BOEHRINGER SAYS GLARGINE ACCEPTED FOR REVIEW BY EMA (ENG)

     (The following press release from Boehringer Ingelheim was received by 
e-mail. It was not confirmed by the sender.) 
Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission 
for new insulin glargine biosimilar product
European Medicines Agency accepted companies' marketing authorisation 
application
Indianapolis, U.S., and Ingelheim, Germany, July 08, 2013 – Eli Lilly and 
Company (NYSE: LLY) and Boehringer Ingelheim today announced that the 
companies' marketing authorisation application (MAA) for LY2963016, an 
investigational basal (long-acting) insulin for the treatment of type 1 and 
type 2 diabetes, has been accepted for review by the European Medicines Agency 
(EMA). LY2963016 is a new insulin glargine product and has been filed through 
the EMA's biosimilar pathway. 
Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive 
clinical development program in order to meet the highest standards of safety, 
efficacy and quality. In addition to pharmacokinetic and pharmacodynamic 
studies, Phase III studies in patients with type 1 and type 2 diabetes have 
been conducted and results submitted, using currently marketed insulin glargine 
as the active comparator. 
"Long-acting insulin is a mainstay treatment for many people with diabetes, and 
we anticipate that insulin glargine will continue to be widely used for many 
years to come," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product 
development. "We are pleased that the EMA’s acceptance of our application 
brings us closer to offering a new insulin glargine product to clinicians and 
their patients, coupled with the expertise they expect from Lilly and 
Boehringer Ingelheim."
 
 
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