Bristol-Myers Squibb Submits New Drug Application for Dasatinib

Posted by rob on December 29, 2005 under Uncategorized | Be the First to Comment

PRINCETON, N.J., Dec. 28 /PRNewswire-FirstCall/ — Today, Bristol-Myers

Squibb Company (NYSE: BMY) announced that the Company has completed the

rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug

Administration (FDA) for dasatinib to treat chronic myelogenous leukemia (CML)

in chronic, accelerated or blast phases, as well as Philadelphia chromosome-

positive (Ph+) acute lymphoblastic leukemia (ALL).

The NDA seeks approval of dasatinib – an investigational multi-targeted

kinase inhibitor – to treat adult CML and Ph+ ALL patients with resistance or

intolerance to prior therapy.

Dasatinib was discovered and is being developed by scientists within

Bristol-Myers Squibb laboratories.

About CML and ALL

CML is a slowly progressing cancer of the blood and bone marrow that

usually occurs during or after middle age and rarely occurs in children. ALL

is a rapidly progressing cancer of the blood and bone marrow that usually

occurs in children; although it can occur at any age. The Leukemia and

Lymphoma Society estimates that 4,600 new cases of CML and nearly 4,000 new

cases of ALL will be diagnosed in the United States this year.

About the Philadelphia Chromosome

Approximately 95 percent of people with CML and approximately 25 percent

of adults with ALL have a gene mutation called the Philadelphia chromosome, in

which part of the DNA from one chromosome (chromosome 9) moves to another

chromosome (chromosome 22). This translocation brings together two genes, one

from each chromosome: BCR (breakpoint cluster region) and ABL (Ableson

leukemia virus). The resulting hybrid gene, BCR-ABL, produces an abnormal

protein called Bcr/Abl tyrosine kinase that triggers uncontrolled cell growth.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development, and

exhaustive exploration of innovative cancer fighting therapies that extend and

enhance the lives of patients living with cancer. More than 40 years ago,

Bristol-Myers Squibb built a unified vision for the future of cancer

treatment. With expertise, dedication and resolve, that vision led to the

development of a diverse global portfolio of anti-cancer therapies that are an

important cornerstone of care today. Hundreds of scientists at Bristol-Myers

Squibb’s Pharmaceutical Research Institute are studying ways to improve

current cancer treatments and identify better, more effective medicines for

the future.

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. 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 dasatinib will

receive regulatory approval or, if approved, 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, 2004

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 Company

Web Site: http://www.bms.com

Bristol-Myers Squibb Submits New Drug Application for Dasatinib