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Lilly Reassumes Sole Worldwide Development And Commercialization Rights For Novel Basal Insulin Analog

INDIANAPOLIS and INGELHEIM, Germany, Jan. 7, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim International GmbH announced today they will adjust the scope of their diabetes alliance with respect to LY2605541*, Lilly's novel basal insulin analog, with Lilly reassuming sole worldwide development and commercialization rights to LY2605541. 

Lilly and Boehringer Ingelheim formed their diabetes alliance in January 2011, centering on four pipeline compounds representing several of the largest and most promising product classes. It is one of the largest alliances among two pharmaceuticals companies ever in a single therapeutic area and aims to provide a broad portfolio of treatment options for patients with diabetes and their healthcare professionals.

While Lilly and Boehringer Ingelheim will continue to jointly develop and commercialize the other assets in the alliance, Boehringer Ingelheim elected to terminate the collaboration with Lilly with respect to LY2605541 given independent strategic portfolio considerations.

"There is an excellent spirit of collaboration in our alliance with Lilly, and we are committed to the continued success in our partnership to develop and commercialize the other molecules within the alliance, including Trajenta® (linagliptin), empagliflozin and LY2963016, new insulin glargine product," said Dr. Ulrich Drees, Corporate Senior Vice President, International Project Management at Boehringer Ingelheim.

Lilly also announced plans for the 2013 and 2014 initiation of the remainder of the pre-planned clinical trials for LY2605541. In addition to supporting regulatory submissions, these studies will be conducted to evaluate safety, efficacy and differentiation of this novel basal insulin analog. These studies are in addition to the five ongoing IMAGINE clinical trials.

"We're encouraged by the pre-clinical, Phase I and II data we've seen for our novel basal insulin," said Gwen Krivi, Ph.D, vice president, Diabetes Product Development, Lilly Diabetes.  "We look forward to sharing the Phase III data results of our novel basal insulin therapy with the medical community as early as 2014."

"Boehringer Ingelheim is an important partner in our strategy to provide a broad portfolio of diabetes medicines, and our diabetes alliance remains strong," said Enrique Conterno, president of Lilly Diabetes. "There is no group of patients with whom Lilly has a deeper history than those impacted by diabetes. If approved, this basal insulin analog will be an important addition to the Lilly portfolio as we work to provide a broad portfolio of diabetes medicines to our customers."

If the Phase III trials for LY2605541 are successful, Lilly could submit its novel basal insulin analog to regulatory authorities as early as 2014, as previously communicated.

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