Study Published in The Lancet Showed Significant Survival Benefit for Patients Facing...

Study Published in The Lancet Showed Significant Survival Benefit for Patients
Facing Deadly Form of Lung Cancer
Study Evaluated Lilly's ALIMTA(R) (pemetrexed for injection) versus Placebo as
Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients

INDIANAPOLIS, Sept. 21 /PRNewswire-FirstCall/ -- Data published today in The
Lancet showed a survival benefit in nonsquamous patients with advanced
non-small cell lung cancer (NSCLC) who received maintenance therapy with
ALIMTA(R) (pemetrexed for injection) plus best supportive care as compared to
placebo plus best supportive care.

This Phase III clinical trial supported previous studies looking at the use of
histology to tailor treatment with ALIMTA for patients with advanced
nonsquamous NSCLC. Advanced nonsquamous NSCLC patients on the ALIMTA plus
best supportive care arm achieved more than five months increased median
overall survival compared to nonsquamous NSCLC patients who received placebo
plus best supportive care following initial chemotherapy.

The publication of The Lancet manuscript follows the July 2009 U.S. Food and
Drug Administration (FDA) approval of ALIMTA as maintenance therapy for
patients with locally advanced or metastatic nonsquamous NSCLC, whose disease
has not progressed after four cycles of platinum-based first-line
chemotherapy. ALIMTA is not indicated for treatment in patients with squamous
cell NSCLC. The European Commission also granted a similar approval in July
2009.

NSCLC is defined as a group of histologies, that is, tumor types
differentiated by cellular structure. Nonsquamous histology includes
adenocarcinoma and large cell carcinoma - which account for about 70 percent
of all NSCLC diagnoses(1) - as well as histologies classified as "other."
About 30 percent of all NSCLC cases are squamous.(2)

Maintenance therapy is a relatively new concept in NSCLC treatment, according
to study lead author Chandra P. Belani, M.D., Miriam Beckner distinguished
professor of medicine and deputy director of Penn State Cancer Institute at
Penn State Milton S. Hershey Medical Center in Hershey, Pa.

"Previously, we would treat patients with advanced non-small cell lung cancer
with four cycles of a platinum-based therapy, and then wait for a recurrence
before treating again," said Dr. Belani. "The results of this study are
provocative and introduce the concept of maintenance therapy for patients with
non-small cell lung cancer."

"What makes these findings more compelling is a survival advantage exceeding
five months with ALIMTA for patients with nonsquamous cell histologies. The
degree of patient benefit is substantial," added Dr. Belani.

"This study is very encouraging for our fight against this deadly disease,"
added Richard Gaynor, M.D., Lilly's vice president of cancer research and
global oncology platform leader. "First, it makes a case for maintenance
therapy in advanced, nonsquamous NSCLC. Secondly, it showcases the importance
of histology in tailoring a treatment to the nonsquamous NSCLC patient."

The Lancet manuscript of ALIMTA as a maintenance therapy for advanced
nonsquamous NSCLC summarized findings from a global, multicenter, double-blind
Phase III trial that was presented by Dr. Belani in an oral presentation at
the American Society of Clinical Oncology (ASCO) annual meeting in Orlando,
Fla. on May 31, 2009.(3)

The trial compared the efficacy of ALIMTA plus best supportive care versus
placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC
whose disease had not progressed after four cycles of platinum-based induction
chemotherapy.

According to the results, patients treated with ALIMTA demonstrated
statistically superior overall survival compared to those treated with placebo
(13.4 months vs. 10.6 months). But when breaking down the data by histology,
researchers found nonsquamous patients on the ALIMTA arm achieved 15.5 months
median overall survival compared to 10.3 months for nonsquamous patients on
the placebo arm. Patients with squamous cell carcinoma who were treated with
ALIMTA did not see an improvement in overall survival as compared to placebo
(9.9 vs. 10.8 months, respectively).

Patients in the trial were treated with ALIMTA (500 mg/m2 on day one of each
21-day cycle) or placebo. All patients were supplemented with vitamin B12,
folic acid and dexamethasone.

Drug-related grade 3/4 toxicities were higher for those treated with ALIMTA
vs. placebo (16% vs. 4%); specifically, anemia (3% vs. 1%), neutropenia (3%
vs. 0%), leucopenia (2% vs. 1%), fatigue (5% vs. 1%), anorexia (2% vs. 0%),
mucositis/stomatitis (1% vs. 0%), diarrhea (1% vs. 0%), infection (2% vs. 0%),
and neuropathy-sensory (1% vs. 0%). Increases in adverse reactions (all
grades) were observed with longer exposure. Grade 3/4 toxicities did not
increase significantly in patients who received greater than or equal to six
cycles and greater than or equal to ten cycles of ALIMTA.

