Eli Lilly has resumed sole development and commercialisation rights to a new insulin analogue formerly covered by its diabetes alliance with Boehringer Ingelheim.

The alliance, formed two years ago, centred on four pipeline compounds relevant to major aspects of diabetes treatment.

The basal insulin analogue LY2605541will now progress to clinical trials under Lilly’s sole control.

The two companies are still working together to develop and commercialise three products including Trajenta (linagliptin), a drug for type 2 diabetes.

The partnership aimed to provide a broad portfolio of drugs for people with diabetes, but Lilly has now opted to shift LY2605541to its own drug portfolio.

Lilly will continue with the planned clinical trials of LY2605541, which will support regulatory submissions and evaluate the new drug’s safety, efficacy and differentiation.

Encouraged by the phase 1 and 2 clinical trial data for LY2605541, Lilly hopes to present phase 3 data and gain regulatory approval in 2014.

Enrique Conterno (pictured), President of Lilly Diabetes, said: “Boehringer Ingelheim is an important partner in our strategy to provide a broad portfolio of diabetes medicines, and our diabetes alliance remains strong.

“There is no group of patients with whom Lilly has a deeper history than those impacted by diabetes. If approved, this basal insulin analogue will be an important addition to the Lilly portfolio.”

Eli Lilly, the first company to commercialise insulin, has a long history of innovation in diabetes treatment.

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.