Alkermes beefs up pipeline, putting a new twist on blockbusters

Richard Pops--Courtesy of Alkermes

Alkermes built its reputation around drug delivery and formulation technology, contributing its know-how to develop new-and-improved therapeutics. Now it wants to use that knowledge to whip up a new slate of next-gen therapeutics that can outperform some blockbuster drugs on the market for chronic diseases.

That's the theme Alkermes ($ALKS) CEO Richard Pops is striking during today's R&D day presentation, which includes the news that the biotech company is doubling its pipeline with three new, early-stage therapies. Alkermes is also launching its midstage study of an antipsychotic--ALKS 3831--a broad-spectrum therapy combining a new opioid modulator, ALKS 33, and Zyprexa, shooting for a new-and-improved approach to schizophrenia without the threat of sudden weight gain.

The beefed-up pipeline reflects Alkermes' focus on drugs "where we know pharmacology can be improved," Pops tells FierceBiotech.

The three new drugs about to enter the clinic are:

  • A reformulated MMF prodrug successor to Tecfidera (BG-12), Biogen Idec's ($BIIB) big, twice-daily entry for multiple sclerosis.
  • A pain drug dubbed ALKS 7106, using some new tech to make it more abuse-proof, a key theme in that field after Oxycontin.
  • And RDB 1419, a new IL-2 immunotherapy cancer drug that is designed to realize the early promise of that field by improving on the selectivity for IL-2 receptors while "engineering down the deleterious effects of IL-2."

The company has been hammering out a countercyclical R&D strategy, says Pops. Pharma's been moving away from the big chronic diseases to go after orphan and ultra-orphan indications. So Alkermes is tackling the chronic disease market, but doing it in biotech fashion--targeting specific patient segments that will do better on these new-and-improved therapeutics.

"We think Tecfidera is an impressive drug," notes Pops. But it also has some serious side effects. "There are ways to think about improving this drug for people who are going to take this drug for a very, very long time." And there's also a way of doing it with once-a-day dosing, which would help keep patients on track with their dosing schedule.

The biotech is tackling Zyprexa by targeting a new drug that avoids weight gain while making it suitable for patients with a dual diagnosis for substance abuse. In many cases, that dual diagnosis is for alcohol abuse, and investigators have already seen a "big reduction in drinking" when it was tested in humans, which could open the door to a large new market for their therapy.

Unusually, Alkermes is doing a head-to-head comparison of its combo treatment with Zyprexa in Phase II. "We're asking the critical question early," says Pops. That trial is expected to run through 2014, with data in 2015. And Alkermes expects to get aggressive on all of its programs, looking for early-stage proof-of-concept data as they map the shortest path possible for an approval.

Alkermes already has late-stage programs in the pipeline. It also recently reported promising mid-stage results for ALKS 5461, a new drug for depression. Adding several more early-stage drugs may not look like a lot compared to any company on the Big Pharma side of the spectrum, but it will fashion the future for this international company.

- here's the release on the new pipeline candidates
- see the release on the ALKS 3831 study

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