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Lung Cancer Patients May Benefit From More Time Without Life-Threatening Chemotherapy Side Effects

INDIANAPOLIS, November 1 -- New data presented today confirm that advanced lung cancer patients can look forward to better-quality survival when treated with Alimta(R) (pemetrexed), a newly approved anticancer agent in the European Union compared with Taxotere(R) (docetaxel). Eli Lilly and Company announced the results of this analysis today at the 29th annual European Society for Medical Oncology meeting in Vienna, Austria.

"Patients suffer from two things, the cancer and chemotherapy side effects. They do not want to live their lives from doctors' clinics or hospital beds -- that's what makes these data so meaningful," said Jean-Louis Pujol, M.D., head of the department of thoracic oncology, Montpellier Academic Hospital, France. "These results reinforce Alimta as a major step forward in treating lung cancer patients in the second-line setting."

The results were gathered from a Phase III global clinical trial that showed Alimta provided survival comparable to that of Taxotere, the only other drug approved in this patient population, but with a more favorable side-effect profile in previously treated patients with advanced non-small-cell lung cancer.(1) A retrospective analysis of these data was introduced to measure the toxicity-free survival of the two therapies. Grade 4 toxicity-free survival time was measured from the time between a patient's trial enrollment date to the first recorded date of any Grade 4 toxicity or death. Alimta showed a Grade 4 toxicity-free survival time that was significantly better than Taxotere (median 7.5 versus 2.3 months, respectively). This means that patients treated with Alimta benefited from more time without life-threatening side effects than those treated with Taxotere -- a three-fold improvement. This difference was statistically significant.

"Physicians closely monitor for Grade 4 haematological toxicities when treating advanced lung cancer patients because these side effects can easily lead to life-threatening events such as infections or hemorrhages," said Pujol. "It is clear that Alimta offers a positive perspective on cancer therapy -- challenging the belief that critical side effects are the 'physical' price that must be paid for efficacy."

In the study, the main contributor to Grade 4 toxicities was neutropenia, which is a decrease in infection-fighting white blood cells that can lead to infection, with 1.9 percent of Alimta patients versus 31.5 percent of Taxotere patients being affected.

Overall, there were more Grade 4 toxicities in the Taxotere arm, including febrile neutropenia (0.8 for Alimta versus 2.5 percent for Taxotere), infections (0 for Alimta versus 1.1 percent for Taxotere), fatigue (0 for Alimta versus 0.4 percent for Taxotere), painful breathing or shortness of breath (0 for Alimta versus 0.7 percent for Taxotere) and pulmonary toxicity (0 for Alimta versus 0.7 percent for Taxotere). There were two Grade 4 toxicities where Alimta toxicities were higher: anemia (1.5 for Alimta versus 0 percent for Taxotere) and Alanine Transaminase (ALT) elevation, a laboratory measurement of liver function (0.4 Alimta versus 0 percent for Taxotere). The study also evaluated Grade 3/4 toxicities with similar results. Grade 3 toxicities are those that are severe but not as life threatening as Grade 4. The Grade 3/4 toxicity-free median survival for Alimta was 1.2 months compared with Taxotere at 0.4 months. This difference was statistically significant.

In September 2004, Alimta was approved by the European Commission for two distinct cancer indications. Alimta was approved as a single-agent therapy for patients with locally advanced or metastatic non-small cell lung cancer after previous chemotherapy. Alimta was also approved in combination with cisplatin, a common chemotherapy agent, for the treatment of malignant pleural mesothelioma, a cancer in the lining of the lungs, for patients who have not received prior chemotherapy and are not candidates for surgery. The administration for Alimta is a convenient 10-minute infusion, once every three weeks.

Alimta in Non-Small Cell Lung Cancer

According to the 2003 World Health Organization Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for both men and women. There will be 1.2 million cases diagnosed this year around the world.

Alimta was studied in a Phase III global clinical trial involving 571 randomized patients whose non-small cell lung cancer advanced beyond the first chemotherapy regimen. In this study Alimta and Taxotere showed similar survival time (median 8.3 versus 7.9 months, respectively) and progression-free survival (both 2.9 months).(1) Alimta caused significantly less neutropenia and hospitalization due to neutropenia with fever, as well as less hair loss compared with Taxotere. The ALT elevation was higher for Alimta (0.4 Alimta versus 0 percent for Taxotere). When Alimta is given as a single agent, the most common side effects include disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, rash and desquamation (peeling of the skin). Refer to the Summary of Product Characteristics (SPC) for complete information on the efficacy and side-effect profile of Alimta.

Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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.

This press release contains forward-looking statements about the potential of Alimta for the treatment of non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Alimta(R) (pemetrexed, Lilly)

Taxotere(R) (docetaxel, Aventis)

(1) Hanna N, Shepherd FA, Fossella FV, et al. Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients with Non-Small Cell Lung Cancer Previously Treated with Chemotherapy. Journal Clinical Oncology, Vol. 22, pp. 1589-1597; May 1, 2004.

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Eli Lilly and Company

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