Eli Lilly and Company logo. (PRNewsFoto) INDIANAPOLIS, IN USA

   Lilly Oncology to present more than a dozen studies designed to better
                          predict patient outcomes

    LOS ANGELES, April 15 /PRNewswire-FirstCall/ -- Delivering on its
commitment to relentless progress in cancer care; Lilly Oncology will
present 17 studies at the 2007 American Association for Cancer Research
(AACR) Annual Meeting in Los Angeles from April 14-18, 2007. Many of the
studies -- which investigate ALIMTA(R) (pemetrexed for injection);
GEMZAR(R) (gemcitabine HCl for injection), enzastaurin and other products
in Lilly's pipeline are aimed at utilizing pharmacogenomic information such
as biomarkers to enhance treatment and improve patient outcomes. Biomarkers
are genetic indicators that help predict how patients will respond to
certain therapies.
    "Lilly Oncology shares the commitment of the American Association for
Cancer Research to use innovative research as a true catalyst in the fight
against cancer," said Richard Gaynor, M.D., vice president, cancer research
and global oncology platform leader at Lilly. "The goal of the Lilly
Oncology research program is to investigate our current medications, and
those in our pipeline, to find the right medication, at the right dose at
the right time for patients."
    Lilly Oncology's newest product, ALIMTA, is the foundation of eight
studies being presented at AACR and is currently being investigated in
several global Phase III trials -- JMDB in 1st-line metastatic non-small
cell lung cancer (NSCLC), JMEN as a maintenance therapy in metastatic
NSCLC, in the GALES trial for the treatment of small cell lung cancer, and
the global Phase III SPINNAKER trial for the treatment of head and neck
cancer. ALIMTA is also being studied in locally advanced and adjuvant
NSCLC, ovarian and gastric cancers. ALIMTA is a standard-of-care in the
treatment of malignant pleural mesothelioma (MPM) and second-line non-small
cell lung cancer.
    GEMZAR, which celebrated its 10th anniversary as a marketed product for
patients in the United States last year, forms the basis of two trials
being presented at AACR. GEMZAR is approved in the treatment of pancreatic,
NSCLC, breast and ovarian cancers in the United States. In addition,
outside of the US, several countries have the additional indication in
metastatic bladder, cervical and biliary tract cancers.
    Enzastaurin is an investigational oral, serine threonine kinase
inhibitor which selectively targets the PKC-(beta) and PI3/AKT signaling
pathways and is the subject of seven studies being presented at AACR.
Enzastaurin is currently being investigated in a global Phase III PRELUDE
trial for the treatment of diffuse large B-cell lymphoma, the most common
type of non-Hodgkin's lymphoma. Enzastaurin is also being evaluated in
Phase II studies across several tumor types including: breast, colon,
non-small cell lung, pancreas, ovarian and prostate cancers.
    In partnership with the AACR, Lilly Oncology will also recognize
innovative and collaborative research with the sponsorship and presentation
of the first-ever Team Science Award and the annual G.H.A. Clowes Memorial
Award.
    The most common adverse events (grades 3/4) with ALIMTA in combination
with cisplatin for the treatment of patients with MPM were neutropenia
(24%); leukopenia (16%); anemia (6%); thrombocytopenia (5%); infection
without neutropenia (2%); fatigue (17%); thrombosis/embolism (6%); nausea
(12%); vomiting (11%); dyspnea (11%); and chest pain (9%). The most common
clinically relevant adverse events (all grades) were fatigue (80%);
thrombosis/embolism (7%); nausea (84%); vomiting (58%); constipation (44%);
anorexia (35%); stomatitis/pharyngitis (28%); diarrhea (26%); dyspnea
(66%); chest pain (40%); and rash (22%).
    The most common adverse events (grades 3/4) with ALIMTA for the
treatment of patients with NSCLC were anemia (8%); leukopenia (5%);
neutropenia (5%); thrombocytopenia (2%); infection without neutropenia
(6%); fatigue (16%); thrombosis/embolism (3%); cardiac ischemia (3%);
anorexia (5%); dyspnea (18%); and chest pain (7%). The most common
clinically relevant adverse events (all grades) were fatigue (87%);
anorexia (62%); nausea (39%); constipation (30%); vomiting (25%); diarrhea
(21%); stomatitis/pharyngitis (20%); dyspnea (72%); chest pain (38%);
neuropathy/sensory (29%); infection without neutropenia (23%); and rash
(17%).
    The most severe adverse events (grades 3/4) with GEMZAR plus paclitaxel
for the treatment of patients with MBC were neutropenia (48%); alopecia
(18%); leukopenia (11%); anemia (7%); fatigue (7%); thrombocytopenia (6%);
ALT elevation (6%); and neuropathy-sensory (6%). The most common adverse
events (all grades) were nausea (50%); fatigue (40%); myalgia (33%); and
vomiting (29%).
    The most severe adverse events (grades 3/4) with GEMZAR for the
first-line treatment of patients with pancreatic cancer were neutropenia
(24%-26%); alkaline phosphatase elevation (16%-20%); AST elevation
(12%-17%); nausea/vomiting (12%-13%); ALT elevation (10%-11%); anemia
(10%); leukopenia (9%-10%); thrombocytopenia (8%-10%); bilirubin elevation
(4%-8%); and pain (2%-7%). The most common adverse events (all grades) were
AST (72%-78%); alkaline phosphatase (71%-77%); anemia (65%-73%); ALT (72%);
leukopenia (64%- 71%); nausea and vomiting (64%-71%); neutropenia
(61%-62%); thrombocytopenia (36%-47%); pain (10%-42%); fever (30%-38%);
proteinuria (10%-32%); constipation (10%-31%); diarrhea (24%-30%); rash
(24%-28%); and bilirubin (16%-26%).
    The most severe adverse events (grades 3/4) with GEMZAR plus cisplatin
for the first-line treatment of patients with NSCLC were neutropenia
(57%-64%); thrombocytopenia (50%-55%); leukopenia (29%-46%); anemia
(22%-25%); nausea (27%); vomiting (23%); nausea/vomiting (39%); neuromotor
(12%); hypomagnesemia (7%); neurohearing (6%); creatinine elevation (5%);
alopecia (1%-13%); and dyspnea (1%-7%). The most common adverse events (all
grades) were paresthesias (38%); hyperglycemia (30%); infection (18%-28%);
and constipation (17%-28%).
    The most severe adverse events (grades 3/4) with GEMZAR plus
carboplatin for the treatment of patients with advanced ovarian cancer were
neutropenia (71%), thrombocytopenia (35%), leukopenia (53%), anemia (28%),
nausea (6%), vomiting (6%), and constipation (7%). The most common adverse
events (all grades) were RBC transfusion (38%), alopecia (49%),
neuropathy/sensory (29%), nausea (69%), fatigue (40%), vomiting (46%),
diarrhea (25%), and constipation (42%).
    See complete Warnings, Precautions, Adverse Reactions, Dosage and
Administration sections in the accompanying full Prescribing Information
for safety and dosing guidelines.
    Enzastaurin administration is associated with fatigue, diarrhea,
nausea, decreased platelets, cough, vomiting, transaminase elevation,
dyspnea, peripheral edema, and dizziness. Further testing in Phase III
versus a placebo will provide a more complete look at the side effect
profile for enzastaurin.
    O-LLY
    (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

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