Shire PLC plans to resubmit its application for US approval of a potential blockbuster drug for dry-eye disease next year after regulators unexpectedly asked for additional testing and information.
“We were disappointed” by the feedback on the medicine, called lifitegrast, CEO Flemming Ornskov said in a statement, adding that the Dublin-based drugmaker would soon get data from an advanced study called Opus-3 that might help with a resubmission to the US Food and Drug Administration (FDA).
Lifitegrast is one of the medicines in development that Shire is counting on to meet a goal of boosting sales to US$10 billion by 2020 from about US$6 billion last year.
Annual revenue from the drug could reach US$723 million by that date, according to the average of analyst estimates compiled by Bloomberg.
The company said late on Friday that the FDA had requested another clinical study and data on product quality, a setback after the drug had won priority review status, shortening the review process to eight months from the standard 12 months.
“Opus-3 has now been completed and top-line data are expected before the end of the year,” Ornskov said in the statement yesterday. “If the study is positive, we plan to refile our lifitegrast submission in the first quarter of 2016, and will remain on track for the planned launch next year.”
Opus-3 is “very likely” to show that it improves symptoms in patients, said David Evans, an analyst at UBS Group AG in London.
This would add evidence to two previous studies, neither of which hit both primary goals, he said.
In a research note earlier this month, Evans correctly predicted the FDA would want more data for the drug, which may at its peak hit US$2 billion in annual sales. He also said he expects it to eventually reach the market.
“We see a high probability of refiling and ultimate approval,” Evans said in the note.
Shire said that in the US there are 29 million adults who have the symptoms of dry-eye disease. The condition makes it more difficult to perform certain activities, including using a computer or reading for an extended period of time. Lifitegrast, if approved, would compete with Allergan PLC’s Restasis, which is estimated to bring in more than US$1 billion in sales this year.
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