Amicus & GlaxoSmithKline Report Study 011 Results, Sanofi Settles with DOJ: Healthcare Biz Update

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On Wednesday, Amicus Therapeutics (NASDAQ:FOLD) and GlaxoSmithKline (NYSE:GSK) reported the 6-month primary treatment period results from the first Phase 3 global registration study (Study 011) of investigational oral migalastat HCl monotherapy in males and females suffering from Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. Study 011 randomized 67 patients to receive oral migalastat HCl 150 mg or placebo on an every-other-day dosing schedule during a 6-month, double-blind primary treatment period.

Endo Health Solutions (NASDAQ:ENDP) said Wednesday that United States District Judge Reggie B. Walton, of the United States District Court for the District of Columbia, threw out the case of its subsidiary, Endo Pharmaceuticals, against the FDA.  The latter contended that the agency failed to meet its legal obligation to determine in a timely manner as to whether the original formulation of OPANA ER was pulled from the market for safety reasons, but the judge decided against Endo, commenting that he believes the FDA did not unduly delayed making a determination on the matter. The FDA responded that it expects to make its determination by May.

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Subsidiaries of the international drug manufacturer Sanofi-Aventis (NYSE:SNY) will pay $109 million to settle allegations that the company violated the False Claims Act by supplying physicians with free units of Hyalgan, in violation of the Anti-Kickback Statute, through which to induce them to buy and prescribe the product. Additionally, the resolution clears ups claims that Sanofi submitted incorrect average sales price reports for Hyalgan which did not account for free units distributed, contingent on Hyalgan purchases. The Justice Department says that the false price reports, which were used to set reimbursement rates, caused government programs to pay inflated amounts for Hyalgan and a rival product.

Team Health Holdings (NYSE:TMH) announced Wednesday the pricing of the previously announced secondary offering of 8 million shares of its common stock to be sold by its principal stockholder, Ensemble Parent, through a registration statement that the former previously filed with the Securities and Exchange Commission, to the public at $28.95 per share. Ensemble Parent has granted the sole bookrunner an option to buy as many as 1,.2 million additional shares of common stock. The firm will not receive any proceeds from the sale of shares.

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