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| |  ASCO: Aromasin (Exemestane) May Extend Tumor-Free Period in Advanced Breast Cancer NEW ORLEANS, LA -- May 24, 2000 -- Initial data from a Phase II study in the first-line treatment of advanced breast cancer in postmenopausal women taking Aromasin® (exemestane tablets) suggests that Aromasin may extend the time that patients remain free of tumor growth compared to tamoxifen. Tamoxifen is currently the hormonal agent of choice for first-line treatment of advanced breast cancer. The results from this study were presented at the annual meeting of the American Society of Clinical Oncology (ASCO). The study compared the activity and safety of Aromasin (25 mg/day), developed and marketed by Pharmacia Corporation, with tamoxifen (20 mg/day) as first-line hormonal therapy in postmenopausal women with advanced breast cancer. Of 97 randomized patients, data are available on 63 for response and 76 for toxicity. In the study, the median time to tumor progression in patients treated with Aromasin was 8.9 months compared with 5.2 months in patients treated with tamoxifen. "These preliminary results are striking," says Robert J. Paridaens, M.D., Ph.D., professor and head of medical oncology clinic, University Hospital Gasthuisberg, Catholic University Leuven, Leuven, Belgium. "The data suggest that Aromasin challenges the standard of care, which may be confirmed by moving to a phase III trial involving a larger number of patients in order to allow a true and statistically valid comparison." Aromasin is indicated for the treatment of advanced breast cancer in postmenopausal women whose tumors have stopped responding to anti-estrogen therapy such as tamoxifen. It is the first in a new class of oral hormonal inactivator therapies. These compounds work by selectively targeting and irreversibly binding to the aromatase enzyme, which is required to produce estrogen. Some breast cancer cells need estrogen to survive. Once the drug binds to an enzyme, that enzyme can not make estrogen again. Aromasin interferes with the supply of estrogen to cancerous cells and prevents the cells from continuing to grow. It differs from other aromatase inhibitors due to this irreversible binding. This unique mechanism of action and other clinical trial results to date prompted the European Organization for Research and Treatment of Cancer (EORTC) to conduct this Phase II study. Based on the initial results presented today, the EORTC initiated a large Phase III trial of identical design. A National Surgical Breast and Bowel Project (NSABP) study of Aromasin will be initiated in mid-2000. In addition, Aromasin is being studied for chemoprevention. Aromasin was well tolerated in this trial. Women treated with Aromasin experienced the following side effects in comparison to those treated with tamoxifen: grade 2/3 fatigue (5 percent vs. 13 percent), pain (11 percent vs. 18 percent), hot flushes (3 percent vs. 15 percent), sweating (0 vs. 10 percent), edema (3 percent vs. 8 percent), nausea (3 percent vs. 8 percent) and dyspnea (11 percent vs. 5 percent) than did women treated with tamoxifen. There was no difference between patients treated with Aromasin and tamoxifen in the incidence of weight gain (5 percent, 5 percent). Pharmacia Corporation gained approval of Aromasin by the U. S. Food and Drug Administration in the United States for Aromasin in the fourth quarter of 1999. Aromasin is currently available in Switzerland, the United Kingdom, Germany and the Nordic nations. Pharmacia Corporation anticipates Aromasin to be available in France, Italy, the Netherlands, Belgium, Spain, Portugal and Latin America by the middle of this year. Pharmacia Oncology is bringing discovery to life for every person touched by cancer. The current oncology portfolio includes Camtposar® (irinotecan hydrochloride injection), Aromasin(R) (exemestane tablets); Ellence™/Farmorubicin® (epirubicin hydrochloride injection); Idamycin® (idarubicin hydrochloride injection); and Zinecard® (dexrazoxane injection). Products in development include signaling inhibitors SU5416 and SU6668 and other compounds for the treatment of patients with cancer occurring in various forms. Celecoxib, a COX-2 specific inhibitor is currently in clinical trials to investigate its role in inhibiting the formation of colorectal cancer cells. Celebrex™ (celecoxib capsules), has been approved to reduce the number of adenomatous colorectal polyps in patients with familial adenomatous polyposis (FAP) as an adjunct to usual care (endoscopic surveillance and surgery). Celecoxib is also being investigated across a variety of human tumors. Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia has a broad product portfolio, a robust pipeline of new drugs, and an annual investment of more than $2 billion in pharmaceutical research and development. Related Link: Pharmacia Corporation.
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