The drug: Bydureon (exenatide extended-release)
The disease: Type 2 diabetes
The developers: Amylin Pharmaceuticals, Eli Lilly and Alkermes
Peak projections: $1 billion (BMO Capital Markets) to $3 billion (Deutsche Bank)
The FDA twice sent the developers of Bydureon complete response letters in 2010, but the companies have turned a corner this year with a European green light for the long-acting diabetes drug and data that address heart safety concerns about the treatment. Yet the court struggles between the two lead developers of the drug, Eli Lilly ($LLY) and Amylin ($AMLN), have added a sour twist to the story.
The success of Bydureon, a long-acting version of the Amylin and Lilly diabetes drug Byetta, has implications for the companies' position in the increasingly competitive market for a class of drugs known as the GLP-1 receptor agonists. Novo Nordisk has been eating into the companies' Byetta business with its rival GLP-1 drug Victoza.
Yet Bydureon could be the first FDA-approved drug from this class that is injected once per week. The FDA is expected to complete its review of Bydureon by Jan. 28, and an approval could help Lilly and Amylin regain some lost ground in the GLP-1 market because of the dosing advantages over the existing meds. Alkermes ($ALKS), the drug-delivery specialist, provides the tech to prolong the availability of the drug in patients' systems, and it is due royalties on sales of Bydureon.
While Bydureon has made progress this year, Amylin and Lilly have feuded in court over Lilly's deal with Boehringer Ingelheim to promote the latter company's diabetes drug linagliptin. Yet the case also shows just how much is at stake for these companies in the blockbuster market for diabetes drugs.