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Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma



 Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in
                        Diffuse Large B-Cell Lymphoma

PR Newswire

INDIANAPOLIS, May 10, 2013

INDIANAPOLIS, May 10, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
announced today Phase III clinical trial results from enzastaurin's PRELUDE
study, which explored the molecule as a monotherapy in the prevention of
relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study
failed to show a statistically significant increase compared to placebo in
disease-free survival in patients at high risk of relapse following
rituximab-based chemotherapy. There were no new safety findings, and the
safety data were consistent with previously disclosed studies.

"We are disappointed in the results that we're announcing today," said Richard
Gaynor, M.D., vice president, product development and medical affairs for
Lilly Oncology.  "However, our oncology pipeline is still one of the most
robust across the industry containing more than 20 molecules, including two
Phase III molecules in five different tumor types."

Lilly plans to present data from this study at an upcoming scientific meeting.

Lilly will stop development of enzastaurin, which is expected to result in a
second-quarter charge to R&D expense of approximately $30 million. The
company's previously-issued financial guidance for 2013 remains unchanged.

About the Study
Patients enrolled in PRELUDE had histologically confirmed DLBCL with an
International Prognostic Index (IPI) score of three to five at diagnosis. The
IPI is a simple, clinical tool that is used to predict survival outcomes for
patients with DLBCL. Patients enrolled also achieved a complete response or
complete response-unconfirmed to cyclophosphamide, doxorubicin, vincristine,
and prednisone, plus rituximab (R-CHOP) therapy. Patients were randomized in a
2:1 fashion to receive enzastaurin or placebo.

Treatment continued until patients developed progression of disease,
unacceptable adverse events, or completed three years of therapy.

About Enzastaurin
Enzastaurin (LY317615 HCl) is an investigational oral small molecule,
serine/threonine kinase inhibitor of the PKC beta and AKT pathways. [1],[2]

About Diffuse Large B-cell Lymphoma
Non-Hodgkin's lymphomas (NHL) are cancers of the body's lymphatic system
consisting of  clonal proliferation of immune cells. Non-Hodgkin's lymphomas
constitute a heterogeneous group of malignant tumors with a wide variety of
histologic appearances, clinical behaviors, and prognoses. (Armitage 1993).
DLBCL is a sub-type of NHL.

About Lilly's Pipeline   
Lilly currently has a number of unique potential medicines in its Phase III
clinical development pipeline, representing a variety of therapeutic areas
including diabetes, cancer, neuroscience, autoimmunity and cardiovascular. To
learn more about the molecules in Lilly's clinical development pipeline,
please visit Lilly's interactive pipeline website available
at www.lilly.com/pipeline.

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.  Additional information about Lilly is available at
www.lilly.com.

P-LLY

This press release contains forward-looking statements about the potential of
enzastaurin as a treatment of DLBCL 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 future studies will be positive or that enzastaurin will
receive regulatory approvals 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.

Refer to:
Keri S. McGrath, Lilly Oncology
317-277-3768 (office)
317-370-8394 (mobile)
Email: mcgrath_happe_keri_s@lilly.com

[1] Graff JR, et al. Cancer Res. 2005; 65:7462-7469
[2] Brautigam K, et al. Transl Oncol. 2009; 2; 164-173

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

 

SOURCE Eli Lilly and Company

Website: http://www.lilly.com
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