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FTY720 is seen by some as being the 'gold standard' for MS treatment in the future. Unfortunately, approval unlikely until 2010.

In recognition of my sterling efforts this week Arron has kindly offered me two free weeks at his villa in California. Many thanks Arron I'll keep the good work up.

Ian



Novartis: FTY720 offers gold standard MS potential 16 March 2006

Novartis drug to become preferred front-line agent for the treatment of multiple sclerosis.

Phase II trial results have already highlighted the potential of Novartis' oral multiple sclerosis drug FTY720. Assuming that phase III results confirm this efficacy data, the drug candidate has the potential to dominate the MS market over the longer-term.

Multiple sclerosis (MS) is characterised by significant unmet need, with no cure currently available. Treatments are used to modify the disease's course, treat exacerbations, and manage symptoms. However, most patients still suffer from some attacks and subsequent disability. Furthermore, the efficacy of currently approved MS agents tends to diminish over time and the American Academy of Neurology (AAN) estimates that 35-50% of MS patients do not have an optimal response and, therefore, may benefit from alternative therapies.

Novartis' FTY720 was highlighted for particular attention after the once-daily, oral agent demonstrated a 55% reduction in relapse rates and an 80% reduction in lesions compared to placebo after six months.

The potential market opportunity awaiting new MS agents has increased following the market withdrawal of Tysabri. Although the FDA recently ruled that Biogen Idec and Elan can resume sales of Tysabri, questions still surround the drug and its future role in the treatment of MS.

FTY720 also stands to gain as a result of its delivery method. With a superior administration profile compared to currently injectable MS agents, it is expected that oral pipeline agents to gain significant market share upon their approval. Use of beta-interferon agents for the treatment of relapsing-remitting MS (RRMS) will decline sharply upon the approval of oral MS formulations, with oral MS agents accounting for 43% of the RRMS market by 2014.

FTY720 is the most promising of the five oral MS agents currently in the late stages of development, some of which may yet struggle with significant regulatory and development hurdles. In addition, where data is available, efficacy associated with all other oral MS agents in development have thus far been inferior compared to phase II FTY720 results.

Providing that data from the phase III trials, scheduled to start in early 2006, are comparable to those shown in phase II, FTY720 is set to become the preferred front-line agent for the treatment of RRMS post-approval in 2010.

Source: Pharmaceutical Business Review ©2006 Business Review Ltd

Is it normal for a phase III trial to take 4 years? Is this backlash from the feeling that Tysabri was rushed into approveal? If the phase II were so excedingly impressive I wish we could have it sooner atlthough 55% reduction in relapses still leaves a lot of room for improvement. I'm surprised that they think oral medications will only account for 43% of the MS market by 2014. I would think it would be much higher. Of course I'm hoping they find something to completely halt it by then anyways

Scoobyjude,

2010 does seem a long way off but if the Phase III only started this year then four years is probably right - and given what's happened on a trial in the UK this week, there's bound to be stricter controls etc.

Of course, there are some trials of drugs such as Rituximab, which are already approved for other diseases. I imagine that if this drug shows effect on those with PPMS (where there is no approved treatments) it might be fast-tracked.

One would hope that by 2010 there would be some neuro-protective therapies available and some headway in promoting remyelination and repair of nerve fibres. What we may see is combo treatments where you take something like FTY720 to dampen down the damage caused by the immune system, something which protects the nerve fibres which have been exposed (neuro-protective drugs and/or promoting remyelination), and something which promotes nerve fibres to regrow. In Dignan's list, there is a French drug which is combining molecules to address inflammation and be neuro-protective.

To add more confusion, by 2010, they should know which genes are involved and may be able to tackle it this way.

I spoke to an old schoolfriend recently and we were talking about the computers we had in the mid-1980 (Sinclair ZX-81). It's unbelievable how fast technology has changed (even year on year), and it will be technology that drives the breakthroughs with this disease. By 2014 we may not need FTY720 at all and you have to feel sorry for Novartis (but I won't feel that sorry).

Ian

HECK NO, I WON'T FEEL TOO SORRY EITHER. I HOPE TO BE DANCING IN THE STREETS MS-FREE BY 2014. (WE CAN ALWAYS HOPE ) YOU'RE RIGHT ABOUT TECHNOLOGY. IT AMAZES ME THE THINGS THEY CAN COME UP WITH AND IMPROVE.
I THINK IT WOULD BE GREAT IF THEY COULD COMBINE TREATMENTS FOR DIFFERENT ASPECTS OF THIS DISEASE. IF THEY COULD FIND A CONSISTENT WAY OF REMYELINATING AND NEURO PROTECTING I THINK THAT IS ALMOST MORE OF A CONCERN RIGHT NOW THEN COMPLETELY STOPPING RELAPSES. WE NEED A WAY TO HEAL THE DAMAGE THAT HAS BEEN DONE AND PREVENT MORE BEFORE IT IS TOO LATE. DON'T GET ME WRONG, IF THEY COULD FIND A CURE THAT WOULD BE EXTRAORDINARY BUT I THINK REPAIRING DAMAGE IS MORE REALISTIC RIGHT NOW. I DO HAVE A FEELING THAT BY THE TIME THAT FTY720 IS APPROVED-ITS SHIP MAY HAVE ALREADY SAILED. MAYBE NOT IF IT'S AS IMPRESSIVE AS THEY SAY. WE'LL SEE.
DO YOU HAVE ANY SPECIFIC INFO ON THE RESEARCH THAT THE MYELIN REPAIR FOUNDATION IS WORKING ON? THEY MENTION TRIALS OF 2 DRUGS BUT NOTHING MORE THAN THAT. NO NAME OR STATUS OF THE TRIALS. THEY CLAIM THAT BY 2009 THERE WILL BE MYELING REPAIRING TREATMENTS AND ARE PRETTY CONFIDENT OF THIS FACT. I HOPE THEY ARE NOT BEING COCKY AND ACTUALLY HAVE A REASON TO BE SO SURE OF THEMSELVES. IF NOT, I'M SURE SOMEONE WILL BE ABLE TO FIGURE IT OUT SINCE IT SEEMS TO BE WHERE A LOT OF RESEARCH HAS NOW BEEN FOCUSED. GUESS WE'LL JUST HAVE TO BE PATIENT. (BY THE WAY, NOT MY STRONG POINT)

Is there any data on reducing progression to disability? I think everyone is coming to accept that reduction of lesion load and relapse rate do not necessarily indicate a reductino in the overall progression of the disease. If this is to be the new standard of MS treatments, they should use the new standard for measuring treatment efficacy.