- In response to Shire's submission package for lifitegrast, the FDA sent the company a Complete Response Letter (CRL) requesting an additional clinical study.
- Lifitegrast, which is intended to treat chronic dry eye disease, has long been considered one of the strongest candidates in Shire's pipeline.
- Analysts have pegged lifitegrast as a possible blockbuster drug, with the potential to garner more than a billion dollars per year in sales.
For the past three months, Dublin-based Shire has been attempting to acquire Baxter spinoff Baxalta, based in Deerfield, IL. These efforts have been unsuccessful so far and this rebuff from the FDA definitely doesn't help.
However, Shire has already completed a phase 3 study, which it hopes to use to fulfill the FDA's latest request. The company is now waiting for the results, which should be available by the end of the year, allowing Shire to resubmit during the first quarter of 2016.
"We were disappointed, but will soon have data from the Phase 3 study, OPUS 3," said Shire CEO Flemming Ornskov in a statement. "OPUS-3 has now been completed and top-line data are expected before the end of the year. If the study is positive, we plan to refile our liftegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year."
Despite this setback, there's a decent chance that lifitegrast can still win approval. Over 29 million people in the U.S. have some form of dry eye disease, and there is a demand for new treatment options. But on a different note, Shire's pursuit of Baxalta continues to be troubled by its stock decline. Shire shares have fallen more than 20% since the beginning of August.
Regardless, Shire is persistent. If not Baxalta, then Shire may go after another company, such as Radius Health, which is smaller than Baxalta with a market value of a little less than $3 billion.