LEL Lilly(Eli)

 
TIDMLEL 
 
Date: July 22, 2011 
 
For Release: Immediately 
 
Refer to: Sonja Popp-Stahly, +1 (317) 655-2993, spopp-stahly@lilly.com 
 
              European CHMP Adopts Negative Opinion on Duloxetine 
          for the Treatment of Moderately Severe Chronic Somatic Pain 
 
INDIANAPOLIS - The Committee for Medicinal Products for Human Use (CHMP) of the 
European Medicines Agency (EMA) has adopted a negative opinion recommending 
against approval for Eli Lilly and Company's (NYSE: LLY) duloxetine 
hydrochloride application for the treatment of moderately severe chronic 
somatic pain (as established in chronic low back pain and osteoarthritis). 
 
"Although we are disappointed by the CHMP's decision, we remain confident in 
the clinical profile of duloxetine," said Michael Robinson, M.D., senior 
medical director at Lilly. 
 
The CHMP issued its opinion after reviewing safety and efficacy data from 839 
patients exposed to duloxetine (representing 131 patient-years of exposure) 
from two clinical studies of chronic pain due to osteoarthritis, three clinical 
studies of chronic low back pain (CLBP) and a long-term extension from one of 
the CLBP studies. Additionally, safety data from the approved indication for 
diabetic peripheral neuropathic pain, as well as from other studied 
indications, were included in this submission. 
 
"We will continue to work to address the CHMP's questions and pursue a way 
forward," said Robert Baker, M.D., global development leader for psychiatry and 
pain disorders at Lilly. 
 
Chronic pain of moderate to severe intensity occurs in 19 percent of the adult 
European population (more than 80 million people), with more than one third of 
the European population experiencing chronic pain at some point in their 
lives.,,, In particular, chronic low back pain and osteoarthritis are two of 
the most prevalent types of chronic pain., 
 
In Europe, duloxetine has been approved for the treatment of diabetic 
peripheral neuropathic pain (DPNP), major depressive disorder (MDD), 
generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). 
 
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. 
 
 
This press releasecontains forward-looking statements about the potential of 
Cymbalta for the treatmentof chronic somaticpain, 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. 
 
                                     # # # 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
 
 
 
 
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European Commission. Eurostat. Total population. Available at: http:// 
epp.eurostat.ec.europa.eu/tgm/table.do?tab=table&language=en&pcode=tps00001& 
tableSelection=1&footnotes=yes&labeling=labels&plugin=1. Accessed on 1 July 
2011 
 
European Commission. Eurostat. Population age structure by major age groups 
(%). Available at: http://epp.eurostat.ec.europa.eu/statistics_explained/ 
index.php?title=File:Population_age_structure_by_major_age_groups_(%25).png& 
filetimestamp=20110210124252 Accessed on 1 July 2011. 
 
Breivik, J. et al. Survey of chronic pain in Europe: prevalence, impact on 
daily life, and treatment. European Journal of Pain. 2006;10:287-333. 
 
International Association for the Study of Pain, European Federation of IASP 
Chapters. Unrelieved pain is a major global healthcare problem (IASP EFIC 
Factsheet 4A). 2004. Available at: http://www.iasp-pain.org/AM/Template.cfm? 
Section=Home&Template=/ CM/ContentDisplay.cfm&ContentID=2908. Accessed on 23 
June 2011. 
 
Dionne et al. Does back pain prevalence really decrease with increasing age? A 
systematic review. Age and Ageing. 2006;35(3):229-334. 
 
Lawrence RC, et al. Estimates of the Prevalence of Arthritis and Other 
Rheumatic Conditions in the United States. Arthritis & Rheumatism. 2008.58(1): 
26-35. 
 
 
 
 
END 
 

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