Amylin Pharmaceuticals Inc. said Tuesday its once-weekly diabetes drug Bydureon topped rival Januvia in a study, but results showed it was on par with several other drugs, including the widely-used generic metformin.
Amylin shares fell 48 cents, or 2.7 percent, to $17.31 in midday trading. The stock has traded between $11.01 and $24.20 over the last 52 weeks.
The company, based in San Diego, said injectable Bydureon reduced blood sugar levels by 1.5 percent in the 820-person study, compared with a 1.2 percent reduction for patients taking Merck & Co.'s oral Januvia. But, patients taking the widely-used generic pill metformin experienced a 1.5 percent reduction while patients taking Takeda Pharmaceutical's Actos experienced a 1.6 percent reduction.
The Food and Drug Administration is expected to make a regulatory decision on Bydureon by Oct. 22. It is being codeveloped by Eli Lilly & Co. and Alkermes Inc. The drug is a once-weekly version of the twice-daily injectable drug Byetta, and a key concern for the market is Bydureon's prospects against Novo Nordisk's once-daily drug Victoza, which received FDA approval in January.
Leerink Swann Research analyst Dr. Joshua Schimmer reaffirmed a "Market Perform" rating for Amylin, saying the results are consistent with his view that Bydureon is probably on par with Victoza.
Both Victoza and Bydureon are part of the GLP-1 agonist class of drugs, which work to control blood sugar levels.
Schimmer said Bydureon will likely come out on top in the GLP-1 class, but it is difficult to determine the extent of market expansion.
"We believe the class needs to grow (about three times) to justify meaningful upside to Amylin but lack visibility that it will occur," he said.
Also, he said the comparable results with metformin will make it difficult for Bydureon to make gains as an initial diabetes treatment. Also, gaining share over orally administered Januvia despite the better results could be tough, he added.
"Results of this trial confirm the superiority of Bydureon over Januvia seen in earlier trials, but gaining share with an injectable drug over an oral drug is tough in diabetes," he said.
Meanwhile, Jefferies & Co. analyst Thomas Wei reaffirmed a "Buy" rating for Amylin, saying Bydureon as a stand-alone therapy had not been an initial assumption for most of the market.
"The real key to actual expanded use of Bydureon is and still remains the demonstration of a cardiovascular outcomes benefit," he said, citing anticipated upcoming study data. "If positive, Bydureon could be the first drug to demonstrate a reduction in cardiovascular events in diabetics, which we suspect would change the way the GLP-1 class is used."
Diabetics have a higher than average risk of cardiovascular problems, including heart attacks.
Elsewhere, shares of Alkermes, based in Waltham, Mass., rose a penny to $11.63 while Eli Lilly, based in Indianapolis, fell 9 cents to $33.78.