PRINCETON, N.J., June 19 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb
(NYSE: BMY) announced today that the U.S. Food and Drug Administration
(FDA) has accepted, for filing and review, the New Drug Application (NDA)
for the investigational compound ixabepilone, an epothilone B analog. The
proposed indications for ixabepilone are as a monotherapy to treat patients
with metastatic or locally advanced breast cancer after failure of an
anthracycline, a taxane, and capecitabine and in combination with
capecitabine to treat patients with metastatic or locally advanced breast
cancer after failure of an anthracycline and a taxane. Currently, there are
few proven treatment options available to patients with breast cancer whose
disease has rapidly progressed through or whose disease is not responding
to prior treatment with chemotherapies (anthracycline and taxane).
Bristol-Myers Squibb also announced that the NDA has been granted
priority review. The target action date is in late October.
About Ixabepilone
Ixabepilone is an investigational compound, a semisynthetic analog of
epothilone B, designed to inhibit or prevent the growth or development of
cancer cells. Epothilones and their analogs are a potential new class of
antineoplastic, chemotherapy agents. For information on ixabepilone
clinical trials, log on to http://www.clinicaltrials.gov.
About Breast Cancer
The American Cancer Society estimates that more than 180,000 new cases
of breast cancer will be diagnosed in the United States this year, and
almost 41,000 people will die from the disease. Metastatic breast cancer is
the most advanced form of the disease in which the cancer has spread to
other organs in the body. Unlike cancer that has remained contained in the
breast and surrounding lymph nodes, once the cancer has spread to other
organs, the disease cannot be cured; however, it can be treated.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com.
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among other
risks, there can be no guarantee that the application will be approved, or,
if approved, that the product will be commercially successful.
Forward-looking statements in this press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
SOURCE Bristol-Myers Squibb
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Related links:
http://www.bms.com
http://www.clinicaltrials.gov
CONTACT:
Media, Madeline Malia, Communications,
office, +1-609-252-3347, cell, +1-609-651-1323,
madeline.malia@bms.com, or Tony Plohoros, Communications, office,
+1-609-252-7938, cell, +1-908-591-2839, tony.plohoros@bms.com; or
Investors, John Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, all for Bristol-Myers Squibb
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