Alkermes Testing Schizophrenia Drug ALKS 9070 injectable version of Abilify

Alkermes announced plans Thursday to begin human testing of a proprietary, once-a-month injectable version of aripiprazole, a top-selling treatment for schizophrenia sold under the Abilify brand name by Bristol-Myer Squibb.

The project to develop a new, long-acting form of Abilify is being done without the cooperation or consent of Bristol-Myers. This is not a partnership between the two companies. Instead, Alkermes is striking out alone, operating under the assumption that its new drug, which it dubs ALKS 9070, will be ready for approval and launch after Abilify's patents begin to expire in 2012.

Alkermes is developing ALKS 9070 using a new long-acting drug delivery technology that the company calls LinkeRx. Drugs created using LinkeRx are designed to be easier to manufacture and more convenient to use than existing long-acting drugs, including those already marketed by Alkermes using older drug delivery systems, says Alkermes CEO Richard Pops, in an interview.

"LinkeRx is a new drug delivery platform that we can use to create new, long-acting drugs that leverage the established efficacy and safety of existing Big Pharma products," he says.

While pills are generally considered more convenient than injectable drugs, that's not necessarily the case in the schizophrenia treatment market, where long-acting injectable drugs have performed very well commercially. Schizophrenia patients sometimes resist taking their medication, so injections can increase compliance and improve outcomes.

In some respect, Alkermes' decision to develop ALKS 9070 could be seen as a defensive move to protect its revenue base in case Sustena Invega cuts into sales of Risperdal Consta.

Alkermes is completing preclinical work on ALKS 9070 and expects to begin the first human trial in the second half of the year. This study will determine whether the blood levels of ALKS 9070 given once a month are similar to those of Abilify dosed every day. Depending on the outcome of this study, Alkermes will either conduct additional dosing studies of ALKS 9070 or move directly into a phase III study, says Pops.

While ALKS 9070 is considered a new drug, Alkermes hopes to expedite its development and eventual approval by relying, to some degree, on the efficacy and safety data of Abilify. Alkermes has filed U.S. patent applications seeking to protect the LineRx technology and ALKS 9070.

 

Any updates on when this drug will be getting into and/or through Phase III? Any idea on commercial potential or launch?

 

Approval probably next Tuesday afternoon. Launch date will be the second Wednesday in June, 2016

 

I don't think the drug mentioned above (ALKS 9070) ever got approved. No one is using it and I never see anyone promoting it. Could someone on this board tell me what happened to ALKS 9070? Why did it not get approved? Our doctors love the Abilify Maintena but it wears off before 30 days from what I see. Wish you guys would have gotten yours approved. What happened? Did it fail in efficacy or were the side effects bad?

 

Already this bored?

 

The drug was approved and launched 4.5 years ago. It's called Aristada.

 

I did some research on Aristada. It looks like it is a pretty good drug. Are you guys going to be hiring a sales team to promote it. I'm currently a rep in the antipsychotic space selling a second generation antipsychotic medication. I'd love to promote your Aristada if you are going to have a sales team promoting it at some point. Is there any indication if you will be doing that? If so, when or what time frame? Serious reply only, please.

 

Bite me