Summary
Fingolimod must be doing something right, because the latest study shows significant reduction in disability progression and relapse rates, even at the small doses tested (0.5 mg/d). Novartis is poised to submit an IND at the end of 2009 (very soon). The results of the FREEDOMS trial suggest that fingolimod is very effective in addressing the common indicators of therapeutic efficacy. Long-term studies will be required to further explore potential side effects and to document the extent of long-term benefit.
Analysis
There are three ways in which the news regarding fingolimod will be used to shake up the MS research community.
- First, there is a "race" under way to gain priority as the first oral agent for treating relapsing forms of mutliple sclerosis. The winner of this race will gain substantial market leadership, simply by being the first to offer an oral product. The FREEDOMS press release demonstrates that Novartis is in the game, and likely to "win, place or show" in this race.
- Second, the FREEDOMS press release reports on high levels of therapeutic benefit for even the lowest tested doses of FTY720 (fingolimod). This will draw attention to the underlying disease mechanisms implicated by fingolimod's success. A flurry of drug development activity is likely to result in order to exploit the potential mechanisms implicated by fingolimod's apparent success in treating relapsing forms of multiple sclerosis.
- Third, the availability of oral therapies for MS seems more likely, based on the success of the FREEDOMS trial. Thus, the traditional injectable immunomodulatory therapies (i.e., the beta-interferons and copaxone), natalizumab, and mitoxantrone are likely to see a decrease in new starts and conversions, or at least slower growth. I draw this conclusion based on very simple clinical principles:
a. If a patient/physician thinks an oral agent with efficacy similar to (or superior to) existing injectables (ABCRTN) is coming, then why would they bother to make a start injecting themselves, or switch from one injectable to another. I think the more informed patients and physicians will "sit tight" awhile, and see what happens with the FDA approval process, hoping they can use the oral drug soon.
b. Some people who have decided against disease modifying therapy (DMT) because they just didn't consider themselves "sick enough" to start injecting themselves will now come "out of the woodwork." Just as the clinically isolated syndrome issue led to more new starts, the availability of an oral therapy will make MS seem more feasible to treat in the earlier, milder stages, when the symptoms and signs may be so mild that a patient wouldn't ever consider giving themselves shots. Even though fingolimod has not been tested for CIS, to my knowledge, the simple availability of an oral agent will lead CIS patients and others with milder forms of relapsing MS to seek medical attention and consider treatment they otherwise might have shunned.
c. Novartis is now in the MS marketing business. By developing the marketing workforce necessary to promote its beta-interferon, Novartis has begun the process of putting the people in place to promote fingolimod (or its other MS products). Without such a marketing workforce, its competitors might not view Novartis as much of a threat. Now, however, they realize that Novartis is investing in the resources to carry its pipeline right into doctor's offices.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
