|Flemming Ornskov, CEO of Shire|
One of the first deals Flemming Ornskov struck as the new CEO of Shire has soured quickly. The company says that its therapy for dry eye, lifitegrast, missed one of two key endpoints in a Phase III study, raising some serious questions about its future.
Ornskov nabbed the therapy in its buyout of SARcode last spring, paying $160 million upfront and promising a slate of unspecified milestones in the deal. But Thursday night Shire ($SHPG) was forced to concede that while the solution hit the goal for the patient-reported symptom of eye dryness compared to the placebo arm, it also missed the co-primary endpoint on reduced corneal staining, a commonly used test for the disease which regulators are likely to pay particularly close attention to.
Ornskov has been shaking things up at Shire this year, reorganizing R&D, reshaping its independent divisions around the world into a single operation and buying up biotechs to help further diversify the pipeline. The SARcode buyout was one of his initial forays into ophthalmology. And the mixed results in Phase III drew frowns from some analysts today.
"Given these equivocal results and FDA's typical need for two supportive trials, we see an uncertain approval path," Jefferies analysts wrote following the Phase III release, according to a report in Reuters. But Ornskov isn't ready to call it quits on lifitegrast.
Jason Gerberry at Leerink Swann agreed, saying that Shire would likely be forced now to add a Phase III study to the program if Ornskov expects to push ahead. He slashed potential peak sales in his model from $300 million to $125 million.
"In this clinical trial, we note that lifitegrast showed a statistically significant improvement in the prespecified symptoms of dry eye disease and is the first drug to do so in a Phase III clinical trial," Ornskov said in a statement. "We will be examining the totality of the data for lifitegrast in OPUS-2, as well as OPUS-1 and across the entire clinical trial program. We look forward to discussing the lifitegrast program with regulatory authorities."
- here's the release
- get the report from Reuters
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