CAMBRIDGE, Mass. and BERLIN /PRNewswire-FirstCall/ -- 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). 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.
Genzyme(R), Campath(R) and MabCampath(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.
Bayer HealthCare press releases and other information is available at
pharma.bayer.com or by calling 1-888-84BAYER
Genzyme Contacts: Bayer HealthCare Media Contacts:
Maria Cantor (media) Kimberly Wix (US media)
(617) 768-6690 (973) 305-5258
Carol Miceli (investors) Jost Reinhard (ex-US media)
(617) 768-6602 +49 30 468 15062
SOURCE Genzyme Corp.
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http://www.genzyme.com
http://pharma.bayer.com
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CONTACT:
Genzyme: Maria Cantor, media,
+1-617-768-6690, or Carol Miceli, investors, +1-617-768-6602; or
Bayer HealthCare Media: Kimberly Wix, US media, +1-973-305-5258,
or Jost Reinhard, ex-US media, +49 30 468 15062
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