Two more clinical trials go against Lilly

In the midst of Eli Lilly and Co.’s surprisingly positive news about its experimental Alzheimer’s drug, the company suffered two other setbacks with former stars of its pipeline.

Clinical trial results released Aug. 26 showed Lilly’s blood thinner Effient did not prove any safer for heart patients than did Plavix, the blockbuster that saw its patent expire in May.

That’s a big missed opportunity for Lilly, which has been struggling to differentiate Effient from Plavix, as well as from a new competitor, Brilinta, recently launched by United Kingdom-based AstraZeneca plc.

It’s also disappointing because Lilly is in the midst of losing patent protection on five blockbuster drugs from 2010 to 2014, which will sap the company of roughly $9 billion in annual sales.

Effient sales topped $226 million during the first half of this year, up 77 percent from the same period last year. But sales fell from $115 million during the first quarter to $111 million in the second quarter.

Effient is approved for patients who already have had their arteries opened to treat heart attacks and other serious heart events.  But the latest trial, called TRILOGY, was in patients who are being treated only with drugs. Those patients, knwon as medicall managed patients with acute coronary syndrome, or ACS, represent a huge and largely untapped market for Effient.

"The failure of TRILOGY comes as a blow to the Effient franchise because these results essentially prove to doctors and payers that Effient is no better than generic Plavix in the larger population of medically managed ACS patients," wrote Goldman Sachs analyst Jami Rubin in an Aug. 26 investor note.

Plavix, which became the standard treatment for heart patients in broad categories, reached peak sales of more than $8 billion—success that five years ago had analysts salivating about Effient, which was then known as prasugrel.

But now, most analysts expect Effient annual sales to peak in 2016 at $1.2 billion—which Lilly splits with its development partner on the drug, Japan-based Daiichi Sankyo & Co. Ltd.

Effient “has seen limited uptake in most markets, in part due to the widespread availability of generic alternatives to Plavix in the [European Union] during most of that time,” wrote Deutsche Bank analysts Barbara Ryan and George Drivas in a July 25 research note. “Competitive pressures have also intensified recently in the U.S. with the patent expiry for Plavix in May 2012.”

Lilly also halted testing on a new treatment for schizophrenia that was supposedly designed to be Zyprexa-without-the-side-effects. Pomaglumetad methionil, also known as mGlu 2/3, was not showing a significant effect on patients in a large-scale clinical trial.

In July, the company announced the drug had failed in another large-scale study. And even before that, the drug did not appear effective in a smaller Phase 2 clinical trial.

Analysts expected only $250 million to $300 million in peak sales of the drug. That’s a far cry from peak sales of Zyprexa—which was effective against schizophrenia but was associated with weight gain and diabetes—of $5 billion annually.

“I’m disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness,” Jan Lundberg, president of the Lilly Research Laboratories, said in a statement.