EMA recommends expanded indication for Ozurdex The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Ozurdex from Allergan Pharmaceuticals Ireland. The CHMP adopted a new indication as follows: "Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular edema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy."
Actavis completes acquisition of Allergan Actavis plc (ACT) announced that it has completed the acquisition of Allergan (AGN) in a cash and equity transaction valued at approximately $70.5B. The combination creates one of the world’s top 10 pharmaceutical companies by sales revenue, with combined annual pro forma revenues of more than $23B anticipated in 2015. Actavis continues to expect the transaction to generate double-digit accretion to non-GAAP earnings within the first 12 months, including approximately $1.8B in operating and financial synergies to be realized within one year following the close. These synergies exclude any additional revenue or manufacturing synergies, and are in addition to the $475M of annual savings previously announced by Allergan in connection with Project Endurance. Actavis further expects to generate strong operating cash flow in excess of $8B in 2016, which would enable the company to rapidly de-lever the balance sheet.