ALIMTA is also approved for: first-line treatment of advanced, nonsquamous
NSCLC in combination with a platinum-based chemotherapy; as a single agent in
the second-line setting for advanced, nonsquamous NSCLC patients with
recurrent disease; and in combination with cisplatin as a treatment for
patients with malignant pleural mesothelioma, whose disease is unresectable or
who are otherwise not candidates for curative surgery.

For full prescribing and safety information about ALIMTA, visit
www.ALIMTA.com.

Notes to Editor
About Non-Small Cell Lung Cancer (NSCLC)
Globally, lung cancer impacts more than 3 million people and is one of the
most common cancers worldwide, accounting for 1.2 million new cases
annually.(4) About 85 - 90 percent of all lung cancers are NSCLC.(5)(6)

About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been dedicated to delivering
innovative solutions that improve the care of people living with cancer.
Because no two cancer patients are alike, Lilly Oncology is committed to
developing novel treatment approaches. Our quest is to develop a broad
portfolio of tailored therapies that accelerate the pace and progress of
cancer care. To learn more about Lilly's commitment to cancer, please visit
www.LillyOncology.com.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of 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.

P-LLY

ALIMTA(R) (pemetrexed for injection), Lilly

Important Safety Information for ALIMTA
ALIMTA is approved by the FDA in combination with cisplatin (another
chemotherapy drug) for the initial treatment of advanced nonsquamous non-small
cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated
for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced
non-squamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, to
maintain the effect of initial treatment with chemotherapy and whose disease
has not worsened. ALIMTA is not indicated for patients who have a different
type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment
of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a
specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for
patients who have a different type of NSCLC called squamous cell.

ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a
cancer that affects the inside lining of the chest cavity. ALIMTA is given
with cisplatin, another anticancer medicine (chemotherapy), when surgery is
not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to
ALIMTA, tell your doctor because you should not receive it. If you think you
are pregnant, are planning to become pregnant, or are nursing, please tell
your healthcare team. ALIMTA may harm your unborn or nursing baby. Your
physician may advise you to use effective contraception (birth control) to
prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose
of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is
a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress
bone marrow function. It is very important to take folic acid and vitamin B12
prior to and during your treatment with ALIMTA to lower your chances of
harmful side effects.

Your healthcare professional will prescribe a medicine called a
corticosteroid, which lowers your chances of getting skin reactions with
ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs
(nonsteroidal anti-inflammatory drugs used to treat pain or swelling).

Tell your doctor if you are taking other medicines, including prescription and
non-prescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with
cisplatin, another chemotherapy drug, are low blood cell counts (red blood
cells, white blood cells, and platelets); tiredness; stomach upset, including
nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite;
rash; and constipation.

Call your healthcare professional right away if you have a fever, chills,
diarrhea, or mouth sores. These symptoms could mean you have an infection.
These are not all of the side effects of ALIMTA. If you have any side effect
that bothers you or that does not go away, be sure to talk with your
healthcare professional.

You will have regular blood tests before and during your treatment with
ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment
based on the results of your blood test and on your general condition.

For more information about all of the side effects of ALIMTA, please talk with
your healthcare team, see the Patient Prescribing Information and full
Prescribing Information, visit www.ALIMTA.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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. There is no guarantee that the product will continue 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

(1) The Wellness Community, "Understanding Lung Cancer," Available at:
http://www.thewellnesscommunity.org/mm/Learn-About/cancertype/lungcancer/Undertstanding-Lung-Cancer.aspx.
Accessed July 24, 2009.
(2) The Wellness Community, "Understanding Lung Cancer," Available at:
http://www.thewellnesscommunity.org/mm/Learn-About/cancertype/lungcancer/Undertstanding-Lung-Cancer.aspx.
Accessed July 24, 2009.
(3) C. P. Belani, T. Brodowicz, et al. Maintenance pemetrexed (Pem) plus best
supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III
study in advanced non-small cell lung cancer (NSCLC). Abstract #CRA8000. 2009
American Society of Clinical Oncology (ASCO) Annual Meeting. J Clin Oncol
27:18s, 2009 (suppl; abstr CRA8000).
(4) World Health Organization: Global cancer rates could increase by 50% to 15
million by 2020, Fact sheet. Available at:
http://www.who.int/mediacentre/news/releases/2003/pr27/en/. Accessed July 10,
2009.
(5) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October
15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri.
Accessed February 21, 2008.
(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October
15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri.
Accessed February 21, 2008.

SOURCE Eli Lilly and Company

Amy Sousa, Lilly, +1-317-276-8478 (office), +1-317-997-1481 (mobile),
sousa_amy_e@lilly.com; or Neil Hochman, TogoRun, +1-212-453-2067 (office),
+1-516-784-9089 (mobile), n.hochman@togorun.net