Results, Setbacks

Novartis-allied Ophthotech blitzed after a pair of PhIII disasters for wet-AMD franchise drug

Opthotech CEO David R. Guyer

Opthotech CEO David R. Guyer

Ophthotech $OPHT had everything going for it when it struck a $1 billion-plus partnership with Novartis on its late-stage wet-AMD drug Fovista back in 2014. The anti-PDGF — designed to go hand-in-hand with an anti-VEGF like Lucentis — had successfully navigated a positive Phase IIb. And a successful IPO in 2013 added cash as investors bought into its promise. Novartis itself agreed to pay $330 million in upfront and near-term cash to get the deal done — a sizable sum.

But the odds-on winner turned into a disappointing loser this morning as Ophthotech and Novartis spelled out a serious failure in two late-stage studies, sending its share price reeling. Its stock cratered instantly, plunging 82% in pre-market trading.

In one of the Phase III studies, the Fovista/Lucentis combo group actually did slightly worse on the primary visual acuity score than Lucentis alone. Combine the two Phase III studies and there was only a tiny, inconsequential gain in visual acuity.

The combination therapy also failed to distinguish itself on pre-specified secondary endpoints, completing a rout for the partners.

The reveal marks a bitter setback for Novartis as well, which counted Fovista as one of its top late-stage efforts that would help the pharma giant counter growing generic competition.

There’s still one more shot on goal for this drug. A Phase III combo study with Eylea is set to read out next year. But Regeneron recently experienced a mid-stage setback on the same PDGF/VEGF approach, and washed their hands of the whole thing after repeatedly discounting their chances of a success to analysts. Another failure by Ophthotech would likely ice the combo theory altogether, leaving the biotech in the dust.

Regeneron has shifted its gaze to Ang2 as the most likely bet on improving on Eylea. “We now look to Eylea/Ang2 combination to bolster the franchise,” notes Jefferies’ Biren Amin, “for which the PII trial ONYX continues to enroll pts.”

“We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD,” commented Opthotech CEO David R. Guyer. “We are thankful to the patients and clinical investigators and their staff for participating in the trials. We will continue to analyze the data from these two studies to better understand the trial results.”


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