Alkermes’ (ALKS) pipeline has broadened significantly following its acquisition of the erstwhile Elan’s drug delivery unit in 2011. Elan was subsequently acquired by Perrigo Company (PRGO) late last year. Interesting candidates at Alkermes include aripiprazole lauroxil, ALKS 3831 (schizophrenia) and ALKS 5461 (major depressive disorder).
Alkermes is working actively to develop its pipeline. In fact, the company has reported several pipeline related news so far this year. We also expect quite a few pipeline related updates in the remainder of the year.
Earlier this week Alkermes announced the commencement of a 15-month phase II trial (n~450) on ALKS 3831. ALKS 3831 is a combination of samidorphan (formerly ALKS 33) and Eli Lilly and Company’s (LLY) antipsychotic drug Zyprexa (olanzapine).
Alkermes intends to evaluate the efficacy, safety and tolerability of the candidate in patients suffering from schizophrenia versus Zyprexa in this study. The patients also have an alcohol use disorder. The goal of the randomized, double-blind, active-controlled study is to compare the exacerbation of symptoms due to alcohol use disorder in schizophrenia patients across the two cohorts. Top-line results from the study should be out in mid 2017.
Alkermes stated in its press release that more than 33% of schizophrenia patients also suffer from an alcohol use disorder. However, the population is often left out from clinical trials and is widely undertreated.
We note that this study is the second part of a phase II program on ALKS 3831. The first phase of the program has been underway since Jul 2013. The first phase is evaluating the attenuation of weight gain associated with Zyprexa in schizophrenia patients.
ALKS 3831 had performed encouragingly in phase I. Results from the study, unveiled in May 2013, showed that weight gain in patients who were administered ALKS 3831 for three weeks was significantly lower (an average of 2.5 kg) than in patients who took Zyprexa (an average of 3.4 kg).
The company stated in its press release that weight gain is a common side effect in atypical antipsychotic medications with Zyprexa being associated with the highest occurrence as well as magnitude of weight gain in this class of drugs.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) is a better-ranked stock, sporting a Zacks Rank #1 (Strong Buy).