LILLY (ELI) & COMPANY: Gemzar Provides Significant Value

Abstract Numbers: 8092, 7215, 7227                                             

For Release: May 17, 2005, 8:00 a.m. EDT

Refer to: Gregory L. Clarke (U.S. Media) Carla L. Cox (non-U.S. Media)

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   New Data Show Gemzar®-Based Combination Therapies May Provide Significant   
           Clinical Value in Early-Stage Non-Small Cell Lung Cancer            

INDIANAPOLIS May 17, 2005 - Data presented today ,, from ongoing clinical
trials show that therapies based on Eli Lilly and Company's (LLY) Gemzar®
(gemcitabine, HCl) administered prior to surgery have a positive impact on
survival, tumor shrinkage and quality of life among patients with early-stage
non-small cell lung cancer (NSCLC). Gemzar, which is approved in various
countries for the treatment of lung, breast, pancreatic, bladder, ovarian and
cervical cancers, is one of the most highly studied anti-cancer agents in the
world and these findings add to the body of evidence of Gemzar's efficacy in
another stage of lung cancer.

The study results, presented at the 41st annual meeting of the American Society
of Clinical Oncology (ASCO), are part of the ongoing GINEST Project, which is a
dual-clinical trial project evaluating the effectiveness of Gemzar in
combination with other leading chemotherapy agents in the treatment of Stage I
or II non-small cell lung cancer.

'Unfortunately, the risk of recurrence of lung cancer is a major problem even
in early stages of the disease,' said Richard Gralla, M.D., president of the
New York Lung Cancer Alliance and a GINEST investigator. 'Traditionally,
treatment of Stage I or II non-small cell lung cancer has only involved
surgery. The goal of administering these regimens prior to surgery is to treat
any microscopic spread of disease and shrink the tumor to enhance the
likelihood of surgical removal of the tumor. As we continue this project, we
hope to learn which chemotherapy regimens produce the best results, and do so
safely while maintaining or improving patients' quality of life.'

Study Highlights

  * Pre-operative therapy with Gemzar plus platinum or non-platinum agents was
    highly tolerable, allowing 77 percent of patients to proceed to surgical
    removal of the tumor; of these patients, 90 percent have had complete
    removal of their lung cancer. Treatment with Gemzar-based therapy also
    demonstrated a one-year survival rate of 74 percent in clinical study.
   
  * Pulmonary function testing (assessment of how well the lungs are working)
    and dyspnea scores (assessment of breathing difficulties) obtained pre-and
    post-chemotherapy to assess drug-induced injury to the lungs and effect on
    the ability to undergo surgery confirmed the safety of these regimens. Of
    the 62 patients evaluated, only two were unable to undergo surgery because
    of reduced lung function, and no patients experienced severe respiratory
    problems.
   
  * At six months after surgery, 78 percent of patients rated their quality of
    life as improved or stable.
   
  * Seven patients reported worsening of quality of life due to undergoing more
    than one operation and/or advancing to Stage III lung cancer. The decreased
    quality of life did not seem to be a result of the chemotherapy regimen.
   
  * The most common side effects were blood-related:
   
  * 
      + Twenty-four patients (30 percent) experienced Grade 3/4 leukopenia (an
        abnormal decrease in the number of white blood cells); and 8 patients
        (10 percent) experienced Grade 3/4 thrombocytopenia (a decrease in the
        number of platelets in the blood, resulting in the potential for
        increased bleeding and decreased ability for clotting).
       
According to the World Health Organization, approximately 1.2 million people
globally will be diagnosed with lung cancer this year. It is the most lethal of
all cancers. About 80 percent of all lung cancer diagnoses are of the non-small
cell variety. As with any cancer, early detection and treatment of lung cancer
provides the best hope for managing the disease effectively.

'Gemzar has a strong heritage in the treatment of advanced non-small cell lung
cancer,' said Coleman Obasaju, MD, U.S. oncology medical director at Lilly.
'Gemzar's ability to demonstrate efficacy with a wide array of chemotherapeutic
regimens makes it a cornerstone of lung cancer therapy.'

