Biotech Values

[jbog]

Dew,

I don't think NVS was ever intended to report on FTY720. I think this rumor started with an seeking alpha story which said the results were "likely" to be released. ( http://seekingalpha.com/article/160335-novartis-powering-into-the-multiple-sclerosis-market)

What was released was a rehash of their Transforms trial:

Oral Fingolimod Shows Superior Clinical Efficacy Compared With Interferon Beta-1a in Relapsing-Remitting MS: Presented at ECTRIMS
By Chris Berrie

DÜSSELDORF, Germany -- September 14, 2009 -- Oral fingolimod shows significantly superior clinical efficacy compared with intramuscular (IM) interferon (IFN) beta-1a in patients with relapsing-remitting multiple sclerosis (RRMS), researchers stated here at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The multicentre, randomised, active-comparator, double-blind, phase 3 study was presented by principal investigator Jeffrey Cohen, MD, Neurological Institute, Cleveland Clinic Foundation, Cleveland, Ohio, on September 10.

The study included 1,292 patients aged 18 to 55 years with RRMS. Patients were randomised to 12 months of treatment with IFN beta-1a 30 mcg IM once weekly with matching oral placebo (n = 435), or once-daily oral fingolimod 0.5 mg (n = 431) or 1.25 mg (n = 426) with matching weekly placebo injection. Of the patients, 89% completed the study.

The primary endpoint was annualised relapse rate at month 12, which was significantly lower for both the low-dose (0.16) and the high-dose (0.20) fingolimod-treated groups compared with patients treated with IFN beta-1a (0.33; P <= .001 for both).

The proportion of relapse-free patients at 12 months was significantly higher in the fingolimod treatment groups (0.5 mg, 83%; 1.25 mg, 80%) compared with IFN beta-1a (69%; P < .001 for both).

Significant beneficial improvement was seen in the Expanded Disability Status Scale (EDSS) score for patients receiving the high-dose fingolimod versus IFN beta-1a (-0.11 vs +0.01, respectively; P < .05).

"These analyses were also supported by a number of positive results on magnetic resonance imaging," said Dr. Cohen.

These were presented separately, with main improvements over IFN beta-1a treatment with low- and high-dose fingolimod observed to month 12 for reduced mean new or enlarging T2 lesions, reduced Gd-enhancing T1 lesions, and beneficial change in mean brain volume.

"This is a very promising potential therapy that looks to be very effective and appears to be in general very well tolerated," Dr. Cohen concluded.

Funding for this study was provided by Novartis Pharma AG.

[Presentation title: Oral Fingolimod (FTY720) Significantly Reduced Relapse Rate Compared With Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Clinical Results From a 12-Month Phase 3 Study (TRANSFORMS). Abstract P434]

The Freedoms trial probably won't be released for awhile.