Study Determined Best Dose and Showed 55 Percent Response Rate With Lilly Anti-BAFF Monoclonal Antibody in Previously-Treated Multiple Myeloma Patients

INDIANAPOLIS, May 19, 2011 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY)
announced Phase I data on LY2127399, a human monoclonal antibody that
neutralizes B-cell activating factor (BAFF), for use in combination with
bortezomib in patients with previously-treated multiple myeloma. Results from
the Phase I study will be presented on Sunday, June 5 at 11:30 a.m. CDT during
the Lymphoma and Plasma Cell Disorders Oral Abstract Session (Abstract #8012) at
the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, Ill.

BAFF is a soluble protein found on the surface of immune cells. In some cases,
BAFF levels are increased in the serum of patients with multiple myeloma.
Researchers believe that BAFF stimulates myeloma cells to grow and resist the
effects of chemotherapy.

Twenty patients were enrolled in the first-stage of the trial in order to
determine the primary endpoint — the dose of LY2127399 that can be safely used
in combination with bortezomib, an approved therapy for patients with
previously-treated multiple myeloma. The analysis suggested doses of at least
100 mg of LY2127399 would be most appropriate for further study. Researchers
also assessed response rate, a secondary endpoint in this trial, and found that
11 of 20 patients achieved a partial response or better.

“This study identified the appropriate dose range and affirmed the potential of
this anti-BAFF monoclonal antibody in combination with bortezomib,” said Noopur
Raje, M.D., the study’s principal investigator and director of the Multiple
Myeloma Program at the Massachusetts General Hospital and an associate professor
at Harvard Medical School. “These findings are the first step for a potential
new treatment in fighting multiple myeloma.”

Patients were evaluated at five different dose levels of LY2127399: 1 mg (n=3),
10 mg (n=4), 30 mg (n=5), 100 mg (n=3) and 300 mg (n=5), in combination with
bortezomib at 1.3 mg/m2. Bortezomib was administered intravenously on days one,
four, eight and 11 in a 21-day treatment cycle while LY2127399 was administered
intravenously on day one in cycles one through three and on day one of every
other cycle thereafter. The median number of prior therapies for the group was
three, with 65 percent of the patients having previously received bortezomib and
80 percent received either thalidomide or lenalidomide.

LY2127399 is also in Phase III evaluation as a potential treatment for
rheumatoid arthritis and systemic lupus erythematosus.

“While this molecule began its developmental journey outside of oncology,
researchers recognized its potential for multiple myeloma,” said Richard Gaynor,
M.D., vice president of product development and medical affairs at Lilly
Oncology. “It is this kind of bench-to-bedside research that enabled us to get
one step closer to providing medicines to patients in need.”

Patients enrolled in the trial had relapsed or refractory multiple myeloma and
had been previously treated with at least one prior regimen. No dose-limiting
toxicities were observed on the trial. Grade 3/4 adverse events observed during
the study included thrombocytopenia (n=4), neutropenia (n=3), anemia (n=1),
diarrhea (n=2), neuropathy (n=2), hypercalcemia (n=1), mucositis (n=1),
gastrointestinal hemorrhage (n=1), renal failure (n=1), sepsis (n=1) and pain
(n=1). Two patients discontinued the study due to neuropathy and one
discontinued because of thrombocytopenia. One patient discontinued due to
progressive disease at cycle five and died three months later.

About Multiple Myeloma

Multiple myeloma is a cancer of plasma cells, a type of white blood cell that
creates antibodies. Multiple myeloma causes excess production of an abnormal
antibody known as a monoclonal protein. Multiple myeloma causes hypercalcemia,
anemia, low platelet counts, increases the risk of infection and weakens the
bones increasing the risk of fracture, pain, and disability. Across the U.S.
more than 20,000 new cases of multiple myeloma are reported each year, with
approximately 10,500 deaths attributed to the disease annually.(1)

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

bortezomib, Velcade®, Millenium Pharmaceuticals

This press release contains forward-looking statements about the potential of
LY2127399 and reflects Lilly’s current beliefs. However, as with any
pharmaceutical compound, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee that this
compound will be approved by the relevant regulatory authorities or 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) U.S. National Library of Medicine. Multiple Myeloma. National Center for
Biotechnology Information. http://www.cancer.gov/cancertopics/types/myeloma.
(April 25, 2011).

SOURCE Eli Lilly and Company