Competition can be a good thing, especially for the consumer. Recently, I reported that Merck submitted a request to the European Medicines Agency requesting approval for the use of oral Cladribine for the treatment of Multiple Sclerosis.
Since all the major treatment options for MS are currently injection or infusion based, a safe, effective oral medication for MS would be a breakthrough. Merck is not the only pharmaceutical company in the race to be first-to-market with an oral treatment for Multiple Sclerosis. Novartis AG is giving Merck a run for their money. They are actively pursuing approval for their own version of an oral MS medication, FTY720 (Fingolimod). Formal requests for approval are expected to be submitted later this year in both the US and Europe.
FTY720 is an “immune-modulating” drug. It works by binding to the receptor site on immune cells and then trapping them in the lymph nodes. Since the immune cells are trapped in the lymph nodes, the theory is that they are unable to go scampering about in our brains and cause the damage which results in MS symptoms. Phase III (code named TRANSFORMS) of the FTY720 trials has been completed and Novartis presented the results earlier this year at the American Academy of Neurology convention in mid-April, 2009. The results were promising with 80-83% of all patients on FTY720 relapse free! No matter how you look at it, those are quite impressive results.
During the course of the trial, participants were given one pill, administered once a day. The dosage consisted of either 0.5 mg or 1.25 mg. It was reported that the 0.5 mg worked better than 1.25 mg. During the course of the trial, Novartis specifically compared FTY720’s performance to Avonex. Avonex is currently in the number one spot in the MS medication marketplace. Novartis reported that the 1-year relapse rate was reduced by 52% in low-dose patients and 38% in high dose patients compared to Avonex. The long-term trial results were also excellent reporting as follows:
• 67% remained relapse free after three years
• 89% free of inflammatory disease activity (confirmed via MRI scans)