MS Drug Fampridine Sends Acorda Stock Way Up

Acorda Therapeutics (ACOR) announced positive results from its second Phase 3 clinical trial of Fampridine-SR on walking ability in people with multiple sclerosis [MS]. In a timed, 25 foot walk test, just under half of the patients showed improved walking speed vs. placebo. Acorda plans to submit an NDA in 2009.

This was an interesting endpoint. I could be wrong but these two trials from Acorda may have been the only of their kind. Most trials have an endpoint of reduction in MS flare up incidence, or something relapsing remitting related that require a study length of 1-3 years.

MS is characterized by the progressive demylenation of nerves and while most all approved MS therapies are geared towards preventing the immune system from attacking the myelin, Fampridine works on the nerve itself by preventing ions [K+] from leaking out of the damaged neurons and preventing the degradation of the nerve signal.

Acorda got an Special Protocol Assessment [SPA] with the FDA prior to the trials and seems confident of these endpoints, this data support and NDA. While the data doesn ’t knock my socks off (Fampridine only increased average walking speed in 42% of patients and only by 29%) the fact that this may be the first oral therapy approved for MS is a huge deal.

Also in Acorda’s favor is the frighteningly low cost of goods sold. Off hand, I don’t know what the cost will be but Fampridine is simply 4-aminopyridine and must cost fractions of a penny per dose.

Good news all around for both Acorda shareholders and MS patients.

Comments

[Rocco Verducci:]

Eben,

The mechanism of action for this compound is unique. Since it doesn't approach MS from an auto-immune vantage point it would make this a natural as an adjunctive therapy.

The unknown is who the Acorda marketing partner would be. The company has a 14-person internal sales force and a 160-member contract sales force selling Zanaflex and this doesn't appear to be the critical mass necessary to provide the educational and marketing effort to have Fampridine-SR recognized as a primary treatment for MS.

At the end of the day, you need to have an innovative molecule coupled with a great company to extol the benefits (and risks) of a particular compound and to make it commercially viable.

Ciao,

2008 Jun 03 05:08 PM

[Shilpa C Na...:]

Eben, nicely written article on rising Acorda's shares!

Really its awful to see the pain and injection site reactions faced by many MS patients to inject the drugs themselves, so if a oral MS pill is approved then it would be more comfortable for these MS patients!!! So I am waiting to see a satisfied joyous smile on such patients waiting for oral MS drug :-)

Regards,
Shilpa C Nangali

2008 Jun 04 12:58 AM

[PTB:]

doesn't this make acorda a good bet for a sale to a larger company like teva or biogen, the latter of which already have an establish MS drug market?

2008 Jun 04 10:39 AM

[barkingdog:]

there is no IP so nobody is buying them, 4AP is bird poison that will cause seizures once removed from the safe confines of a controlled clinical study, and the benefit of famp has little clinical relevance -- you can walk 25 feet a few seconds faster?...oooh eeee, how exciting...dont blv for a second this gets through an fda panel...watch for insider selling...cohen and insiders know what to do

2008 Jun 06 03:33 PM

[Luisa Paes ...:]

4AP has been used in portuguese Hospital Santa Maria during 10 years with fantastic results. It was fabricated at de pharmacy of the hospital. One day the EU forbid the production and Portugal too. I have MS and my doctor said that 4ap was the best remedie for MS. Act like a kind of "Benuron" to ms. When can I have this medicine again? Most people dont know the difficult we have to walk withou fall, walk like a drunker. Everyone put us appart a we become alone. Please hurry
Best regars
Luisa Paes de Vasconcellos

2008 Jun 23 11:20 AM

[Jgirl:]

whoaaaaaaaa barkingdog. You really need to take a look at the info. on the Fampridine trials, that I have been a part of for 5 years. Yes, I have MS and this drug has been a godsend for me and many others. It not only improves walking speed but most other MS symptoms as well. It is a potassium channel blocker that increases nerve signals that improve many symptoms which I and many others with MS suffer from on a daily basis.

Also, I'd like to mention what Shilpa C Nangali talked about in his comment. Fampridine is not meant to reduce the number of relapses and slow progression like the Interferons, Copaxone, Novantrone and Tysabri are designed to do. It is a drug for help with the severity of the symptoms people with MS experience. It is really wonderful to read what Mr. Nangali said. It's nice to see someone so excited for people with MS. It makes my day. Thanks:)

I just wanted to add my 2 cents here..
Veronica

2008 Jul 08 03:33 PM

[nord:]

I know someone with MS. She suffers a variety of symptons, including difficulty walking, but intention tremors are by far her worst sympton. Given the mechanism of action of Fampridine, seems like it could help across a much broader range of symptons than just walking ability, and I have some hope that Fampridine could make a difference for her.

en.wikipedia.org/wiki/...

2008 Aug 16 06:43 PM

[persephone1:]

I was on the 2nd Phase 3 trial of Fampridine. I have secondary progressive MS, and my main symptoms are lack of balance and muscle weakness. After a year of taking Fampridine, I can testify to how well it works: I can walk much more easily, I'm much more mobile, my muscle strength has improved 100%. I could go on--but suffice it to say, without Fampridine, I quickly revert to my former state of muscle weakness and no balance. This drug is MAJOR. True, it is not a cure, but it really helps with many MS symptoms.

Jan 15 05:56 PM

[User 400998:]

DOES ANYONE KNOW WHEN IT WILL BE AVAILABLE TO ALL OF US? IS IT AVAILABLE IN U.S.? I LIVE IN CANADA BUT WOULD BE WILLING TO TRAVEL. I HAVE QUICKLY PROGRESSING SECONDARY PROGRESSIVE MS AND NEED SOMETHING ASAP.


On Jan 15 05:56 PM persephone1 wrote:

> I was on the 2nd Phase 3 trial of Fampridine. I have secondary progressive
> MS, and my main symptoms are lack of balance and muscle weakness.
> After a year of taking Fampridine, I can testify to how well it works:
> I can walk much more easily, I'm much more mobile, my muscle strength
> has improved 100%. I could go on--but suffice it to say, without
> Fampridine, I quickly revert to my former state of muscle weakness
> and no balance. This drug is MAJOR. True, it is not a cure, but it
> really helps with many MS symptoms.

Apr 23 06:38 PM