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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.
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