Oncology

At OSI, our established prowess as discoverers and developers of molecular targeted therapies – first in a 15-year alliance with Pfizer and now for five years on our own – has established us as leaders in a sea change in how cancer patients are treated. For example, unlike old-line, cytotoxic chemotherapy drugs, Tarceva is designed to target abnormalities in cancer cells and not the healthy cells around a tumor. By driving at a tumor’s underlying biology we have taken the first step in making cancer more of a chronic disease and less of a deadly one. With Tarceva, patients can retain their hair, and avoid mucositis and other side effects associated with injectable chemotherapies.

One of Tarceva’s foremost attributes is the fact that it can be taken in the comfort of the patient’s own home. As an oral, once-a-day therapy, it provides convenience and its generally well-tolerated side effects help improve patients’ quality of life.

Tarceva is designed to target signaling pathways that are involved in multiple cancers. Tarceva has now been approved for two distinct illnesses, NSCLC and pancreatic cancer. Approximately 151,800 U.S. cancer patients are diagnosed with NSCLC each year and a sizeable proportion of those are currently treated with additional pharmacotherapy following the failure of front-line chemotherapy regimens. According to the American Cancer Society, approximately 32,000 people died from pancreatic cancer in the U.S. last year, making pancreatic cancer the fourth leading cause of cancer death in America. Tarceva is the first drug to extend survival for pancreatic cancer patients in a decade.

We believe that, going forward, Tarceva will continue to emerge as a major product in the treatment of cancer. A number of factors should contribute to continued growth of Tarceva sales in 2006: continued uptake in the pancreatic market; the full European launch for NSCLC; improved penetration of the second-line NSCLC market (especially in patients with better performance status) and an improved Medicare reimbursement environment and general sales increase due to the advent of the Medicare Part D program in the U.S.

Our longer-term strategy for Tarceva is focused on progressing the medicine’s use to the front-line and adjuvant settings in NSCLC; expanding Tarceva use to other cancers; and exploring the use of Tarceva in combination with other targeted therapies. Phase II data has shown good activity for Tarceva in the front-line NSCLC setting. Anti-tumor activity has also been demonstrated in Phase II trials for ovarian, head and neck, brain, liver, breast and colon cancers.