Setbacks

Still pondering an M&A move, Gilead’s R&D team outlines a Q3 lineup of setbacks on 3 pipeline drugs

Gilead CEO John Milligan

Gilead CEO John Milligan

Hit on one side by slumping hep C revenue and on the other side by high expectations for its pipeline effort, Gilead grimly hung on to simtuzumab after the LOXL2 enzyme blocker flopped in two straight studies. Now the Big Biotech has added several more failures to the roster and put the five-time loser on the shelf for good.

And that’s not all.

Two more drugs also failed a lineup of clinical trial tests, leaving Gilead $GILD looking weaker on the R&D front at precisely the time it needs to show strength. In addition to simtuzumab, the biotech also wrote off the late-stage drug GS-5745 for ulcerative colitis and Crohn’s. And it’s top cardio prospect failed a study as well, significantly reducing its chances of becoming the big new drug that Gilead needs as hep C wanes. Meanwhile, its Q3 R&D expenses spiked, largely due to the $200 million payment it just made to Nimbus.

Add it up and Gilead now more than ever needs to do something big for the pipeline, but CEO John Milligan continued to insist that the company will bide its time in finding the right deals. He noted:

(O)ur interest in partnerships and potential acquisitions is not limited to oncology, and we are considering opportunities where there is strong science and where we see the possibility of developing a truly differentiated product. We’ve been going through an extensive internal review of programs and opportunities, and an important aspect of our approach is that we remain open-minded, but disciplined. So while we have the balance sheet to execute on multiple opportunities, we will keep the bar high.

Gilead CSO Norbert Bischofberger

Gilead CSO Norbert Bischofberger

Gilead R&D chief Norbert Bischofberger was left to sound taps on the drug trials during the Q3 review Tuesday evening, starting with simtuzumab, which has now failed 5 studies, including three recent 96-week attempts:

The data indicate that, while safe and well-tolerated, there is no evidence of efficacy in one study in primary sclerosing cholangitis and in two studies in NASH. One NASH study was in patients with cirrhosis and one was in patients with liver (20:54) fibrosis. Consequently, we will not develop simtuzumab any further in these or any other indications. We will present these data at future conferences.

The drug already failed for pancreatic cancer and idiopathic pulmonary fibrosis.

As for GS-5745, an anti-MMP-9 antibody, we stopped a Phase II/III study in patients with ulcerative colitis because of the lack of efficacy. This decision for the planned interim DSMB analysis after the first 150 patients had been enrolled, that the study met pre-defined futility criteria. Also, and not unexpectedly, there was no evidence of benefit of GS-5745 in a Phase II study in patients with Crohn’s disease. Consequently, we will not further pursue GS-5745 for ulcerative colitis or Crohn’s.

And then came the cardio drug eleclazine.

Eleclazine, or GS-6615, failed to meet its primary endpoint in a study of patients with ventricular tachycardia, ventricular fibrillation, or VT/VF, and implanted cardioverter-defibrillators. Patients were randomized to two doses of eleclazine or placebo. The primary endpoint was the number of electrical interventions, including shocks and pacing, by the implanted device. And there was no evidence of efficacy of eleclazine compared to placebo. Consequently, we will not develop eleclazine any further for VT/VF. Evaluation in long QT-3 syndrome and in hypertrophic cardiomyopathy is continuing.


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RAPS Regulatory Convergence 2017