This excerpt taken from the BMY 8-K filed Oct 28, 2005.
INCREMENTAL, TARGETED INVESTMENTS AND A ROBUST PIPELINE
Bristol-Myers Squibb is increasing investments behind targeted marketing programs for pharmaceutical products expected to drive future growth in serious disease areas with significant unmet medical need. For example, the company is complementing its efforts focused on high-value primary care physicians and specialists with direct-to-consumer marketing that includes expanded advertising for PLAVIX®, and the first-ever print ad campaign for ABILIFY®.
Bristol-Myers Squibb is also increasing research and development investments, in line with the low double-digit annual growth rate that continues to be planned for 2005. During the third quarter, among Bristol-Myers Squibbs full-development programs, ORENCIA®, a potential therapy for rheumatoid arthritis was recommended for approval by the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee and saxagliptin, the companys DPP4 inhibitor for the potential treatment of diabetes transitioned to Phase III.
As previously disclosed, on October 18, 2005, the FDA issued an approvable letter for PARGLUVA (muraglitazar), the companys investigational oral medicine for the treatment of type 2 diabetes. The FDA requested additional information from ongoing clinical trials to more fully address the cardiovascular safety profile of muraglitazar. Yesterday, Bristol-Myers Squibb announced that the company and its partner, Merck & Co., Inc., have determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because the ongoing trials were not designed to answer questions raised by the FDA. The additional studies could take approximately five years to complete. Bristol-Myers Squibb also announced yesterday that it agreed to begin discussions with Merck to terminate the companies collaborative agreement. Bristol-Myers Squibb will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of muraglitazar.
Looking ahead to December, Bristol-Myers Squibb plans to present Phase II data on dasatinib, a SRC/ABL Kinase Inhibitor being investigated for the treatment of chronic myelogenous leukemia (CML), at the American Society of Hematology (ASH) annual meeting. The company continues to expect a possible dasatinib filing in the next three months.