Shire's long-delayed ADHD drug hits another FDA speed bump

Shire CEO Flemming Ornskov

Shire's ($SHPG) plans to squeeze more sales out of its blockbuster Adderall franchise are facing another delay, as the FDA wants more data on a new long-acting ADHD treatment that has languished in agency purgatory for years.

The treatment, SHP 465, has the same active ingredient as Shire's now-generic Adderall XR but is formulated to last for 16 hours, potentially requiring just one pill a day for adults with ADHD.

After years of delay and rejection, Shire finally got some good news on the drug in April as the FDA cleared the way for a resubmission, and the company expected to finally win approval and launch the long-acting treatment next year. Now, however, the agency has made clear that it wants more pediatric data on the drug before reconsidering its merits, a revelation that will indefinitely put off Shire's plans, the company said.

What becomes of SHP 465's path to market remains to be spelled out, and Shire said it's still "engaging with the FDA to define the clinical data requirements."

Shire first filed the drug in 2006, back when it was called SPD465, in hopes of extending its reign in the ADHD market. Through the pill's years of regulatory setbacks, Adderall and its 12-hour-lasting XR offshoot have lost patent protection, but Shire has remained optimistic that its 16-hour formulation would find a place in the market.

Back in May, Shire said it expected to launch SHP 465 in first half of 2015, predicting the drug would increase its share of the U.S. ADHD market by 3% to 5%. The treatment's commercialization was one of three major catalysts Shire said would help double the size of its neuroscience business by 2020.

Meanwhile, AbbVie ($ABBV), which has signed up to absorb the Irish Shire for $55 billion, is working diligently to close its deal before U.S. regulators further crack down on such tax-saving acquisitions. AbbVie expects to wrap up the process by year's end, but new federal roadblocks have forced the company to rethink some of its financing plans.

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