Merck delaying odanacatib submissions

Merck & Co. Inc. (NYSE:MRK) disclosed in its 4Q12 and 2012 earnings that it will delay to 2014 from 1H13 the expected submission of regulatory applications in the U.S., EU and Japan for odanacatib to treat osteoporosis. The pharma said the delay is a result of its decision to include data from about 8,200 women in a double-blind extension of a Phase III trial for the cathepsin K inhibitor. Last July, Merck said it would close the trial after the study's DMC recommended stopping the trial early due to the "robust" efficacy in reducing fracture risk and a favorable benefit-risk profile of the compound. However, at the time the pharma noted that the DMC said "safety issues remain in certain selected areas" and recommended that Merck continue the double-blind extension of the trial to monitor the undisclosed issues. Merck declined to provide details (see BioCentury Extra, July 11, 2012).

Merck also disclosed that it submitted a BLA to FDA in January for its Grass Allergy Immunotherapy Tablet (AIT). Merck has exclusive North American rights to the product from ALK-Abello A/S (CSE:ALK-B), which markets it as Grazax in Europe. ...