Alkermes ($ALKS) said the safety profile of its clinical-stage multiple sclerosis drug compares favorably to that of Biogen Idec's Tecfidera, citing the candidate's Phase I trial results on 104 patients.
ALKS 8700's active ingredient (monomethyl fumarate) is different than the Biogen Idec ($BIIB) blockbuster (dimethyl fumarate)--which is predicted to top the $5 billion mark in peak sales--but so is the delivery method. It is orally administered as a prodrug, meaning the compound remains inactive until the body's enzymes metabolize it.
The candidate is squarely aimed at taking on Tecfidera, though that remains a long way off. Alkermes said the data shows the candidate "was generally well tolerated and provided MMF [monomethyl fumarate] exposures comparable to Tecfidera, with less variability and improved gastrointestinal (GI) tolerability."
Some multiple sclerosis patients in the trial were given Tecfidera. They had a higher rate of GI-related adverse events (41.7%) compared to those on ALKS 8700 (8.3%), according to the release. Thus, the candidate represents a continuation of Alkermes' strategy of designing differentiated drugs based on blockbusters, but with fewer side effects.
Equity analysts agree that if the results hold up in future trials, the prodrug is in line for a big pay day. "Meaningful improvements of diarrhea rates (e.g., 50% improvement) could lead to 25% of Tecfidera patients to switch to the alternative drug, assuming equal efficacy, potentially indicating at least a $2 billion opportunity for ALKS 8700 in a conservative scenario," wrote Leerink analyst Michael Schmidt in a research note, according to the Boston Business Journal.
Another part of Phase I was devoted to exploring an extended-release option, which would enable once-a-day dosing, but Alkermes is moving forward with a twice-a-day version of the candidate.
"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," Alkermes Chief Medical Officer Dr. Elliot Ehrich in a statement. "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."
- read the release
- here's the Boston Business Journal's take