Flingolimod and others

[scoobyjude]

Multiple Sclerosis: A Breakthrough Is on the Way
A number of improved treatments will be available soon, and Novartis' Fingolimod could lead the way
By Kerry Capell
January 11, 2010


When Thomas Bullock was diagnosed with multiple sclerosis in 2001, several new treatments for the incurable, nerve-destroying condition had just hit the market. The automotive worker from Ontario spent two years on Bayer's blockbuster Betaseron, an injectable drug that can suppress a hyperactive immune system. But instead of getting better, Bullock endured constant flu-like symptoms and numbness in his limbs. When he developed severe nerve damage, he ditched the injections. "My body just couldn't handle it," recalls Bullock, now 41.

Then, in 2007, he joined a clinical trial for an experimental pill, Fingolimod, from Novartis (NVS). His MS hasn't flared up since. "This is the best shape I've been in for years," he says.

Bullock is one of an estimated 2.5 million MS patients worldwide with fresh cause for hope. Fingolimod and a slew of other drugs that attack MS in new ways are expected to become available starting in 2010. With 10 treatments in late-stage development and more than two dozen in early-stage research, some doctors believe therapy for the illness is at a turning point. Although doctors can't say which drugs will succeed, "we are getting closer to stopping the progression of the disease," says Dr. John Richert, a top executive at the National Multiple Sclerosis Society.

Switzerland's Novartis is vying with Germany's Merck to be first with an oral treatment, pursued closely by France's Sanofi-Aventis (SNY), Israel's Teva Pharmaceuticals (TEVA), and Biogen Idec (BIIB) in Cambridge, Mass. If regulators approve any or all of these products, the painful injections and infusions patients endure today may become obsolete—and the global market for MS drugs, currently at $8.8 billion, could double within five years, according to consultants Frost & Sullivan.

When MS strikes, rogue immune cells travel to the brain and spine, attacking and destroying myelin, the protective insulation surrounding nerves. These mysterious attacks produce sclerotic scar tissue and disrupt messages from the brain that control muscle movements, with symptoms ranging from mild numbness to paralysis and blindness.

MS drugs seek to quell these assaults. But any tampering with the body's immune reactions can be dangerous. "There is balance between treating the disease and potentially increasing the risk of infection and cancer," says Dr. Jeffrey Cohen, director of experimental therapeutics at the Cleveland Clinic's Mellen Multiple Sclerosis Center. Consider Tysabri, one of the most potent weapons against MS, which works by confining wayward immune cells in the bloodstream. The drug, made by Biogen Idec and Elan Pharmaceuticals (ELN), has been used by 65,000 patients. Of these, 28 have developed brain infections, and 7 have died.

The new wave of MS drugs face tough scrutiny. Fingolimod, for one, works through an entirely new mechanism: It traps the marauding immune cells in the lymph nodes, keeping them from entering the bloodstream. A two-year study shows it reduced the relapse rate in MS patients by 54%. It also may increase the nervous system's ability to protect itself, as may Biogen Idec's new pill, BG-12, says Richert.

What doctors can't guarantee is that the drugs will suppress the illness without triggering infections. "We desperately need new drugs for MS," says Dr. Mark Keegan, section chair of multiple sclerosis at the Mayo Clinic in Rochester, but "any new medication that alters the immune system needs to be used with caution."

[scorpion]

Great article. Lets keep our fingers crossed!

[Needled]

As of December 9, Novartis said it was still on track to file its application for Fingolimod with the FDA by 12/31/09. I didn't get a press release or see anywhere else that it happened, so I don't know what the delay is. Hopefully it shows up next week.