Eli Lilly, Boehringer Say MAA For LY2963016 Accepted For Review By EMA

(RTTNews) - Drug maker Eli Lilly and Co. (LLY) and German peer Boehringer Ingelheim announced Monday that the the European Medicines Agency (EMA) has accepted for review their marketing authorization application or MAA, for LY2963016, a new insulin glargine biosimilar product.

The two companies had entered into an alliance in January 2011 in the field of diabetes that centers on three compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies.

"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," said Gwen Krivi, vice president, Lilly Diabetes product development.

LY2963016 is an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes. It is a new insulin glargine product and has been filed through the EMA's biosimilar pathway.

The companies have conducted late stage studies in patients with type 1 and type 2 diabetes and submitted its results for the approval. The studies were conducted using currently marketed insulin glargine as the active comparator.

Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.

About 25.8 million Americans and an estimated 371 million people worldwide have type 1 and type 2 diabetes, according to the International Diabetes Federation.

LLY closed Friday's regular trading session at $50.58, down $0.01 on a volume of 2.70 million shares.