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Biogen's BG12 Top Line Results: Exceeded Expectations

April 26, 2011

Analysis of:Biogen profit up; shares soar on drug data | www.reuters.com

Biogen announced positive top line result on April 11, followed by efficacy results on April 21. Both the 2x/day and 3x/day were positive. Relapses were reduced by 53% compared to placebo, and disability by 38% compared to placebo.

Gilenya Launch for Multiple Sclerosis Starts Slow for Novartis

November 11, 2010

Analysis of:Doctors Prescribed Novartis Gilenya MS Pill 13 Times, Citi Says | www.bloomberg.com

Gilenya became available in the US on Oct 4. Reports indicate just 13 enrollment forms within the first week. Numerous challenges lie ahead for a very effective therapy with very high expectations.

Teriflunomide by Sanofi Aventis Presents Positive Results in Multiple Sclerosis

October 18, 2010

At the ECTRIMS meeting in Sweden this past weekend, positive results from the TEMSO trial were presented.

Safety is Key in FDA Review of Novartis' Oral Med Gilenia (Fingolimod) for MS

June 6, 2010

Analysis of:PREVIEW-Safety fears hang over pioneering Novartis MS pill | www.reuters.com

The FDA will meet this week, with review documents potentially available early in the week. With remaining concerns for opportunistic infection, increased possibility of cancers, and a potential delay in the final FDA decision, will Gilenia be the first oral therapy in the US for MS?

Medicinova's Ibudilast (MN-166): Possible Neuroprotection in Multiple Sclerosis?

March 22, 2010

Analysis of:Surprising Phase II Clinical Trial Results of Oral Ibudilast Show Some Evidence of Neuroprotection But Little Impact Against Inflammation in MS | www.nationalmssociety.org

Ibudilast is an antiphosphodiesterase inhibitor, with putative anti-inflammatory and neuroprotective CNS effects. Phase II results have been epublished on Neurology's website in a paper by Barkhof et al.There was no effect on the standard markers of disease, such as relapse rate and active lestions. However, some additional analyses suggest a possible neuroprotective effect. The big question is whether this will be confirmed in a larger trial. At this point, some skepticism should be exercised.

Ampyra (Fampridine) Announced to be Available March 2010

February 3, 2010

Analysis of:Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA (Fampridine, 4-Aminopyridine) | www.cnbc.com

There have been several recent developments on Ampyra:

Fampridine Clears Major Hurdle at FDA Review Panel

October 14, 2009

Analysis of:FDA Panel Backs Proposed Acorda Multiple Sclerosis Drug (fampridine) To Improve Walking | online.wsj.com

Fampridine has been recommended for approval on 10/14. There are several more steps needed at the regulatory level, but the medicine is back on the approval track after a critical pre-meeting FDA report raised serious criticisms.

Fampridine's FDA Pre-Meeting Report Raises Concerns About Efficacy and Safety

October 12, 2009

Analysis of:FDA Questions Efficacy of Acorda's MS Drug (Fampridine SR) | www.thestreet.com

The FDA released it's pre-meeting review online this past Friday, and clearly had some concerns. Acorda will need to address these very thoroughly and seriously.

Acorda Therapeutic's Fampridine SR for Ambulation in MS Reported in The Lancet

February 27, 2009

Analysis of:Acorda says The Lancet will print Fampridine study | www.forbes.com

Fampridine SR is a sustained release version of 4-aminopyridine. Acorda has developed the compound for improvement of ambulation in MS, and has recently filed a NDA with the FDA.

First Tysabri PML Related Death Since Relaunch Reported Today

December 22, 2008

Analysis of:Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died | www.msrc.co.uk

Out of 4 post-relaunch PML cases announced, the first one has died. This is big news, as the announcement of a death may really make some people think about the drug under much more stark conditions.

Fourth MS Patient Identified with PML on Tysabri

December 17, 2008

Analysis of:Elan, Biogen report 4th case of brain disease in 2008 for MS patient on Tysabri drug | money.cnn.com

On December 11, a 4th person was identified with PML since the drug relaunch. No clinical details have been provided, although this person received 26 months of treatment and resides in Europe. A total of 7 cases have been identified with inclusion of the 3 in the clinical trials.

Multiple Sclerosis Oral Therapy FTY720 By Novartis Reports Positive Head-To-Head Data

December 15, 2008

Analysis of:Novartis’s Multiple Sclerosis Drug Cuts Relapse Rates | www.bloomberg.com

FTY720 may be among the first and the most promising oral therapies to arrive on the scene for MS . On December 12, Novartis reported the initial results of the 1-year TRANSFORMS study in relapsing MS. Compared with Avonex, FTY720 reduced relapses by an additional 40-50%. The annual relapse rate on Avonex was 0.33, and it was 0.16 for the higher-dosed arm of FTY720. This trial had over 1200 subjects. The results may put FTY720 on par with Tysabri.

Will Alemtuzumab Be A Revolutionary Treatment For Multiple Sclerosis?

December 11, 2008

Analysis of:Study Results: Multiple Sclerosis Patients Have Significant and Sustained Reduction in Disability and Risk Of Relapse On Alemtuzumab Versus Approved Therapy, Rebif(R) | www.marketwatch.com

Out of a crowded field of new MS therapeutics in phase III study, alemtuzumab has clearly distinguished itself from the rest. Although not a cure, the efficacy is nothing short of jaw-dropping. Most MS therapeutics are pitted against placebo, with a 30-60% reduction in relapse rate compared to taking nothing at all. However, the CAMMS223 had an unconventional study design in that they used Rebif, a medication already established to be highly effective in MS, as their comparison arm. The implication is that a much higher bar of efficacy is required, often needing very large numbers of participants.  For a phase II trial with only a few hundred participants, this must have been a very controversial decision at the time.

Upcoming Multiple Sclerosis Therapeutics: Hope, Risk, and Opportunities

December 9, 2008

Analysis of:Suspected PML Cases For Biogen, Elan MS Drug Not Alarming | www.djnewsplus.com

The next generation of MS therapeutics is beginning to emerge, and it appears to be a crowded field of contenders. To be determined over the next several years is how the standard agents will fit with the newer agents, what level of efficacy and/or convenience is needed to balance safety and risk, and how will these new medications fit together in clinical practice. The downturn in the market may present opportunities for the savvy investor.

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