PRINCETON, N.J., Dec. 28 /PRNewswire-FirstCall/ -- Today, Bristol-Myers Squibb Company 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.
Bristol-Myers Squibb Company
CONTACT: Media: Kathy Baum, Communications, +1-609-252-4227, or MadelineMalia, Communications, +1-609-252-3347, or Investors: John Elicker,Investor Relations, +1-212-546-3775, or Blaine Davis, Investor Relations,+1-212-546-4631, all of Bristol-Myers Squibb Company
Web site: http://www.bms.com/
