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Drug Names(s): Exenatide, Synthetic exendin-4, AC2993, LY2148568
Description: Please also see Bydureon, the once-weekly formulation of exenatide.
Byetta, or exenatide, is a 39-amino acid peptide that exhibits multiple anti-diabetic actions of the mammalian hormone glucagon-like peptide (GLP-1). It is given via twice-daily injection.
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.
Amylin’s exenatide is a synthetic version of a peptide derived from Gila monster lizard venom. Amylin had acquired exclusive patent rights to this compound and another exendin in October 1996 from their discoverer. While GLP-1 has a half-life less than 2 minutes, exenatide has a terminal half-life of 2.4 hours.
Deal Structure: Revenue splits for this drug are BioMedTracker estimates.
Amylin and Eli Lilly
On September 20, 2002, Amylin partnered with Eli Lilly to develop and market exenatide. Lilly agreed to pay $80 million up front to Amylin and purchase $30 million of Amylin stock. Including other milestone fees and payments related to the success of the long acting formulation of exenatide, the deal could be worth approximately $300 million to Amylin. Lilly and Amylin agreed to share profits for exenatide, and Lilly agreed to help Amylin develop its sales force in anticipation of Symlin marketing.
In May 2008, Amylin and Lilly entered into an addendum to their co-promotion agreement, or the Addendum, pursuant to which Lilly added a third party sales force to co-promote BYETTA in the United States.
In April 2009, Amylin and Eli Lilly agreed to an amendment of the collaboration agreement between the parties made in September 2002. The Amendment requires Lilly to give Amylin one year...See full deal structure in Biomedtracker
Partners: Eli Lilly & Company Bristol-Myers Squibb Company 3SBio Inc.
Pink Sheet Byetta FDA Reviewers
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