Alkermes is known for making drugs stable and long-lasting in the bloodstream. Today, the Waltham, MA-based company is announcing it has invented a new way to do the same thing, but at lower cost and with fewer manufacturing hassles. There’s also the potential that the new technique could be used on more drugs, and lead to greater convenience for patients.
The company (NASDAQ: ALKS) is announcing today that it has invented a new platform, and filed a raft of patent applications, around what it calls LinkeRx technology. Alkermes intends to prove the value of this idea first with a modified version of aripiprazole, a $2 billion-a-year antipsychotic medication marketed by Bristol-Myers Squibb as Abilify. I got the rundown on what’s different about the new technology, and the business strategy behind it, during a conversation yesterday with CEO Richard Pops.
For those new to the story, Alkermes has built its company around the idea of taking existing drugs and packaging them in biodegradable polymer microspheres that last longer in the blood. This allows patients to take fewer injections, and avoid peaks and valleys of drug concentration in the blood that can come from once-daily therapies. The Alkermes technology is currently used in Johnson & Johnson’s risperidone (Risperdal Consta), a $1.4 billion annual seller, which helps schizophrenia patients stay on the meds they need, Pops says. Alkermes is also providing critical enabling technology for exenatide once-weekly, a diabetes treatment that San Diego-based Amylin Pharmaceuticals and Eli Lilly are trying to get approved by the FDA.
While the microsphere technology represents Alkermes’ past and present, the new technology will be a big part of the future, Pops says.
“This is actually a big advance,” Pops says. “It’s been a glimmer in our eye for the last several years.”
This requires a little bit of background before diving in. Today, Alkermes uses an expensive, proprietary, sterile manufacturing process to encapsulate drugs with a biodegradable polymer in a microsphere. The polymer, when exposed to body temperatures, is designed to slowly dissolve and release the active drug. The finished product comes in a dry powder, which needs to be kept refrigerated so it doesn’t release the drug prematurely. It has to be mixed with a water-based solution, and shaken, before it can be injected into the patient.
“We said, ‘Let’s get rid of the polymers and see if we can re-engineer the molecule itself,” Pops says.
So Alkermes’ chemists went to work on LinkeRx. The method uses a proprietary linker and chemical tail that’s attached to an oral drug, which creates a new molecule that’s long-lasting and injectable. The newly engineered drugs don’t need to be kept in a refrigerator, and can be distributed … Next Page »
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