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Bydureon

AstraZeneca PLC

Drug Names(s): AC2993/exenatide LAR, long acting synthetic exendin-4, exenatide once weekly (EQW)

Description: Bydureon is a once-weekly formulation of exenatide (Byetta), given by subcutaneous injection, which utilizes Alkermes's Medisorb sustained release drug delivery technology. The compound requires reconstitution prior to administration.

Medisorb technology is able to encapsuate small molecules, peptides and proteins in microspheres made of biodegradable polymers. With extended-release profiles lasting from days to months, these microspheres are designed to eliminate the need for frequent dosing.

Exenatide is a peptide that exhibits multiple anti-diabetic actions of the mammalian hormone glucagon-like peptide (GLP-1). GLP-1 is an incretin hormone secreted in the small intestine and colon in response to food intake. It enhances insulin secretion when glucose levels are high, suppresses inappropriate glucagons secretion (glucagon has the opposite effect of insulin), slows gastric emptying (slowing entry of ingested nutrients into the bloodstream, hence limiting post-prandial glucose), and via actions on the brain is thought to promote satiety.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

Amylin and Alkermes
In May 2000, Amylin signed an agreement with Alkermes for the development, manufacture and commercialization of Bydureon.

Alkermes will receive 8% of net sales from the first 40 million units of Bydureon sold in any particular year and 5.5% of net sales from units sold beyond the first 40 million for that year. In addition, Alkermes will receive a $7 million milestone payment upon the first commercial sale of Bydureon in the U.S. and an additional $7 million milestone upon the first commercial sale in Europe.

Amylin and Eli Lilly
In September 2002, Amylin and Lilly entered into a Collaboration Agreement for the global development and commercialization of exenatide. This agreement includes Byetta and any sustained release formulations of exenatide.

Lilly agreed to pay $80 million up front to Amylin and purchase $30 million of Amylin stock. Including other milestone...See full deal structure in Biomedtracker

Partners: Alkermes plc Eli Lilly & Company Bristol-Myers Squibb Company 3SBio Inc.


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