Esperion Therapeutics (ESPR) - Get Esperion Therapeutics, Inc. Report and the U.S. Food and Drug Administration failed to reach agreement on a definitive approval path for the company's cholesterol-lowering pill, sending shares down 27% in Tuesday's after-market trading session.
The impasse centers around the need for a cardiovascular outcomes study to determine the benefit of treatment with Esperion's ETC-1002. The company wants to move quickly so it proposed a plan to conduct a phase III study using LDL-C lowering as a surrogate, but still approvable, efficacy endpoint. The large cardiovascular outcomes study would still be conducted to confirm ETC-1002's benefit, but after the drug secures U.S. approval.
FDA officials would not sign off on Esperion's plan, raising the possibility of an extra-long development pathway for ETC-1002.
In a statement issued Tuesday after meeting with the FDA, Esperion said the agency "did not provide clarity on a regulatory pathway for an LDL-C lowering indication in the U.S. in statin intolerant patients at this time."
Esperion added that FDA wanted flexibility to change its mind on an approval standard for ETC-1002 depending on potential changes in the standard of care.
If LDL-C cannot be used as a surrogate endpoint for approval, Esperion would have to conduct the cardiovascular outcomes trial before submitting ETC-1002 for approval. This would delay the approval submission to 2022, the company said.
Esperion expects to end the year with $220 million in cash, enough to fund operations into 2019, including the phase III studies using LDL-C as the efficacy endpoint. The company would have to raise additional money to complete a cardiovascular outcomes study.
Esperion shares fell 27% to $11.75 in Tuesday night trading.
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