FDA wants more info on pen delivery for Amylin's Bydureon
Amylin ($AMLN) is looking to expand Bydureon, its Type 2 diabetes drug, with a new drug delivery method: pre-filled injection pens instead of syringes. However, the FDA is asking the company for more data before deciding whether to allow the potentially lucrative new form of the drug, Reuters reports.
Amylin said it will comply with the FDA's request for "incremental device-related data," according to Reuters, and the company hopes to have the pen-delivery formulation of Bydureon on the market by 2013.
The syringe-based Bydureon, itself a once-weekly formulation of Amylin's Byetta, got its FDA approval in January. It requires patients to fill their own syringes and inject themselves, however, so the use of a pre-filled, fixed-dose pen for delivery could expand the drug's adoption and boost patient adherence. Amylin licensed the extended-release tech from Alkermes ($ALKS), and after enduring continued delays in Bydureon's approval, the company is looking to expand its available platforms.
The potential of a new delivery method for Bydureon could play into the protracted bidding on the up-for-grabs Amylin. The company is fielding offers from Big Pharma left and right, with offers valuing the company at up to $4.7 billion. The main draw: Amylin's diabetes drugs, which analysts say could bring in up to $1.5 billion per year.
- read the Reuters news