Alkermes says its researchers nailed down the efficacy and safety data it needed from an early-stage study of ALKS 8700, its new-and-improved rival to the blockbuster multiple sclerosis drug Tecfidera from Biogen Idec ($BIIB). And now the transatlantic biotech plans to shift its drug straight into a pivotal study in search of a relatively swift approval.
The key here was finding that the oral 8700, a monomethyl fumarate, didn't trigger the same gastrointestinal issues as the dimethyl fumarate Tecfidera, a drug that has been expected to break the $5 billion mark in peak sales.
Alkermes reports that the "percentage of subjects with GI-related (adverse events) was lower with ALKS 8700 (8.3%) compared to Tecfidera (41.7%)." The GI side effects are a well known problem in the medical field, preventing a minority of patients from continuing treatment. Its impact is particularly harsh in the first weeks of treatment.
Alkermes shares were down this morning, though, slipping about 4%.
Alkermes considers 8700 one of its top drug prospects. While most high-profile drug developers are looking to advance new chemical entities with greater efficacy for diseases, Alkermes chief Richard Pops has pursued a different strategy: Working on drugs that can be as or more effective than leading blockbusters but without the side effects that can roil patients' lives. It's not particularly sexy, but Alkermes' market cap--now nearing $10 billion--has swelled during the biotech boom with derisked drugs for schizophrenia (taking out the risk of weight gain) and more.
"The results from this study demonstrated ALKS 8700 converts efficiently into MMF after oral administration with the potential to offer improved GI tolerability for patients with MS," said Elliot Ehrich, the CMO of Alkermes. "This highly informative clinical study provided clear data regarding dose selection and supports our decision to advance ALKS 8700 twice-daily into pivotal development later this year. In addition, it provided new insights into approaches for once-daily dosing options, which we will continue to pursue."
- here's the release