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Alkermes Reports New Developments On Late-stage Central Nervous System Pipeline

Alkermes plc (ALKS) announced new developments related to its late-stage product candidates in its proprietary central nervous system or CNS pipeline.

The company unveiled aripiprazole lauroxil two-month, a new product candidate addition to its portfolio of atypical antipsychotics for the treatment of schizophrenia. If approved, aripiprazole lauroxil two-month would be the first and only long-acting atypical antipsychotic medication dosed every two months. This new two-month product candidate is designed to provide physicians and patients with an even longer dosing option than the once-monthly formulation of aripiprazole lauroxil, which is currently completing the phase 3 study, with topline results expected in the first half of 2014.

The aripiprazole lauroxil two-month product candidate is designed to offer physicians and patients a dosing option that is not currently available, and Alkermes plans to begin clinical testing in 2014. Both the one-month and two-month forms of aripiprazole lauroxil are long-acting injectable medications that, once in the body, convert into aripiprazole, a molecule that is commercially available under the name ABILIFY, and both utilize the company's proprietary LinkeRx technology.

In addition, Alkermes announced details regarding the pivotal program and innovative phase 3 clinical trial design for ALKS 5461, a proprietary drug candidate with a novel mechanism for the treatment of major depressive disorder or MDD. The pivotal program is expected to begin in the first quarter of 2014.

The pivotal clinical program will include three core phase 3 efficacy studies and is expected to enroll a total of approximately 1,500 patients with MDD who have had an inadequate response to standard therapies. The three core efficacy studies will utilize sequential parallel comparison design (SPCD) to reduce the impact of clinically meaningful placebo response. The primary efficacy endpoint for all phase 3 studies will be the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline.

The pivotal program will also evaluate remission as a secondary endpoint, following the recently reported remission data from the phase 2 study of ALKS 5461, in which 35-50% of patients in the study achieved remission, as evaluated by MADRS scores, across the two stages of the study. In addition to the three core efficacy studies, the pivotal program will also include studies to evaluate the long-term safety, pharmacokinetic profile, titration schedule and human abuse liability of ALKS 5461. The first study to commence in the ALKS 5461 pivotal program will be a study to evaluate onset of clinical effect, safety and tolerability.

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