FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
20 Septembre 2007 - 3:00PM
PR Newswire (US)
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 DATASOURCE: Genzyme Corp. and Bayer HealthCare
Pharmaceuticals Inc. 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
Web site: http://www.genzyme.com/ http://www.campath.com/ Company
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