The official title of Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY), and Alkermes' (Nasdaq: ALKS) clinical trial was "A Randomized, Phase 1, Three-Period, Placebo- and Positive-Controlled, Double-Blind, Crossover Study to Assess the Electrophysiological Effects of Exenatide at Therapeutic and Supratherapeutic Concentrations on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects," or ARPTPPPCDBBSAEEETSCLEQIHS for short.
"*Bleep* You, FDA!" would have been much more appropriate.
The companies' diabetes drug Bydureon seemed destined for an approval last October, until the Food and Drug Administration sprung a new and seemingly unnecessary trial on them.
Eight months and who knows how many millions in lost sales later, the pharmaceutical trio has completed the requested trial. The drug, even at levels above what patients would normally get, didn't prolong the QT interval, a measurement of potential heart problems.
The companies plan to submit the results to the FDA in the third quarter of this year. Assuming a six-month review cycle, Bydureon could finally be on the market in the first quarter of next year.
The overly cautious FDA's delay allowed Novo Nordisk's (NYSE: NVO) Victoza to take market share from Lilly and Amylin's Byetta. Bydureon, a once-weekly formulation of Byetta, should be able to take some or all of that back, but it'll be more difficult than a straight switch from Byetta to Bydureon.
The only good news coming during the delay is that Novo Nordisk has grown the GLP-1 class of drugs. Two injections a day is a distinct disadvantage for Byetta, compared to oral medications such as Merck's (NYSE: MRK) Januvia, Takeda's Actos, and Onglyza from Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN). If Victoza was able to increase the market by reducing that to just one injection a day, Bydureon's once-weekly format should be able to expand it even further.
That's assuming, of course, that the FDA doesn't find something else to complain about.
The FDA may be a little cautious, but Fool analysts think these two small caps are too important for the government to let them fail.
