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Novartis AG said a study shows that 80-83 percent of patients taking its multiple sclerosis drug FTY720 are relapse-free compared to 69 percent of those on the leading current treatment.

Novartis, which is presenting new Phase III results to the American Academy of Neurology, said the data reinforces results announced in December that showed the annual relapse rate was 52 percent lower compared with patients taking Biogen's injectable multiple sclerosis drug Avonex.

It said full results from the so-called TRANSFORMS study would be submitted to a peer-reviewed journal in the next few months, adding regulatory filings were on track for the United States and European Union at the end of 2009.

Lead investigator Jeffrey Cohen said the trial showed that FTY720 "may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis".

Novartis AG and Germany's Merck KGaA are leading the charge to develop MS drugs that can be taken orally, rather than by infusion or injection, but the firms must persuade physicians and investors that the treatments are safe.

Novartis said serious adverse effects were reported in fewer than 2 percent of patients treated with FTY720 and said a role for the drug in the death of a patient in February could neither be confirmed nor ruled out.

It added that the safety profile of a 0.5 mg dose appeared to be better than the 1.25 mg dose.

"The results are statistically significant," said Vontobel analyst Andrew Weiss. "Somewhat comforting is the fact that no new safety concerns in the TRANSFORMS trial have emerged."

Novartis also presented longer-term results from a Phase II study that showed continued low relapse rates after four years of treatment, with no change in the safety profile.

FTY720 has been associated with potentially fatal infections, skin cancer and, recently, a case of haemorrhaging focal encephalitis, an inflammation of the brain with bleeding. It is unclear whether the drug was responsible for the events.

Merck's drug, Cladribine, has been linked to a reduction in white blood cells, which can lead to infection, and in January the company said four patients in a late-stage trial were diagnosed with cancer. It is also due to present study results at the neurology meeting in Seattle.

Earlier this year Merck said results of a late-stage trial showed Cladribine reduced the number of relapses per year by as much as 58 percent, compared with those taking a placebo.

Biogen is developing an oral MS drug, known as BG-12, but it is not as far advanced as the Merck or Novartis drugs.

Source: Reuters.com © Thomson Reuters 2009 (29/04/09)

Novartis released its 2nd quarter results yesterday. Fingolimod is still on track for filing by the end of this year. Here’s the blurb on it:

“FTY720 (fingolimod), a novel oral development therapy for multiple sclerosis, showed continued low relapse rates after four years in patients with relapsing-remitting MS in an open-label Phase II extension study. The data, presented at the American Academy of Neurology (AAN) meeting in April, also showed no significant change in the safety profile from three to four years. Data at AAN from TRANSFORMS, a one-year Phase III trial against interferon beta-1a (Avonex®), showed 80-83% of MS patients given FTY720 were relapse-free for one year compared to 69% of patients treated with Avonex® (p<0.001), with a safety profile for FTY720 in line with previous experience. US and European regulatory submissions are expected by the end of 2009. Initial results of the Phase III placebo-controlled FREEDOMS trials are also expected in the fourth quarter of 2009.”

Novartis released its 3rd quarter results today. They still plan on filing for approval for Fingolimod by the end of this year. And since I have a calendar in front of me, I can tell you there are only 70 days left until December 31!
Here's the link to the release. I can't copy it, but the Fingolimod paragraph is the third paragraph on page 14. If you get a message about reading an untagged document, just hit cancel. http://www.novartis.com/downloads/inves ... ort_EN.pdf

This paragraph appears at the bottom of page 4 in Novartis’ press release today. I hadn’t known about the “rolling submission.” So it sounds like they’re nose-to-nose with Cladribine…

· FTY720 (fingolimod), a once-daily oral compound in development for certain forms of multiple sclerosis, is on track for completion of regulatory submissions by the end of 2009 in Europe and the US, where it has been granted fast-track status that enabled a "rolling submission" process initiated in June. FTY720 has a well-studied safety profile with more than 5,300 patient-years of exposure, including patients now in their sixth year of treatment. FTY720 was licensed from Mitsubishi Tanabe in Japan.

http://hugin.info/134323/R/1359994/331705.pdf