Alkermes plc (NASDAQ: ALKS) is a biopharmaceutical company that focuses on central nervous system diseases. The company has a major catalyst approaching, as the U.S. Food and Drug Administration (FDA) scheduled a Prescription Drug User Fee Act (PDUFA) for aripiprazole lauroxil, with target action date for August 22, 2015. Aripiprazole lauroxil is one of the company’s main product candidates, and it is a novel, once a month injection treatment of schizophrenia.
The FDA's decision will be based on the evaluation of positive results from the pivotal phase 3 trial assessing the efficacy and safety of aripiprazole lauroxil. The trial showed significant improvements in schizophrenia symptoms, compared to patients who were on placebo.
Alkermes has a diverse pipeline of emerging products. Besides schizophrenia the company works on new medicines designed significant progress in treatment of chronic central nervous system conditions that affect millions of patients worldwide such as major depressive disorder and multiple sclerosis.
Chief Executive Officer of Alkermes, Richard Pops, said in a statement, “The FDA acceptance of the aripiprazole lauroxil NDA marks the achievement of an important milestone for this program and brings us another step closer to offering patients and physicians a new treatment option for schizophrenia with distinctive features, including a range of doses and ready-to-use format,” stated. “If approved, aripiprazole lauroxil could be a significant new entrant in the increasingly important category of long-acting injectable medicines for schizophrenia.”
Alkermes has reported debt of $356 million and cash $747 million. The company has raised debt back in 2012, and with a $15 million cash spent on operating activities in the recent quarter there is no short term risk of dilution.