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New Oral Agents for Multiple Sclerosis, Including Novartis/Mitsubishi Pharma's Novel Drug, Will Capture 25% of Market Share by 2020
28 March 2007

Concerns Over Safety and Efficacy Will Prevent Emergence of a Blockbuster Drug Through 2020, According to a New Report from Decision Resources.

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that emerging oral therapies for multiple sclerosis, including a new drug from Novartis/Mitsubishi Pharma, will capture 25% of the market share by 2020 in the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.

The new Pharmacor report Multiple Sclerosis 2005-2020: Will Emerging Oral Agents Unseat Current Therapies? finds that Novartis/Mitsubishi Pharma's new agent, currently known as Fingolimod (also called FTY-720) will outperform other emerging therapies because of its oral formulation, superior efficacy, and acceptable safety profile, although experts temper their excitement with caution because the drug's side-effect profile has not yet fully emerged.

Physicians' and experts' wariness concerning drug safety was prompted by the development of serious infections (three of which proved fatal) in five patients who received Biogen Idec/Elan's Tysabri, which launched in the U.S. market in 2004. For safety concerns, Tysabri was pulled from shelves in 2005 -- following a safety review, the drug was re-approved by the Food and Drug Administration in 2006.

"The history of serious side effects associated with Tysabri has not only impaired its once-promising market potential but also negatively influenced physician opinion of emerging therapies," said Decision Resources Analyst Bethany Kiernan, Ph.D. "As a result of overarching concerns over safety and efficacy, we forecast that no emerging therapies will obtain blockbuster status through 2020."

Source: Decision Resources, Inc

Is this article saying that oral medications will not be fully available till 2020 because of safety concerns? That would stink. I hope they are exaggerating.
On a side note, I asked my neuro (who is not a research genius) when he felt an oral medication would be available and he said not sooner than 5 years. I was thinking 3 but now I have no idea.

FTY720 is not likely to be the first oral drug available. I've read/heard that an oral drug could be as little as 2 years away.

The phase 3 trial of Mylinax (oral cladribine), by Serono, completed enrollment in mid-January. It's a two year trial, add in some time to compile / submit results and time for the regulator(s) to make a decision and realistically, late 2009 is about the earliest we can hope for an oral treatment. That is, unless you want statins or antibiotics off-label...

Late 2009 sounds good. It's about what I was thinking, but will the safety concerns raised over Tysabri delay oral medications from being put on the market? Do you think they will push it past a normal trial timeframe? My neuro and this article are making me very curious. Can you tell I hate my shots?

I'm just guessing, but it seems unlikely that the regulators would approve another substance after only 1 year of data from phase 3 trials, as they did with Tysabri. However, I don't think they will delay treatments that successfully complete 2 year phase 3 trials. At least I haven't heard any suggestion that they would do so. Of course, each drug has to demonstrate efficacy and not cause any unacceptable side effects to get by the regulator still, so we shouldn't count our chickens...

It would be really sad if a drug like FTY720 wouldn't emerge in the market until 2020, especially considering that it is basically just another "band-aid" drug, not a definite fix by any means.

Brock

Hi Scooby,
It seems like they were talking about two different things in the article and didn't do a very good job of separating them.

On one hand they make the statement

Concerns Over Safety and Efficacy Will Prevent Emergence of a Blockbuster Drug Through 2020

which makes you wonder what their definition of a "blockbuster drug" is.

Then a couple of times they make the statement

emerging oral therapies for multiple sclerosis, including a new drug from Novartis/Mitsubishi Pharma, will capture 25% of the market share by 2020

which leads you to believe that oral therapies will be available at some unknown time before 2020 and for some reason we should believe that they will have only captured 25% of the market at that point.

Personally I'd have to believe that if an oral drug at least as effective as the crabs without glaring side effects became available, it would find 80-90% of the market..immediately.......or as quickly as they could pump up production to meet the demand.

Bob

Lyon wrote:

if an oral drug at least as effective as the crabs without glaring side effects became available, it would find 80-90% of the market..immediately.......or as quickly as they could pump up production to meet the demand.

