Bydureon had another setback this week, but the extended-release technology that Waltham, MA-based Alkermes ($ALKS) provides for the experimental drug remains important to long-term success of the treatment. This was almost lost in reports that the weekly type 2 diabetes drug missed its main goal of non-inferiority in a head-to-head study with an approved treatment, Victoza.
Bydureon is a weekly formulation of Byetta, which is Amylin Pharmaceuticals' ($AMLN) and Eli Lilly's ($LLY) approved treatment for Type 2 diabetes. The weekly version uses Alkermes's polymer microsphere technology to make it last longer. The FDA approved Byetta for the market in 2005 as a treatment that is injected twice per day. Yet Byetta lost some market share last year to Novo Nordisk's Victoza, which the FDA approved in January 2010 as a treatment that patients inject once a day.
Bydureon, if approved, might help its developers regain an edge in this market because it lasts longer. Deutsche Bank analyst Robyn Karnauskas told Dow Jones Newswire that the convenience of weekly injections of Bydureon would have the greatest impact on sales if the drug gets approved. (The treatment and Victoza belong to a class of drugs called GLP-1 receptor agonists. They are synthetic versions of a hormone found in the saliva of the Gila monster). Karnauskas's analysis provides an 85 percent probability of Bydureon sales peaking at $2.5 billion by 2020.
For a chance to gain FDA approval, however, Bydureon has to be safe. The approval of the treatment was delayed in October 2010, when the agency asked for data about the drug's potential impact on heart rhythms. The developers of the drug plan to respond to the FDA's request for this information in the second half of 2011. The results of the latest study comparing Bydureon with Victoza will not be part of the data package for approval.