Clinical Trial Communication Commitment

Communicating timely, accurate and meaningful information about clinical trials that Bristol-Myers Squibb initiates for its investigational compounds and marketed products, as well as, sharing the results obtained for its marketed medicines is an essential component of our corporate mission to extend and enhance human life. Through our commitment to communicating this information, Bristol-Myers Squibb is fulfilling our pledge to all of our constituents to provide greater transparency into our drug development process.

Communicating About Clinical Trials

Bristol-Myers Squibb will continue to look for innovative ways to inform the global public about the registration of, and results from, its company-sponsored trials. The company recently developed and launched a website to supplement www.clinicalstudyresults.org and www.clinicaltrials.gov for the centralized reporting of information related to Bristol-Myers Squibb Company-sponsored clinical trials including registration and results. It can be accessed at http://ctr.bms.com/ctd/start.do.

The creation of this web resource, in conjunction with our policy to disclose all appropriate and meaningful clinical trial results to the PhRMA site, and to register new, currently enrolling trials to the National Institute of Health (NIH) website, demonstrates Bristol-Myers Squibb’s commitment to transparency into the development of our medicines.

Clinical Trial Registration

Earlier this year, the European, International and the Japanese pharmaceutical manufacturers associations joined with PhRMA in declaring a Joint Industry position on clinical trial information, emphasizing the pharmaceutical industry’s commitment to increase transparency of clinical trials through the broader use of clinical trial registries. Bristol-Myers Squibb has adopted as our corporate policy the principles of this joint position to provide patients, physicians and others with information about ongoing company-sponsored clinical trials that are open and recruiting patients.

Bristol Myers-Squibb posts our clinical trial registration information on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. Since the site’s inception, Bristol-Myers Squibb has registered over 300 company-sponsored trials, among the most in the industry. Above and beyond this basic requirement, Bristol-Myers Squibb voluntarily registers all of its clinical trials beginning with Phase II, regardless of the disease area, as we believe that this information should be accessible to the public. Taking this commitment even further, Bristol-Myers Squibb is working to ensure that all company-sponsored, non-U.S. clinical trials, which meet the above criteria, will be registered at appropriate international or local country registries.

The company has also increased the amount of descriptive information provided about each study at the time of registration in accordance with the recent recommendations by the World Health Organization and International Committee of Medical Journal Editors. The additional information includes the official scientific name of the trial, primary and secondary outcomes measures, type of interventions, and target number of patients in the trial (sample size).

In addition, Bristol-Myers Squibb will provide copies of the original study protocols and amendments when requested by the journal editors.

Clinical Trial Results Disclosure

Bristol-Myers Squibb adopted the voluntary principles issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) on the conduct of clinical trials and the communication of clinical trial results. Consistent with these principles, we will continue to report meaningful clinical trial results in an objective, accurate, balanced, and complete manner regardless of outcome. To support these principles, PhRMA has created a centralized website, www.clinicalstudyresults.org that provides public access to results of hypothesis-testing studies on marketed medicines. Bristol-Myers Squibb is fully supportive of this effort and was one of the first companies to post results to this site. The company has posted trial results or references to publications for company-sponsored trials, in accordance with the original PhRMA principles and other international association principles for medicines marketed outside the U.S.

Bristol-Myers Squibb hereby commits itself to go above and beyond the PhRMA principles by expanding the clinical trial results that we disclose. Going forward, our commitment is to disclose results on any Bristol-Myers Squibb-sponsored clinical trials conducted in patients, regardless of development phase or outcome, for the company’s marketed medicines. To that end, at the time of launch for new medicines, Bristol-Myers Squibb will post the results or reference the publication status for completed clinical trials conducted in patients for the new medicine. We also will disclose, on a timely basis, the results of all Bristol-Myers Squibb-sponsored clinical trials in patients that complete post-launch. In addition, for our investigational compounds, Bristol-Myers Squibb provides comprehensive data to all physicians conducting clinical trials via detailed investigator brochures, ensuring they are educated on the safest, most effective use of investigational compounds.

Demonstrating our commitment to these principles, we have already posted, for the medicines on the PhRMA website, clinical trial results for studies which completed prior to October 2002. These include pivotal trials and studies providing important information about the benefit/risk balance for our medicines, including currently approved and potential new uses, as well as new dosing information.