Totally agree Bob. If they can produce an oral medication that has even the same effectiveness as the CRABs without major side effects-I'd jump ship in a second. I'm sure a lot of people feel the same way.
Judie

Lyon wrote: Personally I'd have to believe that if an oral drug at least as effective as the crabs without glaring side effects became available, it would find 80-90% of the market..immediately.......or as quickly as they could pump up production to meet the demand.

Hi Bob, and everybody,

The sad fact is that change does not happen that fast. Many doctors will not embrace new treatments until they become more commonplace. Remember that most neuros are regular all purpose neuros and do not necessarily keep up to date on the latest treatments for MS per se ...

If something new comes available, there will be many who lag in accepting it because of the fear of what it might bring. If there is something new, and you do your own research, you might have to go looking for a doctor, and it might mean driving a distance unless you're in a major city where the latest treatments are available.

This is the reason I drive 90 miles to see my neuro. Although I have learned that one of the local ones does have Tysabri treatments available, which was very surprising to me!

Hi Ewizabeth,

This one might be a tough call.

True, I made the false assumption that all MS patients are as aggressive as the people who visit this site and that's not nearly true. It might be said that the majority of MS patients do exactly what their neuro recommends.

On the other hand, there is going to be a ton of advertising before an oral treatment is actually released. The release of an effective oral MS treatment is going to be a huge to-do and it's hard to imagine that any neuro is going to be able to avoid hearing about it.

Unlike Tysabri which can only be administered by registered infusion centers, and a lot of neuros opted not to go to the expense and effort to become an infusion center, an oral MS drug will be available at every pharmacy and all that will be required of a neuro is to write a prescription.

I've been WAY wrong before but I'd have to believe that when an oral drug becomes available, and if it doesn't acquire a bunch of bad baggage along the way, I'd have to think that not only will most people throw their needles away but a good number of people not currently on treatment would seriously consider an oral treatment.

Bob

At this point, availability of an oral agent and the market share it'll capture is merely guesswork-- and the market analysts quoted in this article have about as much ability to predict any of it as any of us do. My neuro (an MS specialist from a major teaching hospital) is betting on FTY720 being the next big thing-- he's thinking late 2009 availability. Maybe we can all place bets with a bookie somewhere in London?

Lyon wrote: On the other hand, there is going to be a ton of advertising before an oral treatment is actually released. The release of an effective oral MS treatment is going to be a huge to-do and it's hard to imagine that any neuro is going to be able to avoid hearing about it.

Unlike Tysabri which can only be administered by registered infusion centers, and a lot of neuros opted not to go to the expense and effort to become an infusion center, an oral MS drug will be available at every pharmacy and all that will be required of a neuro is to write a prescription.

I've been WAY wrong before but I'd have to believe that when an oral drug becomes available, and if it doesn't acquire a bunch of bad baggage along the way, I'd have to think that not only will most people throw their needles away but a good number of people not currently on treatment would seriously consider an oral treatment.

Bob,

That makes a lot of sense. They WILL use the lack of needles as a marketing advantage and it will get people's attention I'm sure. It might take another trial comparing it to some of the existing therapies to get it to really gain market share though. Some people that are doing ok on the shots or infusions might be hesitant to change for awhile.

ewizabeth wrote:Some people that are doing ok on the shots or infusions might be hesitant to change for awhile.

That's a good point. Wishful thinking on my part but hopefully the orals will prove more effective than the crabs and make the decision REALLY easy
Bob

Bob, that's the key I think. If the oral meds are more effective without nasty side-effects, the adoption should be rapid. If they are equivalent to the CRABs I can just imagine a lot of neuro's saying to their patients, "If you're doing well on CRAB X, maybe you should stick with it since we have 15-20 years of data on its side effects. Wait a while to see what the safety profile of this new med looks like after a couple of years."

That's about the time I pull out the baseball bat and start trashing the office demanding the oral meds.

dignan wrote: That's about the time I pull out the baseball bat and start trashing the office demanding the oral meds.

I LIKE your attitude dignan!

I agree that at that point it will be time to let our doctors know that they are the employees and we are the boss. While we appreciate their opinion, ours supercedes it.
Bob