Amicus Therapeutics Inc. (FOLD:US) fell to its lowest price in almost 19 months after the company said it will delay seeking U.S. approval of its experimental treatment for Fabry disease until the second half of 2014 at the earliest.
Amicus declined (FOLD:US) 23 percent to $2.47 at 12:50 p.m. New York time after earlier dropping to $2.30, the lowest intraday price since Nov. 28, 2011.
Amicus and its partner on the drug, GlaxoSmithKline Plc (GSK), may need to wait for an additional year of study beyond the current 12-month plan to ensure Food and Drug Administration approval, the Cranbury, New Jersey-based company said today. Early results from a clinical trial reported in December showed Amigal, also known as migalastat, performed no better statistically than a placebo and the FDA refused to amend its plan for the failed study, prompting the filing postponement.
“The FDA has been incredibly helpful and transparent,” Amicus Chairman and Chief Executive Officer John F. Crowley told investors today on a conference call. “They clearly recognize the unmet medical need that remains in Fabry disease and are committed to working with us to evaluate the complete data set and to determine a path toward filing an approval.”
Fabry disease is a rare genetic disorder in which patients can’t break down fats that accumulate in the body’s organs.
After six months of clinical trial Amigal showed no statistical benefit over a placebo. Forty-one percent of patients given the drug were counted as responders compared with 28 percent of the placebo group, a difference that failed to meet statistical significance under FDA guides.
The company plans to wait for another Phase 3 study -- an 18-month switch therapy trial -- to culminate in the middle of 2014 before filing for FDA approval, Crowley said. London-based Glaxo is funding 60 percent of the costs for the continuing testing programs.
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