Alkermes Talks ALKS 9070
Yesterday I sat down with Alkermes CEO Richard Pops to learn about the science behind ALKS 9070, the first drug to come out of its LinkeRx drug delivery technology. ALKS9070 is a long-acting version of aripiprazole, the active ingredient in Bristol-Myers Squibb’s anti-psychotic Abilify.
Alkermes already has a wealth of experience designing a long-acting antipsychotic through its work developing Risperdal Consta. But instead of using the same microsphere technology used to deliver Risperdal over time, Alkermes challenged itself to make a “virtual” microsphere, Pops says. The goal was to make a prodrug by finding a linkage site on aripiprazole that could accommodate a fatty acid tail. The drug could then be injected into the muscle, where it would stay.
For chemists working on prodrugs, the approach likely sounds, well, backwards. Normally, scientists work hard to take a molecule with poor bioavailability, and design a prodrug that can be swallowed and then metabolized (often in the gut) into the active drug. In the case of ALKS 9070, Alkermes was taking a pill and turning it into a prodrug that would be injected. The good news is, the strategy means “there’s some open space from an IP point of view,” Pops says.
The company has yet to unveil details of the linker chemistry behind its prodrug of aripiprazole, but so far it appears to work in animal models, where a once-monthly injection has proven feasible.
The beauty of the compound, Pops adds, is that the efficacy of the anti-psychotic is already established. “We don’t have to ask if aripiprazole works,” he adds. “The first clinical trial we do is meaningful." If patients injected with ALKS 9070 show the appropriate concentrations of the prodrug and Abilify in the right places, the company should be able to move right into Phase III trials. Pops adds that the company is so committed to the approach that a backup compound is waiting in the wings.
Alkermes started a Phase I trial of ALKS 9070 in November, and expected to see results from the study in the first half of this year. If commercialized, ALKS 9070 would enter an enormous market: Abilify brought in $2.6 billion in sales in 2009. And if the success of Risperdal Consta is any indication--the long-acting version represented nearly two-thirds of sales of the Risperdal franchise in 2009--the potential for market penetration is high. Stay tuned for those Phase I results.