CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath was initially approved in 2001 under accelerated approval regulations and the FDA has determined that the study results submitted in the sBLA fulfill the post- marketing commitment to verify clinical benefit. A label expansion is under consideration in Europe.
“Campath is clearly an important single agent for the first-line treatment of CLL,” said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United Kingdom, and the lead investigator of the pivotal study comparing Campath against chlorambucil. “We are excited to be entering an era where our improved understanding of CLL, coupled with more advanced laboratory tests and targeted therapy options like Campath, have dramatically changed the first- line treatment approach for this type of leukemia.”
Campath works in an entirely different way than chemotherapy, and is the first and only monoclonal antibody approved by the FDA for the treatment of B- CLL.
“The data that supported this label expansion add to a growing body of evidence about the effectiveness of Campath across the entire B-CLL treatment pathway,” stated Mark Enyedy, president of Genzyme’s oncology business unit. “A broader range of patients is now eligible for Campath treatment, regardless of whether they have received prior therapy. The approval also marks an important step in a long-term development plan that is exploring the full potential of Campath in high-risk CLL, combination and consolidation therapy.”
Presented at the 48th Annual Meeting of the American Society of Hematology (ASH) conference last year, data supporting the sBLA were part of an international Phase III clinical trial comparing Campath with chlorambucil in previously untreated patients with B-CLL. The study met its primary endpoint by demonstrating longer progression free survival (PFS) in patients treated with Campath versus chlorambucil, with Campath reducing the risk of disease progression or death by 42 percent (p=0.0001).
Patients receiving Campath exhibited higher overall and complete response rates that were statistically significant in comparison to patients who were treated with chlorambucil. Campath also demonstrated a manageable safety profile among study patients.
“We are excited that Campath can now be used to treat patients in the U.S. earlier in the course of their disease,” said Gunnar Riemann, Ph.D., member of the Board of Management of Bayer Schering Pharma AG. “The ability to now provide Campath as a first-line treatment of the disease will make an important difference in battling B-CLL. It may help patients by offering a potentially more effective treatment approach that can extend progression-free survival.”
Campath is marketed in the U.S. by Bayer HealthCare Pharmaceuticals Inc., as Campath, and outside the United States as MabCampath(R).
About B-Cell Chronic Lymphocytic Leukemia
According to the Leukemia and Lymphoma Society, approximately 15,000 new cases of B-cell chronic lymphocytic leukemia (B-CLL) are diagnosed in the U.S. each year. It is the largest subset of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia in the western world. B-CLL is characterized by the accumulation of functionally immature cells in the bone marrow, blood, lymph tissue and other organs. Because these cancerous B cells have a longer than normal life span, they begin to build up and “crowd out” normal, healthy blood 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 causing susceptibility to bleedings and weakening of the immune system, exposing the patient to a higher risk of infection.
Additional Information About Campath
Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath has a boxed warning which includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions are infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.
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 9,500 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.
Genzyme(R) and Campath(R) are registered trademarks of Genzyme Corporation. All rights reserved.
Genzyme’s press releases and other company information are available at http://www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
For more information about Campath, including full prescribing information, call 1-888-84-BAYER (1-888-842-2937) or visit http://www.campath.com.
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, high-risk CLL, and combination and consolidation therapy. 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 these indications; 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 under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Risk Factors” in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. 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.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments
Genzyme Contacts: Bayer Contacts: Maria Cantor (media) Kimberly Wix (media) (617) 768-6690 (973) 305-5258 Sally Curley (investors) Jost Reinhard (ex-US media) (617) 768-6140 +49-30-468-15062
Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc.
CONTACT: Genzyme Contacts, media, Maria Cantor, +1-617-768-6690, orinvestors, Sally Curley, +1-617-768-6140; or Bayer Contacts, media,Kimberly Wix, +1-973-305-5258, or ex-US media, Jost Reinhard,+49-30-468-15062
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