GINEST Methods

Eighty-two patients with clinical Stage I (24 percent) and Stage II (76
percent) NSCLC were randomized and treated with chemotherapy prior to surgery. 
In the first trial, 54 patients were treated with either Gemzar 1000 mg plus
carboplatin, or Gemzar 1000 mg plus paclitaxel 200 mg. In the second trial, 28
patients received the same regimen of Gemzar/carboplatin, or Gemzar 1000 mg
plus cisplatin 75 mg. Each combination was given for three cycles every 21
days. In the quality of life evaluation, the analysis compares
patient-determined quality of life ratings from baseline to 6 months after
surgery (total 9-month evaluation period). This ongoing portion of the study
includes 33 patients (48 percent male, 52 percent female) at an average age of
63, 94 percent of whom underwent surgery. Patients completed the Lung Cancer
Symptom Scale (LCSS) (an instrument used to assess health-related quality of
life in patients with lung cancer) at baseline and every three months after
surgery.

Gemzar

Gemzar is one of the most widely studied treatments in the history of
chemotherapy agents, and has been approved for use in more than 90 countries
worldwide. It is the worldwide standard for care of pancreatic cancer and in
many parts of the world for non-small cell lung, bladder and breast cancers.
Gemzar is approved in more than 60 countries as a single agent for the
treatment of locally advanced or metastatic pancreatic cancer. It is also
approved, in combination with Taxol® (paclitaxel), in more than 30 countries
for the treatment of metastatic breast cancer. In most European countries,
Gemzar is approved as a single agent or in combination with cisplatin for the
treatment of advanced non-small cell lung cancer. Gemzar, in combination with
carboplatin, is approved in several European markets for the treatment of
recurrent epithelial ovarian cancer. Most recently, Gemzar was approved in
Mexico for cervical cancer, making it the first approval for this disease.
Gemzar is a nucleoside analogue that interferes with the process of DNA
production; thereby preventing cancer cells from replicating and thus slows or
stops tumor growth.

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, Indiana, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs. Additional
information about Lilly is available at www.lilly.com.

P-LLY

This press release contains forward-looking statements about Gemzar in
combination with Taxotere and reflects Lilly's current beliefs.  However, as
with any pharmaceutical product under development, there are substantial risks
and uncertainties in the process of development and commercialization.  There
is no guarantee that the product will receive additional regulatory approvals
and there is also no guarantee that the product will continue to be
commercially successful.  For further discussion of these and other risks and
uncertainties, see Lilly's filing with the United States Securities and
Exchange Commission.  Lilly undertakes no duty to update forward-looking
statements.

                                     # # #                                     



Eli Lilly and Company

Lilly Corporate Center

Indianapolis, Indiana 46285

U.S.A.

www.lilly.com







                                     - 4 -                                     

Evaluating the Impact of Neoadjuvant Chemotherapy and Surgery on Quality of
Life (QL) in Patients with Early Stage NSCLC: A Prospective Analysis as part of
the GINEST Project; RJ Gralla, MJ Edelman, FC Detterbeck, TM Jahan, D Loesch, S
Limentani, R Govindan, CK Obasaju, MA Socinski (Abstract # 8092)

Neoadjuvant Chemotherapy with Gemcitabine-containing Regimens in Patients with
Early Stage Non-small Cell Lung Cancer (NSCLC): Initial Results of the GINEST
Project; F. Detterbeck, MA Socinski, RJ Gralla, MJ Edelman, TM Jahan, D Loesch,
S Limentani, R Govindan, LP Bloss, CK Obasaju (Abstract # 7215)

Neoadjuvant chemotherapy with gemcitabine -containing regimens in stage I-II
Non-Small Cell Lung Cancer (NSCLC): Initial Results of pre-operative pulmonary
function testing (PFTs) in the GINEST Project;

MP Rivera, FC Detterbeck, MA Socinski, D Moore, MJ Edelman, TM Jahan, R Ansari,
J Luketich, CK Obasaju, RJ Gralla (Abstract # 7227)

F. Detterbeck (Abstract # 7215)

MP Rivera (Abstract # 7227)

RJ Gralla (Abstract # 8092)

Ibid.

F. Detterbeck (Abstract # 7215)

'Global cancer rates could increase by 50% to 15 million by 2020.' World Health
Organization 3 April 2003; Accessed 26 April 2005 http://www.who.int/
mediacentre/news/releases/2003/pr27/en/

Gemzar® (gemcitabine HCl, Lilly)

Taxol® (paclitaxel, Bristol-Myers Squibb)




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