Over the next 12 months, Bristol-Myers Squibb Company plans to submit an unprecedented number of regulatory submissions, including global regulatory filings for five new potential blockbuster compounds.

At a company presentation of its research pipeline to the Wall Street investment community, Bristol-Myers Squibb executives also shared new details about some of the more than 50 compounds in the company's extensive early and late-stage pipeline and provided highlights of a selection of its more than 100 drug discovery programs.

"Our 'Strategy for Growth' plan, which was announced just one year ago, has already delivered significant results," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "During the past year, the company has been quite visible in the area of acquisitions and divestitures. The organization has also been aggressively focused on efforts to accelerate and enrich our future pipeline. As a result of these efforts, we believe we have the products that will allow us to achieve our goal of launching three potential blockbuster products a year for several years starting in 2003 and we are hopeful that the first of these products may launch in 2002."

Within the next 12 months, Bristol-Myers Squibb expects to submit global regulatory filings for the following potential best-in-class or first-in-class products:

Aripiprazole - Aripiprazole is a novel and potentially best-in-class compound under investigation for the treatment of schizophrenia and related disorders. Aripiprazole is a next-generation antipsychotic that, in completed trials, has demonstrated efficacy with an excellent safety and tolerability profile and once-daily dosing with no need for titration in Phase III clinical studies. During the meeting, Bristol-Myers Squibb executives announced that the company had submitted the New Drug Application (NDA) for aripiprazole on October 31, 2001. The company also plans to submit for filing the Marketing Authorisation Application (MAA) in Europe by the end of 2001.

Erbitux - Erbitux (cetuximab), formerly known as IMC-C225, is a first-in-class monoclonal antibody that is being co-promoted and co-developed with ImClone Systems. In clinical studies, the compound has demonstrated activity in patients with refractory tumors who have failed to respond to other treatment options and is being developed for initial use in treating advanced colorectal cancer. Bristol-Myers Squibb and ImClone Systems are also exploring the potential of Erbitux in treating other tumor types including refractory head and neck tumors and pancreatic cancer. ImClone Systems completed the submission of the Biologics License Application (BLA) for Erbitux, for the treatment of advanced colon cancer that is refractory to irinotecan, late last week.

Vanlev - Vanlev (omapatrilat) is a novel NEP/ACE inhibitor that may offer a treatment alternative for people worldwide who suffer from high blood pressure. Vanlev is also being developed as a potential treatment for congestive heart failure. The company previously announced plans to re-submit the filing of the Vanlev NDA for hypertension by the end of 2001.

Atazanavir - Atazanavir has the potential to become the best-in-class protease inhibitor. The compound would be the only protease inhibitor to be taken orally once-a-day. In studies completed to date, atazanavir has a favorable HIV resistance and lipid profile and, unlike other protease inhibitors, has not been associated with elevated lipid levels. With the addition of atazanavir, the Bristol-Myers Squibb virology portfolio would have once-a-day therapies in each antiretroviral class. Bristol-Myers Squibb plans to complete the global regulatory submissions for atazanavir by the second half of 2002.

Desquinolone - Des-6-fluoroquinolone is a novel quinolone antibiotic that, based on studies completed to date, has demonstrated excellent safety and resistance profiles. The company plans to complete the des-6-fluoroquinolone global regulatory submissions for multiple indications in the second half of 2002.

"The next 12 months will be the most prolific period in Bristol-Myers Squibb discovery and development history," said Peter S. Ringrose, chief scientific office, and president, Bristol-Myers Squibb Pharmaceutical Research Institute. "The company has made remarkable advancements in discovery and development that have produced a robust pipeline with the potential to deliver a record number of potential best-in-class and first-in-class products faster than ever before. We have already tripled the number of compounds that are in full or late-stage development."