Commercial launch of Aristada underway following FDA Approval for the treatment of Schizophrenia on 5 October 5, 2015
Alkermes has reported revenues for Q3 2015 of US$152.7m compared with $160.0m for the same period in the prior year, or $143.2m excluding $16.8m of revenues from the products associated with the Gainesville manufacturing facility that was divested in April 2015. Net loss according to generally accepted accounting principles in the US (GAAP) was $81.0m, compared with $40.0m for a year ago, excluding $5.5m of GAAP net income related to the Gainesville facility and associated products.
'Earlier this month, the FDA approved Aristada as the first long-acting atypical antipsychotic for the treatment of schizophrenia with both once-monthly and six-week dosing. Our nationwide commercial launch is underway and we are delighted to bring this important new treatment option to patients and the treatment community,' said Richard Pops, Chief Executive Officer of Alkermes.
'Alkermes has a number of important milestones ahead that will drive the growth of the company. Based on our recent discussions with the FDA, we have determined the design of the pivotal programmes for both ALKS 3831 in schizophrenia and ALKS 8700 in multiple sclerosis and expect to initiate both before year-end. The pivotal program for ALKS 5461 in major depressive disorder is advancing rapidly, and we expect data from the first core efficacy study in the first quarter of 2016.'
'We are pleased by our solid financial performance during the third quarter and are on track with our financial expectations for the remainder of 2015. The approval of Aristada further strengthens our commercial portfolio and represents a major financial opportunity for Alkermes,' added Chief Financial Officer James Frates. 'Heading into 2016, we are well-positioned to invest in our development plans for our late-stage pipeline, the launch of Aristada and drive the growth of Vivitrol.'