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MS Patients May Soon Benefit from a New Generation of Oral Drugs


(Amherst, NH) – Multiple sclerosis (MS) is the most common chronic disabling disease of the nervous system. According to the U.S. National Institute of Allergy and Infectious Diseases, MS afflicts one in 700 people in the United States. MS is a relapsing, frequently progressive disorder that affects the myelin sheath or fatty cover of the central nervous system in the
brain and spinal cord and results in motor and movement impairment. Because MS primarily affects young adults in their 20s and 30s, the economic and social impact is significant.

The last ten years have seen improvements in the therapeutic options available to MS patients. Injectable interferons have demonstrated the ability to control MS symptoms, but not without side effects. The reformulation of Copaxone has provided an alternative efficacious drug option. The performance of these drugs in effectively treating MS has led to a measure of relief for patients and financial success for drug suppliers. Now a number of oral drugs for treating various forms of multiple sclerosis have reached late-stage clinical development, and their eventual commercialization could have a significant impact on the market for MS therapeutics.

“Suppliers of the top five FDA approved drugs for treating MS recognized a total of $8.5 billion in 2008,” explains George Perros, Greystone Associates Managing Director. “The top four recorded average ex-manufacturer revenues of $ 2 billion, and we expect the fifth, Tysabri, to reach the billion mark in 2010. All five are delivered by either injection or IV. Oral drug candidates in late-stage development are now preparing to spoil the party.”

Oral drug candidates in late-stage development are now preparing to spoil the party.”

Or not … I want a pill worse than the next person, and although Cladribine isn’t my personal first choice, I was shocked to read the following press release from Merck this past April at the annual meeting of the American Academy of Neurologists. Cladribine, which is likely to become the first FDA-approved pill for MS, is produced by Merck.

"Cladribine is taken very infrequently when compared to many MS drugs that are taken daily. In the study, patients were given two or four treatment courses in the first year, with each course being a daily pill for four to five consecutive days. In the second year, two treatment courses were administered to all patient groups.
Despite its infrequent dosing and being a pill, rather than a biologic, Merck will likely be aggressive in pricing the drug.
"I think that pricing has to be in line with the benefits that the drug brings to the patient," Schnee said. "It doesn't differ if you have an injectable or if you have a tablet."
Biogen's Avonex, the MS market leader, is currently sold for about $30,000 a year."

I’m very excited that pills seem to be coming out of the pipeline, but I’m afraid they’re going to be just as expensive as the CRABS. For our sakes, I hope Mr. Perros is correct. Time will tell, I guess.