Shire Shares Jump on Trial News of Possible Blockbuster

By Denise Roland 

LONDON--Shares of Shire PLC jumped more than 5% after the pharmaceutical company said it would resubmit its potential blockbuster dry-eye drug lifitegrast to U.S. regulators, based on positive results from a recently completed clinical trial.

Earlier this month, the Food and Drug Administration decided against an early approval for the drug, saying it needed to see more clinical-trial evidence.

The Dublin-based company said that, in the recently completed phase-three trial called OPUS-3, the drug improved patient-reported symptoms of dry-eye disease compared with a placebo as early as two weeks into treatment, with the effect lasting throughout the 12 weeks of the trial.

Shire said it planned to use the data as part of the resubmission of lifitegrast in the first quarter of 2016 and that, if approved, the drug could still launch next year. The company said it would also provide more data on the quality of the drug in response to questions posed by the FDA during the initial review.

Philip J. Vickers, head of research and development at Shire, said he believed the data from OPUS-3 "will satisfy the FDA's request for an additional clinical-data study."

Ronny Gal, an analyst at Bernstein, said the new data should be enough for approval, which he expects to come in the third quarter of 2016. The "FDA had clearly tied approval of lifitegrast to OPUS-3, which made sense given Shire were looking for both a signs and symptoms claim on the label," he said.

Shire conducted OPUS-3 "as a safety blanket," according to Chief Executive Flemming Ornskov, to add force to evidence that lifitegrast was the first ever drug to treat the symptoms of dry-eye disease.

An earlier study, called OPUS-2, had already demonstrated that the drug relieved dry-eye symptoms but failed to show lifitegrast treated the physical signs of the disease. Another phase-three study, OPUS-1, generated the opposite result, showing that lifitegrast treated signs but not symptoms.

Mr. Ornskov said OPUS-3 was important because it showed the result in symptom-relief could be replicated. All three clinical trials together will form the basis for the resubmission, he said.

The success of lifitegrast is a key plank in Shire's ambition to increase sales to $10 billion by 2020 from around $6 billion currently. Analysts have forecast that peak annual sales of the drug, which is the first shown to relieve the symptoms of dry-eye disease, could hit $1.5 billion.

In London trading, Shire shares were up as much as 7.4% to GBP49.50 ($76.03) on the news and at midsession were up 5.6% to GBP48.68.

Write to Denise Roland at [e-mail]

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October 27, 2015 09:15 ET (13:15 GMT)

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