Esperion Stock Plummets as Updates on ETC-1002 Prove Not Enough for Investors
September 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff
ANN ARBOR, Mich. -- Esperion Therapeutics, Inc. ’s stock plummeted nearly 35 percent this morning after the company announced it will separately assess patients with statin intolerance following Phase II results.
Esperion said it plans to conduct multiple Phase III clinical trials to “separately evaluate patients with statin intolerance, as well as patients who are inadequately treated despite maximally tolerated statin therapy.” The company said it believes the separate trials will “leverage the profile of ETC-1002 to differentiate the drug in the statin intolerant patient population, while also preserving the opportunity to develop the drug as an add-on to maximally tolerated statin therapy.” The company said it is working on the design of the Phase III programs and has plans to finalize the trial parameters in the first half of 2016.
Esperion said it will conduct efficacy and safety trials. Additionally, the FDA has encouraged Esperion to initiate a cardiovascular outcomes trial that would be complete by the time the company seeks regulatory approval. The FDA said the trial is necessary to alleviate “any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval.” Esperion said it intends to initiate a long-term safety study for ETC-1002 by the end of 2015.
ETC-1002 is designed to lower cholesterol for patients who have not had success using statins, such as Pfizer Inc. ’s Lipitor. The compound is a first-in-class, oral, once-a-day drug that lowers cholesterol by inhibiting ATP citrate lyase (ACL), a key enzyme that is involved in the creation of cholesterol.
In August, Esperion announced the U.S. Food and Drug Administration (FDA) confirmed LDL-C as an acceptable clinical surrogate endpoint for its trial therapeutic, ETC-1002.
Although the company is moving forward with its drug, stock investors seem to be wary, selling off Esperion stock. Esperion is at $22.86 per share, down 34.85 percent from Monday’s closing price of $35.09 per share. Over the past year, the stock has shown some volatility. It saw a high of $120.96 per share earlier this year. A Yahoo! Finance report shows Esperion has “underperformed the market, as the stock is down 13 percent year to date.”
Over the summer analysts were high on Esperion’s stock, giving it a “buy” rating.
Despite the stock’s decline, Tim Maylben, president and chief executive officer of Esperion, said the company is focused on delivering a Phase III program that will meet regulatory approval in the United States and in other countries around the world.
"We continue to advance toward the potential worldwide approval of ETC-1002 as a new oral, once-daily treatment option. We remain confident that patients, physicians, and payers will welcome a new, oral LDL-C lowering therapy, especially for those patients who are considered to be intolerant of statin therapy,” Maylben said in a statement.
Esperion’s drug, if approved, will face some entrenched competition. The FDA recently approved Regeneron Pharmaceuticals, Inc. and Sanofi 's Praluent for cholesterol. Amgen ’s Repatha is expected to be approved this month to treat cholesterol. Aegerion Pharmaceuticals, Inc. (AEGR) is also marketing Juxtapid, used to treat homozygous familial hypercholesterolemia (HoFH), but that drug has a price tag of $295,000 per year, compared to Praluent’s $14,600 annual price.
Joel Beatty, an analyst with CitiVelocity, said Esperion could still have a solid drug on the market, if it’s approved. He said it would take less than 6 percent market penetration to achieve $1 billion in annual sales, assuming a $3,000 per year price .