Lilly Suspends Phase III Trial in Metastatic Melanoma

INDIANAPOLIS, Dec. 13, 2010 /PRNewswire/ — Eli Lilly and Company announced

today that it has suspended its global Phase III study evaluating tasisulam, an
investigational, small-molecule anti-cancer compound, as a second-line treatment
for those with unresectable or metastatic melanoma.

Lilly, in consultation with an independent data monitoring committee,
recommended a “full clinical hold,” because of safety concerns. A full clinical
hold ensures that no new or existing patients in the trial receive additional
doses of the compound, allowing researchers the time to fully analyze existing
data.

Lilly notified regulatory agencies and contacted all trial investigators to
provide details on how to manage individuals enrolled in the trial.

“We are thoroughly reviewing the clinical trial data to understand what
modifications to the study protocol or dosing would be needed to improve patient
safety on this trial,” said Richard Gaynor, M.D., vice president, oncology
product development and medical affairs for Lilly.

Lilly continues to develop tasisulam as part of an extensive clinical
development program across a wide range of tumors, including soft tissue
sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung
cancer and acute leukemia. At this time, these trials continue without
modification because the dosing of tasisulam is different. Lilly is closely
evaluating patient safety within these trials on an ongoing basis.

“We remain committed to Lilly Oncology’s active fight against cancer, especially
for patients facing cancers where the need for new treatments is especially
great,” added Gaynor.

The Phase III trial sought to compare the efficacy, safety and tolerability of
tasisulam versus paclitaxel, as a second-line treatment for those with
metastatic melanoma. The study enrolled more than 300 patients in 18 countries.
The primary endpoint of this study is overall survival.

Tasisulam was granted orphan drug status for stage 2b-IV melanoma by the U.S.
Food and Drug Administration in late 2009.

Notes to Editor

About Melanoma

Melanoma is the deadliest form of skin cancer and is frequently attributed to
exposure to ultraviolet (UV) radiation.(1) Although U.S. incidence rates for
many cancers have been on the decline, new cases of melanoma have been
increasing for the past 30 years.(1) Recent estimates suggest that more than
68,000 people are diagnosed annually in the U.S. with melanoma.(2) Melanoma has
a pathological staging system, starting at 0 and rising to the severity of stage
IV.(2) The cancer can metastasize, or spread rapidly, moving from the skin to
the blood and lymphatic vessels, and then on to the rest of the body(1) becoming
the most deadly form of the disease.(3)

About Lilly Oncology

For more than four decades, Lilly Oncology, a division of Eli Lilly and Company,
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. 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

This press release contains forward-looking statements about the potential of
tasisulam for the treatment of metastatic melanoma 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 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.

(1) American Cancer Society, “Detailed Guide: Skin Cancer – Melanoma – What Are
the Key Statistics About Melanoma?” March 5, 2010. Available at:.

http://www.cancer.org/Cancer/SkinCancer-Melanoma/DetailedGuide/melanoma-skin-cancer-key-statistics

Accessed on April 30, 2010.

(2) American Cancer Society, “Detailed Guide: Skin Cancer – Melanoma: How Is
Melanoma Staged?” March 5, 2010. Available at:

http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_How_is_melanoma_staged_50.asp?rnav=cri.

Accessed on May 5, 2010.

(3) American Academy of Dermatology, “Malignant Melanoma” 2010. Available at:
http://www.aad.org/public/publications/pamphlets/sun_malignant.html. Accessed on
April 30, 2010.

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SOURCE Eli Lilly and Company