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 in a liquid form that doesn’t require mixing and shaking, Pops says. Importantly, the cost of raw materials and manufacturing will be far lower, Pops says, and the process will be simple enough that Alkermes can hire contract manufacturers to do it on an outsourced basis. The LinkeRx platform also can be used to enhance a much broader range of small molecule drugs than the existing method, Pops says, because it doesn’t require the original drug to be nearly as potent.
Like any pharmaceutical, it’s going to take Alkermes a long time to prove all those claims. The lead drug candidate using this new technology, called ALKS 9070, isn’t expected to enter clinical trials until the second half of 2010.
But if Alkermes can successfully develop the drug, it could be a gold mine for the treatment of schizophrenia, like the long-lasting version of risperidone.
That’s because patients with schizophrenia take a quick-acting shot in the hospital, or a once-daily pill of aripiprazole. It’s a proven blockbuster medication, and the patent protection for the product is expected to last until 2015. As with risperidone, Alkermes’ belief is that a longer-lasting and stable formulation is more likely to keep patients in compliance with their dosing schedules, and help them avoid mental health relapses.
Alkermes plans to use the new chemistry approach on a number of other drugs for central nervous system disorders, including schizophrenia, depression, and epilepsy. Some of the molecules the company develops will be 100 percent owned by Alkermes, while it will seek out partners to co-develop the technology for some other treatments, Pops says.
This unveiling of the LinkeRx technology is part of what Pops was talking about when he made some vague promises in September when he took the CEO job. “You’ll see more energy around building our proprietary platform and doing business deals, and action around building the company,” Pops said at that time.
What he meant is that Alkermes was moving fast to broaden its intellectual property claims around LinkeRx, develop more molecules, and speed things up, he says now.
For what it’s worth, I had to ask Pops a little about the changing communications landscape yesterday. Last month, he joined Twitter, making him one of the very few public-company biotech CEOs—if not the only one—to do that. He didn’t broadcast the LinkeRx news on Twitter, since publicly traded companies have certain legal protocols they have to follow for communicating potentially market-moving news events like this.
I asked him if he had to defy the company’s lawyers to go out on Twitter. “They’re very jumpy about the whole thing,” he says. It’s really an experiment to see what happens, and gives him an opportunity to comment on industry news, or whatever else he wants to say—that won’t get him in legal trouble. “It’s fascinating to see the amount of attention it’s been getting,” he says.
Alkermes will have an opportunity to explain in more detail what the LinkeRx technology is about later today. The company is releasing its year-end financial report, and plans to host a conference call with analysts at 4:30 pm Eastern time.
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