Study Data Demonstrated Improved Progression-free Survival with Campath
CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ --
Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare Pharmaceuticals Inc.
(NYSE: BAY) 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
SOURCE Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc.
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Related links:
http://www.genzyme.com
http://www.campath.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Genzyme Contacts, media, Maria Cantor,
+1-617-768-6690, or investors, 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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