News Release

Alimta Approved in the European Union for Two Cancer Indications

September 22, 2004

First and Only Chemotherapy Approved for Malignant Pleural Mesothelioma
and New Option for a Common Form of Lung Cancer

Lilly announced today that its chemotherapy agent, Alimta^® (pemetrexed), has been granted marketing authorization by the European Commission (EC) for two distinct cancer indications.  This regulatory first for Lilly, means that Alimta can be offered to two patient groups each battling devastating forms of cancer. The product launch and availability of Alimta will vary in each European Member State.

Alimta, in combination with cisplatin, now becomes the first and only approved chemotherapy in the European Union to help patients with malignant pleural mesothelioma live longer¹. Alimta, given as a single agent, is also an important new second-line treatment for patients suffering from non-small cell lung cancer.²

"Alimta represents a true breakthrough in cancer care pushing the boundaries of conventional therapies with an innovative scientific approach. Alimta provides efficacy and when given with folic acid and B12 offers controlled side effects. Vitamin supplementation helps patients remain healthy enough to complete the full-recommended course of therapy - increasing the opportunity Alimta has to work," said Christian Manegold, M.D., Professor at Ruprecht-Karls-University and a consultant in Hematology/Oncology for the Thoracic Hospital in Heidelberg, Germany. "By providing a balance of proven efficacy and controlled side effects, Alimta will help positively change the way chemotherapy is perceived."

Cytotoxic chemotherapy, which kills cells to combat cancer, has been the foundation of advanced cancer therapy for decades. Alimta, a cytotoxic chemotherapy, is a novel multitargeting antifolate that simultaneously blocks at least three separate enzymes essential to the survival of cancer cells. A team of researchers led by Lilly discovered that vitamin supplementation of folic acid and B12 given with Alimta significantly reduces the frequency and severity of the drug's side effects without compromising its ability to kill cancer cells.

Specifically, Alimta was approved today in combination with cisplatin, a common chemotherapy agent, for the treatment of malignant pleural mesothelioma (MPM), a cancer in the lining of the lungs for patients who have not received prior chemotherapy and are not candidates for surgery. Alimta was also approved as a single agent therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after previous chemotherapy. The administration for Alimta is a convenient 10-minute infusion, once every three weeks.

"We are extremely pleased by the European Commission's approval of Alimta in Europe. This is an historical day - two patient groups benefit from today's approval," said Edmundo Muniz, M.D., oncology platform team leader at Lilly.  "We now have a very strong non-small cell lung cancer franchise led by Gemzar in the first-line metastatic setting and Alimta in the second-line metastatic setting. Oncology is an area of tremendous unmet medical need, and we are committed to being a leader in developing new therapies for patients. "

Clinical research of Alimta is ongoing in first-line non-small cell lung cancer, and in small cell lung, breast, colon, ovarian and gastric cancers and in combination with radiation.

Alimta for Malignant Pleural Mesothelioma Patients
Malignant pleural mesothelioma is a rare cancer of the lining of the lungs. The disease is often associated with asbestos exposure and has a long latency period - usually between 20 and 40 years. Most people are not diagnosed until the cancer is in advanced stages and treatment with surgery or radiation is not an option. It is estimated that between 10,000 and 15,000 people around the world are diagnosed annually with malignant pleural mesothelioma.

The now approved combination of Alimta and cisplatin was compared to cisplatin alone in a clinical trial of 448 patients from 19 countries - the largest trial to date among patients with malignant pleural mesothelioma. Results showed overall survival increased 30 percent (12.1 months for Alimta/cisplatin versus 9.3 months for cisplatin alone), and that 50.3 percent of patients treated with Alimta/cisplatin were alive a year later compared to 38.0 percent treated with cisplatin alone¹. Both the median and one-year advantages seen with the combination regimen of Alimta plus cisplatin were statistically significant.

The most common side effects when Alimta is used in combination with cisplatin are disorders of the blood and lymphatic system, gastrointestinal disorders, fatigue, sensory disorders of the nervous system, renal and urinary disorders, rash and hair loss.

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. The number of patients receiving treatment beyond the first-line in non-small cell lung cancer is steadily increasing and new therapy options are desperately needed in this setting.

Alimta was studied in a Phase III global clinical trial, the largest ever reported in second-line NSCLC, involving 571 randomized patients whose non-small cell lung cancer advanced beyond the first chemotherapy regimen. Among the patients enrolled in this study, 288 received docetaxel (75 mg/m2 on day one of a 21-day cycle; one-hour infusion) and 283 received Alimta (500 mg/m2 on day one of a 21-day cycle; 10-minute infusion; supplemented with vitamin B12 and folic acid).  The primary endpoint was overall survival and secondary endpoints included toxicity, response rate, and progression-free survival.

In this study Alimta showed a survival rate comparable to that of docetaxel but with a more favorable side effect profile. Alimta caused significantly less neutropenia (an abnormal decrease in white blood cells) and hospitalization for neutropenia with fever, as well as less hair loss compared to docetaxel.

Patients on Alimta compared to therapy with docetaxel did show an increased transient elevation in Alanine Transaminase (ALT), a laboratory measurement of liver function. 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).

Key study findings are as follows:

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.

Lilly Oncology
Lilly Oncology is a world leader in cancer research and treatment, with therapies that are considered a standard of care in a number of difficult-to-treat tumor types built upon a vibrant and cutting edge research platform driving therapeutic innovation. Lilly Oncology is committed to delivering realistic solutions to physicians, patients and payers that materially improve the course of cancer care.  With a promising pipeline of innovative products built on strong scientific foundations, Lilly strives to continually find ways to offer hope in the way of answers for patients.

This press release contains forward-looking statements about the potential of Alimta for the treatment of malignant pleural mesothelioma and 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.

1. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma.  J Clin Oncol 21:2636-2644, July 15 2003.
2. 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.