CEO Dan Bradbury gave a corporate overview of progress at Amylin Pharmaceuticals at the Bear Stearns Health Care Conference on September 10, reviewing progress on exenatide LAR, discussing Byetta and Symlin market growth.

radbury reviewed the phase 2 data on Byetta LAR, which showed a substantial 1.7% A1c reduction from baseline (2.1% placebo) and 4 kg weight loss after 15 weeks. The ongoing phase 3 trial is a 30-week open-label, randomized, noninferiority study (n=300) against Byetta BID (twice daily) that will be completed in the fourth quarter of 2007.

Bradbury explained the mode of action of the drug, and discussed the relationship with their partner, Alkermes which supplies some of the technology in the Byetta LAR manufacturing process (LAR is impregnated into microspheres of a Medisorb polymer formulation co-developed by Alkermes, allowing release of the drug over 2-3 months). Alkermes is transferring the necessary technology to the new Amylin facility being built in Ohio at “record

pace.” He mentioned that the therapy being employed in the phase 3 trial involves layering subtherapeutic doses in order to ultimately reach therapeutic concentrations of drug.

As in the original phase 3 Byetta trials, all patients in the phase 3 LAR study will have the opportunity to go on an extension study to enable data collection on long-term use of the drug.

Also in the pipeline is a phase 1 intranasal formulation of exenatide (being co-developed with Nastech).
Bradbury cited a study looking at the use of Byetta as a first-line monotherapy for patients currently on a diet and exercise regimen. This represents a potential new market of about 9 million patients.

Regarding Symlin, Bradbury noted the expected new indication for use with basal insulin rather than
mealtime insulin only.  Amylin expects FDA approval for the indication before the end of 2007.

Most endos and primary care physicians are aware of Symlin. He stated that 50% of Symlin prescriptions were from PCPs. With the new pen delivery system expected at the end of 2007, they are expecting continued increases in Symlin’s use.