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Saturday, October 17, 2015

FDA eye drug rebuff adds to Shire's woes in Baxalta pursuit, (NASDAQ: SHPG)

Shire Plc suffered a setback for its most important pipeline medicine late on Friday, adding to the group's problems as it pursues Baxalta Inc to forge the leading global specialist in rare diseases.The Irish company said the U.S. Food and Drug Administration (FDA) had declined to approve its new eye drug lifitegrast and had requested an additional clinical study.The news comes just over a week before the FDA was supposed to make a decision on the treatment for dry eye disease, which analysts have penciled in as a potential $1 billion-a-year-plus seller. Shire said it received a so-called complete response letter from the FDA. Such letters are sent out to let a drug developer know a marketing application will not be approved in its present form.

Shire plc is a biopharmaceutical company. The Company, along with its subsidiaries, is engaged in developing and marketing medicines for patients with rare diseases and other specialty conditions. Shares of SHPG traded higher by 1.74% or $3.58/share to $209.63. In the past year, the shares have traded as low as $180.20 and as high as $270.63. On average, 884969 shares of SHPG exchange hands on a given day and today's volume is recorded at 560468.