CLL. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the actual efficacy and safety of Campath in earlier-line CLL; the actual timing and content of submissions to and decisions made by the U.S. Food and Drug Administration and other regulatory authorities, and the other risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission. Please see the disclosure under the heading "Risk Factors" in the Management’s Discussion and Analysis of Genzyme Corporation and Subsidiaries’ Financial Condition and Results of Operations section of Genzyme’s Annual Report on Form 10-K for the year ended December 31, 2006 for a more complete discussion of these and other risks. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
SOURCE: Genzyme Corp. and Bayer
Post Views: 160
Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare announced today that a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) has been submitted to the U.S. Food and Drug Administration (FDA) to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL).
CAMBRIDGE, MA, USA and BERLIN, Germany | Apr 4, 2007 | Genzyme Corp. and Bayer HealthCare announced today that a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) has been submitted to the U.S. Food and Drug Administration (FDA) to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme intends to make a similar filing in Europe within the next couple of weeks to support this label expansion.
The product is marketed outside the United States as MabCampath(R), by Bayer Schering Pharma AG, Germany and in the U.S. by the company’s US affiliate, Bayer HealthCare Pharmaceuticals, as Campath. A label expansion to include first-line therapy would significantly increase the number of potential patients for whom Campath would be indicated.
"Submission of this sBLA is based on positive data from a phase III clinical trial, which showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared to chlorambucil," stated Mark Enyedy, senior vice-president and general manager of Genzyme’s oncology business unit. "We are very excited about the potential use of Campath in treating patients earlier in the course of their disease, and about making a very important difference in battling leukemia."
"In addition to the filing to expand the product’s label, we will continue focusing our efforts on further exploring the full potential of Campath in high risk CLL, combination and consolidation therapy, and in seeking approval for treatment via subcutaneous administration," stated Gunnar Riemann, PhD, Member of the Board Management of Bayer Schering Pharma AG, Germany.
The phase III study was an international, randomized, controlled clinical trial conducted to satisfy a post-approval commitment to the FDA to demonstrate clinical benefit of Campath in B-CLL, and to complete the conversion to regular approval. This confirmatory study was completed in accordance with timelines committed to the FDA by Genzyme.
About Chronic Lymphocytic Leukemia
CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 people in Europe and the United States. The disease is most commonly diagnosed among people age 50 or older. CLL 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. About 95 percent of CLL cases involve cancerous B cells. Because these 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 inhibits 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.
About Campath
Campath received accelerated approval in 2001 and this first-line, randomized study was the primary post-approval commitment study designed to support regular approval. Campath is currently indicated for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Determination of the effectiveness of Campath is based on overall response rates. Comparative, randomized trials demonstrating increased survival or clinical benefit such as improvement in disease-related symptoms have not yet been conducted.
Campath works by targeting the "CD52" antigen, which is one of the most common antigens found on B and T cells. When Campath binds to this CD52 antigen, it activates the immune system to destroy targeted cells not only in the blood but also in the bone marrow. Campath is not currently indicated as a first-line treatment in CLL.
Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Campath has a boxed warning which includes events of hematologic toxicity, infusion reactions, and infections/opportunistic infections.
Campath is contraindicated in patients who have active systemic infections, underlying immunodeficiency (e.g., seropositive for HIV), or known Type 1 hypersensitivity or anaphylactic reactions to Campath or to any one of its components.
The most commonly reported infusion-related adverse events were rigors, drug-related fever, nausea, vomiting, and hypotension. Hematologic toxicities included pancytopenia/marrow hypoplasia, anemia, thrombocytopenia, neutropenia, and profound lymphopenia, and should be monitored. Infections reported included sepsis, pneumonia, and opportunistic infections such as CMV, candidiasis, aspergillosis, and mucormycosis.
Genzyme and Bayer HealthCare are co-developing Campath in oncology and other indications.
About Genzyme
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 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been 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.
About Bayer HealthCare
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the US, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This press release contains forward-looking statements, including statements about the regulatory plans and timing for, and the expansion of, the Campath product label into earlier-line CLL. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the actual efficacy and safety of Campath in earlier-line CLL; the actual timing and content of submissions to and decisions made by the U.S. Food and Drug Administration and other regulatory authorities, and the other risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission. Please see the disclosure under the heading "Risk Factors" in the Management’s Discussion and Analysis of Genzyme Corporation and Subsidiaries’ Financial Condition and Results of Operations section of Genzyme’s Annual Report on Form 10-K for the year ended December 31, 2006 for a more complete discussion of these and other risks. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.
SOURCE: Genzyme Corp. and Bayer
Post Views: 160
