it can be absorbed rapidly into the bloodstream in high concentrations, and it lasts long enough to support once-daily dosing. Based on the finding, the company plans to start a mid-stage study among alcohol-dependent patients in the second half of this year, Broecker says.
The second drug we talked about, called ALKS 36, is designed to hit opioid receptors for pain relief. Some of the best-known drugs in this class, Oxycontin and Percocet, are known for the side effect of causing constipation. (In fact, the constipation is a big enough deal that Progenics Pharmaceuticals developed a drug solely for relieving opioid-induced constipation, methylnaltrexone (Relistor).
ALKS 36 is a drug in two parts. The first is an opioid pain reliever that crosses the blood-brain barrier. The second component blocks opioid receptors in the intestines, and is intended to keep patients from getting constipated. This drug should be on track for its first clinical trial by the end of this year, Broecker says.
The company still has a long way to go through development, and since that’s traditionally been the role of its partners, I wondered who’s going to do the work. Even though Alkermes has built up more internal R&D capability with veterans from Big Pharma companies—including chief medical officer Elliot Ehrich, formerly of Merck—much of the work will be done by outside contractors, Broecker says. This compound also has competition from a San Carlos, CA-based drugmaker, Nektar Therapeutics (NASDAQ: [[ticker:NKTR]]).
The company’s isn’t banking on any of these new drugs to really pay the bills, not yet anyway. Alkermes is forecasting earnings per share of $2 to $3 in 2013, without factoring in any help from the new drugs coming down the pipeline, Broecker says. But he says he’s confident to place these bets, because they are based on biology that’s been well-established by other drugs, yet following the Alkermes playbook of making improved compounds. He makes it sound like Alkermes is hungry for a little more risk/reward in its portfolio, but he’s not completely throwing caution to the wind either.
“We want to leverage what’s known and make it dramatically better,” Broecker says.
