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Eli Lilly and Company: Fewer Side Effects Reduce Costly Supportive Care for Non-Small Cell Lung Cancer Patients

Survival Rate with Alimta(R) (pemetrexed) Similar to Taxotere(R) (docetaxel), But Investigational Drug's Side Effects Significantly Fewer

Source: COPENHAGEN, Denmark--(BUSINESS WIRE)

September 24, 2003. New data presented today at the 12th European Cancer Conference (ECCO) suggest that the investigational drug Alimta(R) (pemetrexed) offers non-small cell lung cancer (NSCLC) patients not only similar efficacy when compared to Taxotere(R) (docetaxel), but also reduced costs due to fewer side effects. These data, collected from an analysis of a Phase III study and applied to the United Kingdom's healthcare setting, show that treatment with Alimta resulted in fewer drug-related hospitalizations and unscheduled supportive care interventions. Recent data presented at the American Society of Clinical Oncology (ASCO) congress and featured as part of the Presidential Symposium at the World Congress on Lung Cancer (WCLC), indicated that previously treated NSCLC patients with recurrent disease who are treated with Alimta experienced similar survival to Taxotere, as well as similar time to disease progression and response rate. However, the data also showed that patients in the Alimta arm of the study experienced significantly fewer side effects, including a three-fold difference in

drug-related hospitalizations, than those receiving Taxotere.

"The benefits Alimta provides in terms of tolerability and reduced side effects are of key importance to thoracic cancer patients," said Dr. Michael Cullen, Cancer Centre at the Queen Elizabeth Hospital, Birmingham, United Kingdom. "Treatments like Alimta, that result in cost-benefit advantages, respond also to the needs of healthcare funders."

Data Results: Alimta versus Taxotere Cost Analysis

Data presented at ECCO assessed resource utilization in a multinational, Phase III randomized study of 541 patients comparing Alimta with Taxotere in patients with second-line NSCLC who had previously received chemotherapy. Direct medical costs -- as sourced by United Kingdom (UK) National Health Service (NHS) casemix data and UK national drug prices -- of key investigator-determined drug-related adverse events were reported for these two treatment groups, including hospitalizations, transfusions, erythropoietin, granulocyte colony-stimulating factors (GCSFs) and parenteral (injectable) antibiotics - commonly used supportive care for adverse events. Results showed that in the Alimta arm of the study, the total average cost-per-patient drug-related adverse events for Alimta was GBP 235, versus GBP 588 for Taxotere. Highlights from these results included a lower average hospitalization cost-per-patient, at GBP 75 for Alimta versus GBP 274 for Taxotere, and GCSF cost-per-patient at GBP 13 versus GBP 128.

Data Results: Alimta versus Taxotere in Second-Line Non-Small Cell Lung Cancer

In an international head-to-head study, Alimta showed similar survival with significantly fewer side effects when compared with Taxotere in patients with previously treated, recurrent NSCLC. Patients receiving Alimta had a median survival of 8.3 months compared with 7.9 months among Taxotere patients. Importantly, results showed a statistically significant difference in the incidence of severe neutropenia, a decrease in the number of white blood cells that increases the risk of infection (5 percent in the Alimta arm and 40 percent in the Taxotere arm (p= less than 0.001)). In addition, Alimta patients also experienced fewer cases of fever associated with neutropenia and subsequent hospitalizations, as well as fewer drug-related serious adverse events. All these differences in side effects reached statistical significance. Taxotere is approved for use in the treatment of first- and second-line NSCLC in the U.S., Europe and many other countries.

Eli Lilly and Company will complete its European and U.S. submissions for Alimta in both malignant pleural mesothelioma and second-line non-small cell lung cancer by the end of 2003.

Lilly, a leading innovation-driven corporation is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

Alimta(R) (pemetrexed, Lilly)

Taxotere(R) (docetaxel, Aventis Pharmaceuticals, Inc.)




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