[1]pic thx to hobvias sudoneighm flickr creative commons
In a surprising move, Eli Lilly discontinued further development of a cholesterol-lowering treatment that some Wall Streeters thought would become a blockbuster medicine. A data monitoring committee determined that the drug, known as evacetrapib, simply wasn’t working [2] and so was unlikely to meet the primary endpoint in a key late-stage clinical trial.
Interestingly, two other drug makers have similarly failed to develop the same type of drug, known as a CETP inhibitor, which has been tested to raise HDL, or good cholesterol. Several years ago, a Pfizer drug famously flopped and the episode raised skepticism about whether such an approach can work. And Roche later abandoned its own version.
So what now? For Lilly, the decision places more pressure to succeed with other pipeline products, notably an Alzheimer’s drug. The news is also likely to raise doubts about a CETP drug that Merck is developing. But for other companies – notably, Amgen, Regeneron Pharmaceuticals and Sanofi – this may be a gift, since their new injectable treatments will face less competition.
Here is what some of the wags are saying:
As Sanford Bernstein analyst Tim Anderson explained in a research note, Wall Street was more optimistic about the Lilly and Merck drugs. Why? Unlike the drugs that failed, these drugs not only demonstrated an ability to raise good cholesterol, but also to lower LDL, or bad cholesterol. There is established benefit, of course, to lowering LDL, and both drug makers designed their studies to show a cardiovascular benefit by doing so.
This approach “seemed to raise the odds of successful trial outcomes,” he wrote. But he added that dismissing the Merck drug may be premature, if only because Merck is testing its drug in a larger patient population than Lilly did – 30,000 people versus 12,000. He added that the Merck trial is also including patients who experienced fewer cardiovascular problems, suggesting the potential for better outcomes.
Final results, however, will not be known until sometime in 2017, but Merck could release interim data. ISIEvercore analyst Mark Schoenebaum wrote in his own note that, “from a safety perspective, one of the questions around [the Merck drug and not the Lilly drug] has been the persistency in the body after the drug has been stopped. But if the safety from the [Merck] trial looks good, it may not be an issue.”
But Leerink analyst Seamus Fernandez is not so sanguine. After speaking with Lilly management, he wrote that the Lilly drug successfully lowered bad cholesterol and raised good cholesterol. Yet the drug failed to reduce cardiovascular events – such as heart attacks – as hoped.
“We believe this is negative news” for the Merck drug, he wrote. “…The perception of the CETP inhibitor as a class is now in serious question again with three out of four major CETP outcome trials having failed.”
Meanwhile, the new PCSK9 inhibitors sold by Amgen, Sanofi and Regeneron are expected to be beneficiaries. As Piper Jaffray analyst Joshua Schimmer explained, these drugs greatly reduce bad cholesterol. So in his view, the news about the Lilly drug “does not affect the chances of success” for outcomes studies these drug makers are conducting on their medicines.
Another beneficiary may be Esperion Therapeutics, which is developing an oral version of these new injectables. A pill would cost less and, therefore, become popular with payers. But, if true that the Lilly drug did not provide a heart benefit, the FDA may ask Esperion to provide extra study data about cardiovascular outcomes.
There is a wrinkle for Amgen, though. Just last month, the biotech paid $300 million to buy a biotech called Dezima and one of the key drugs in its pipeline is… you guessed it… a CETP inhibitor. This raises the question of whether Amgen made a bad bet. Timing is everything, yes? Whether the company will run the risk of spending more money to learn the same lessons as three other drugs makers remains to be seen. Sometimes, a little hedge can be a big mistake.