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Alkermes' ARISTADA Shows Better Results to Treat Schizophrenia

Zacks Equity Research

Alkermes plc ALKS announced positive top-line results from a phase IV study of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. The study showed that patients who switched to ARISTADA 441 mg, 662 mg or 882 mg monthly, or 882 mg every six weeks experienced statistically significant and clinically meaningful improvement in schizophrenia symptoms at the end of six months compared with inadequate response or intolerance when they were on Johnson & Johnson’s JNJ Invega Sustenna.

Further, the data from the evaluation demonstrated the differentiated efficacy and safety profile of Aristada in the treatment of schizophrenia which has a significant unmet medical need. Additionally, it highlights the unique attributes of Aristada which has a strong efficacy and safety profile, along with an unmatched range of doses and duration.

We note that the drug is an injectable atypical antipsychotic with one-month, six-week and two-month dosing options for the treatment of schizophrenia.  The drug provides a number of options to help clinicians tailor treatment to the individual needs of their patients.  The drug was originally approved in Oct 2015.

In the second quarter of 2017, Aristada sales came in at $22.7 million, up compared with $10.3 million in the second quarter of 2016. Aristada is growing impressively in a long-acting injectable (LAI) market, evident from its improvement in the double digits.

However, Alkermes’ shares have underperformed the industry year to date. The stock has declined 6.5%, as against the industry’s gain of 15.6% in the same time frame.

The company is also evaluating another candidate ALKS 3831 in phase III for the treatment of schizophrenia. In June 2017, the company announced positive preliminary top-line results from a phase III study, ENLIGHTEN-1 evaluating the antipsychotic properties of ALKS 3831 versus placebo. Efficacy study is anticipated in 2017. The company also expects to results from ENLIGHTEN -2 the pivotal six month phase III study evaluating weight in patients with stable schizophrenia receiving olanzapine or ALKS 3831 in 2018.

Alkermes PLC Price

Alkermes PLC Price | Alkermes PLC Quote

Zacks Rank & Stocks to Consider

Alkermes currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. ALXN and Regeneron Pharmaceuticals, Inc. REGN sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.32 to $5.60 for 2017 and from $6.56 to $7.05 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 17.4% year to date.

Regeneron’s earnings per share estimates have increased from $12.84 to $14.99 for 2017 and from $15.32 to $16.64 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 18.4% year to date.

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