Once-weekly Byetta market may be huge, pending potential new diabetes drug safety concerns (AMLN, SNY, LLY, ALKS, NVO)
Amylin Pharmaceuticals Inc. (AMLN) along with partners Eli Lilly & Co. (NYSE: LLY) and Alkermes Inc. (Nasdaq: ALKS) announced its new drug application for a once-weekly version of Byetta for diabetes has been accepted for review by the FDA, a move that may eventually help invigorate growth for the franchise.
The catalyst may be muted, however, as the announcement comes amid safety concerns among other drugs that are long-acting treatments for diabetes. Analysts became concerned last week about potential links between the Sanofi Aventis (NYSE: SNY) Lantus long-acting insulin product — the second-biggest seller in its product lineup — to cancer risk, sending its shares and those of competing manufacturers including Novo Nordisk Inc. (NVO) lower.
The journal Diabetologia, associated with the European Association for the Study of Diabetes in late June published four studies that made a possible link between Sanofi’s Lantus and cancer. The studies fell short of making a direct link, but they raised plenty of questions that were picked up by Wall Street.
Byetta works differently than long-acting insulin treatments including Lantus, but analysts became concerned that more questions could be asked about many drugs, if not the entire class of long-acting diabetes drugs.
Byetta had faced another big safety worry over the past 12 months that arguably held back it sales; a potential link to pancreatitis. But Amilyn and and Eli Lilly announced retrospective study data last month that involved 260,000 patients that did not show an increased risk of pancreatitis for Byetta patients, vs. patients taking other diabetes drugs.
Assuming that Amylin can make a strong case that Byetta is different from other long-acting diabetes treatments for which potential safety concerns have been raised, the new weekly formulation of the drug may help spur recently stagnant sales.
Byetta will not replace insulin in patients whose diabetes requires insulin treatment. But there are 20 million people in the U.S. with Type 2 diabetes, and it’s fair to say that many of them might be interested in a once-weekly drug that can help them control their blood sugar levels, assuming they feel comfortable that it’s safe. – Mike Tarsala
