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Amylin to pay up to $1.6 billion to sever ties with Lilly

pharmafile | November 8, 2011 | News story | Research and Development, Sales and Marketing Amylin, Bydureon, Byetta, R&D, lilly 

Amylin will pay up to $1.6 billion to end its diabetes pact with Lilly after a difficult year for the two firms. 

Both companies have agreed to terminate their alliance for the exenatide diabetes franchise and responsibility for the worldwide development of the drug will pass to Amylin.

This process will start in the US later this month and progress to all markets by the end of 2013. 

As part of the agreement Amylin will pay Lilly $250 million upfront and up to $1.2 billion from the sales of exenatide products, in exchange for full rights to the drug and its successors.

It could also pay an additional $150 million in milestone payments if the FDA approves a long-acting form of the diabetes treatment, which is currently in Phase II trials.

The pact between the firms has been in place for over a decade, but earlier this year Amylin filed suit against Lilly after the firm partnered with Boehringer Ingelheim, a rival in the diabetes field, on their new diabetes pill Trajenta.

As part of the deal Amylin has now dropped this lawsuit, but no further details were given about the litigation.

Exenatide is currently licenced to help type II diabetics keep their blood sugar levels low under the brand name Byetta, and was the first injectable GLP-1 agonist to be approved by the FDA in 2005.

The two firms also brought out a longer acting once-weekly form of the drug to the European market earlier this year under the brand name Bydureon, but had greater difficulty in convincing the FDA, which has asked for more information on the drug.

Current mid-stage trials are ongoing for a once-monthly form of Bydureon, and this will now be passed on to Amylin and its other partner for the drug Alkermes, which has a royalty stake in the drug. 

Enrique Conterno, president of Lilly Diabetes, said: “Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance’s long-held goal of making [the drug] available to patients in the US.

“Looking forward, Lilly Diabetes remains committed to providing a comprehensive portfolio of diabetes treatment options for patients through our currently marketed products and robust clinical pipeline,” he added.

Ben Adams 

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