It’s a disease that doesn’t often find itself in the spotlight, but multiple sclerosis is quickly becoming an ailment that drugmakers are focusing their efforts on to make a quality-of-life difference for patients.
MS is a disease in which the body’s own autoimmune system attacks its central nervous system, consisting of the brain, spinal cord, and optic nerves, disabling it over time. Some of the symptoms of MS can be relatively minor, such as tingling of the limbs, but others can be considerably more severe, including loss of vision and/or paralysis.
In recent years, the incidence rate of MS has been on the rise. However, one of the few tidbits of good news here is that this may be because of earlier and proper diagnosis rather than an actual increase in MS as a disease.
In total, an estimated 400,000 people in the U.S. suffer from MS, with approximately 10,000 new cases diagnosed each year. Women are more susceptible than men to getting MS, with the diseases in both genders most often diagnosed between the ages of 20 and 50. Researchers have also discovered a correlation between age and aggressiveness of the disease. The older a person is at the time of their diagnosis, the more aggressive the disease tends to be.
With this in mind, biopharmaceutical companies have been working their behinds off to create medications designed to slow down or stop the degradation of the central nervous system brought on by MS. While we’d love a cure, there are still too many unknowns about this disease to even dream of one at the moment.
Where we’ve been
Two drugs that have had a long-tenured and rich history in treating MS over the years are Tysabri and Copaxone.
Tysabri is a drug that was developed by Elan and licensed by Biogen Idec Inc. (NASDAQ:BIIB) to treat patients with relapsing MS. It was approved by the Food and Drug Administration in 2004 and generated $1.6 billion in sales last year. Recently, Biogen Idec Inc. (NASDAQ:BIIB) ponied up $3.25 billion, plus future royalties, to purchase the full global rights to Tysabri from Elan. In addition, Biogen Idec Inc. (NASDAQ:BIIB) is testing Tysabri as a treatment for secondary-progressive MS, a form of the disease that comes after relapse-remitting MS and progresses at a much faster pace. Although Tysabri’s days as a patented drug for relapsing MS are numbered, Tysabri’s overseas opportunity, and perhaps even domestic opportunity in a new indication, is still bright.
The same can be said for Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA), whose once-daily relapse-remitting MS injection, Copaxone, has been nothing short of a blockbuster. Even more impressive, for Copaxone you have to go all the way back to December 1996 to find its FDA approval date! Copaxone is a $4 billion-plus drug for Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) and accounted for close to 20% of its revenue last year — but it’s also only two years away from losing patent protection.
Where we are now
We’ve come an incredibly long way over the past three years in MS treatments. Specifically, we’re beginning to see a shift away from injection-based administration to pill form.
Novartis AG (ADR) (NYSE:NVS) led things off in 2010 with the approval of Gilenya, a capsule-based relapsing MS treatment that is cleared for use in first-line and second-line MS cases and works by blocking some red blood cells in lymph nodes and curtailing their travel to the brain and spinal cord. Overall, Gilenya delivered $1.2 billion in net sales worldwide in 2012, a 142% increase in U.S. dollars. The one downside to Gilenya, though, is that it can lower a patient’s heart rate, which has the potential to cause cardiovascular problems, and in rare cases it’s been linked to macular edema and liver problems.
Last September, Sanofi SA (ADR) (NYSE:SNY) brought Aubagio, a capsule-based relapsing MS drug, to market. In trials, Aubagio was quite effective, reducing the relapse rate of MS patients by roughly 30% relative to the placebo. However, being slapped with a black-box warning by the FDA for severe liver problems that can lead to death have seriously curbed its sales potential. In the second quarter, Aubagio brought in just $44 million in sales.