Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)

Indianapolis (ots/PRNewswire) -

- Oral Agent Designed to Address High Incidence of Relapse in
DLBCL Population

Eli Lilly and Company announced today that the European Medicines
Agency (EMEA) has granted enzastaurin, an investigational,
multi-targeted, oral, cancer agent, orphan drug designation for the
treatment of diffuse large B-cell lymphoma (DLBCL). Although rare,
DLBCL is the most common sub-type of non-Hodgkin's lymphoma (NHL) of
which approximately 50% of high-risk patients (high-risk is defined
as having an International Prognostic Index score of 3-5) relapse
within three years after receiving first line therapy. (1) An
International Prognostic Index score (IPI) is a criteria determined
by a patient's oncologist.

Enrollment into a Phase III clinical trial studying enzastaurin is
currently underway. The PRELUDE (Preventing Relapse in Lymphoma Using
Daily Enzastaurin) trial is a randomized, placebo controlled study in
DLBCL patients at high risk for relapse who have achieved remission
following first-line therapy. Specifically, enzastaurin is being
investigated as a maintenance therapy to prevent disease relapse. The
study will compare the efficacy, safety and tolerability of
enzastaurin, taken orally for up to three years, versus placebo. The
study is expected to enroll 459 patients across 100 sites worldwide.
The primary endpoint of the study will be overall disease-free
survival. More details on the study design, inclusion criteria and
how to enroll are available at www.lillytrials.com or by visiting
www.clinicaltrials.gov.

"In recent years, there has been progress in improving first-line
therapies that help more patients achieve remission. However, our
objective with enzastaurin is to develop an agent that may fill this
important therapeutic need -- the ability to keep DLBCL patients in
remission," said Richard Gaynor, M.D., vice president, cancer
research and global oncology platform leader for Eli Lilly and
Company.

Enzastaurin

Enzastaurin is an oral, serine threonine kinase inhibitor which
selectively targets the PKCBeta and PI3/AKTsignaling pathways. By
blocking these key pathways frequently over-expressed in a wide
variety of cancers, enzastaurin suppresses tumor cell proliferation,
induces tumor cell death and inhibits tumor-induced angiogenesis.
Treatment has been well tolerated with minimal drug-related toxicity.
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 us with a more complete look at the
side effect profile for enzastaurin. In addition to DLBCL,
enzastaurin is also being studied in other tumor types including
breast, colon, lung, ovarian and prostate cancers.

Non-Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma

Non-Hodgkin's lymphoma is the most common cancer of the lymphatic
system, the body's defense mechanism against infection and disease.
Once considered rare, non-Hodgkin's lymphoma rates have increased 83
percent in the past 25 years. NHL is now considered the fifth most
common of all cancers, with more than 56,000 new diagnoses made in
the United States each year and 46,000 new cases each year in the
European Union.

Diffuse large B-cell lymphoma (DLBCL) describes the appearance of
the malignant B-cells in the lymphoma and it is the most frequently
occurring histologic subtype in adults, constituting approximately
31% of all new diagnoses (Armitage and Weisenburger 1998). The vast
majority of relapses occur in the first 2 years after therapy
(Cabanillas et al. 1992). Life expectancy of untreated patients with
DLBCL is very short.

Orphan Medical Product Designation in the European Union

Orphan medicinal products are for diagnosing, preventing or
treating life-threatening or very serious conditions that are rare
and affect not more than 5 in 10,000 persons in the European Union.

About Lilly Oncology, a division of Eli Lilly and Company

For more than four decades, Lilly Oncology has been collaborating
with cancer researchers to deliver innovative treatment choices and
valuable programs to patients and physicians worldwide. Inspired by
the courageous patients living with cancer, Lilly Oncology is
providing treatments that are considered global standards of care and
developing a broad portfolio of novel targeted therapies to
accelerate the pace and progress of cancer care.

About 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, 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 the investigational compound enzastaurin (LY317615) 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 regulatory review.
There is no guarantee that the product will receive regulatory
approvals, or that the regulatory approval will be for the
indication(s) anticipated by the company. There is also no guarantee
that the product will 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) Shen, Laurie H and col. 2007. The Revised International
Prognostic Index (R-IPI) is a better predictor of outcome than the
standard IP for patients with diffuse large B cell Lymphoma treated
with RCHOP. Blood 109 (N5):1857, 1861.

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ots Originaltext: Eli Lilly and Company
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Contact:
Christine Van Marter of Eli Lilly and Company, +1-317-651-1473, or
vanmarterch@lilly.com. Photo:
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