Merck succeeds where others failed, but skepticism abounds
- In a surprise result, Merck & Co. announced Tuesday its cholesteryl ester transfer protein (CETP) inhibitor anacetrapib reduced major coronary events in the REVEAL outcomes study.
- Merck did not disclose the data, but will unveil the full analysis at the European Society of Cardiology meeting on Aug. 29.
- The big pharma said it plans to review the complete results with outside experts to determine whether to file the drug with the Food and Drug Administration, as well as other regulators.
Despite a swath of failures for the CETP inhibitor space, Merck continued to pursue anacetrapib with the four-year-long, 30,000-patient REVEAL study.
Bets on the class had previously resulted in high-profile failures for companies like Eli Lilly & Co., Pfizer, Roche and Amgen, which have virtually all terminated their CETP programs.
Many questioned Merck’s choice to stay in the class. Even with the surprise positive results in hand, Merck doesn't seem completely sold on the drug either.
"Whilst the headline is positive, the press release implies that there may be significant questions over the risk:benefit of anacetrapib in the REVEAL study," wrote Jefferies analyst Jeffrey Holford in a note to clients on Tuesday.
"This could either be due to lower than expected efficacy, adverse events seen in the trial, or a mix of these making the balance of risk:benefit less certain. The company also reminded investors in the release of the accumulation of anacetrapib in adipose tissue, which may also be a major concern for regulators," he added.
Merck has plenty of reasons to be skeptical. The class has been plagued by failures, and without full data it’s hard to tell whether REVEAL was a slamdunk or just minimally positive.
Beyond that, cholesterol drugs have not had an easy time unseating statins as the standard-of-care. Just take a look at the beleaguered PCSK9 class, which showed potent reduction in LDL-C levels, or "bad" cholesterol. Despite having some positive cardiovascular outcomes data in its corner, the PCSK9 class has struggled to gain any traction.
While anacetrapib is an oral cholesterol drug (and the PCSK9 inhibitors are injectable), it is unlikely to offer much competition to the struggling PCSK9s and more likely could have the same commercial fate. Cheap, generic statins appear — for now — to remain kings of the cholesterol market.
- Merck & Co. Press release
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