This is going to be a long race.
For now there is no cure, and there isn't one in sight. All the existing drugs do is slow down the progression of the disease and alleviate symptoms.
Sales: These are the worldwide sales figures of the leading brands for the first quarter of 2012, sourced from company reports:
Copaxone from Teva (NYSE:TEVA) $941 million, Tysabri from Elan (NYSE:ELN) and Biogen (NASDAQ:BIIB) $685 million, Avonex from Biogen $661 million, Rebif from Merck KGaA (the German Merck) and Pfizer (NYSE:PFE) $559 million, Betaseron from Bayer (OTCPK:BAYRY) $381 million and Gilenya from Novartis (NYSE:NVS) $247 million.
Copaxone is the world's bestselling MS drug. Sales may drop in two years time though, when its patent protection ends. Teva has run trials and will try to get approval for a new concentrated version of Copaxone that can be injected 3 times a week, down from the current 7 times a week.
Research: Multiple sclerosis is a disease not well understood.
It is thought to be an autoimmune disease of the central nervous system that is chronic, progressive, and often disabling. The body's immune system attacks myelin. Myelin is the fatty sheath surrounding and insulating the nerve fibers in the central nervous system (CNS), which consists of the brain, spinal cord, and optic nerves.
The exact target of the immune cells remains unknown. In recent years, however, researchers have been able to identify which immune cells are mounting the attack, some of the factors that cause them to attack, and some of the receptors. MS affects over 400,000 Americans and more than 2.1 million people worldwide. Relapsing forms of MS, the most common type, are characterized by "flare-ups" interrupted with periods of disease remission.
Research is ongoing. In the US government clinical trial database under "multiple sclerosis," 895 studies are listed. MS-related health care costs are estimated at $10 billion annually in the United States.
Dosing: There is a wide variation in dosing and in the method of administering the medications.
Although a drug should not be selected on the basis of convenience, for lifelong illnesses it is an important factor.
The first line treatments Avonex, Betaseron, Copaxone, and Rebif are injected at various intervals. Betaseron is administered every 2 days, Avonex once a week, Copaxone daily, and Rebif 3 times a week. Tysabri, currently a second line treatment, is infused by IV once a month.
As in some other treatment areas, oral medications for MS have also begun to appear. Gilenya is a once daily pill. Right now it is the only approved oral drug, but more are on the way. BG-12 (dimethyl fumarate) from Biogen will be a twice daily pill when and if it is approved by the FDA in December, 2012.
Aubagio (Teriflunomide) from Sanofi will be a once daily pill. Another upcoming medicine from Sanofi is Lemtrada (Alemtuzumab or Campath), which is given just once a year as an intravenous infusion for 3-5 days. In clinical trials, it was given as an IV infusion for 5 days and again for 3 days one year later.
According to Biogen, in the Confirm trials, BG-12 cut the rate of disability progression by 21% when given twice a day and by 24% when given three times a day. Copaxone cut the rate of disability progression by 7%. Confirm has also shown that BG-12, when given twice a day, cut the annualized relapse rate in patients by 44% at two years compared with a placebo.
Also, BG-12's competitive advantage may lie in its safety profile, which looks relatively clean based on two-year data. The most common side effects in the Confirm trial were flushing and diarrhea. These positive features of BG-12 could give it an advantage over Novartis's Gilenya, which was slapped by the FDA with new monitoring requirements.
The FDA ordered an initial observation period for all new patients starting on Gilenya. Hourly pulse and blood pressure measurements are required as is an electrocardiogram prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until all symptoms resolve.
Sanofi: Compared with older therapies, Sanofi (NYSE:SNY)'s Aubagio (teriflunomide) has the advantage of being an oral drug. Aubagio is the name that will be given when and if the drug is approved.
The Tenere study compared two oral doses of teriflunomide to standard-dose treatment with Merck KGaA Rebif, and found that Sanofi's drug was no better at preventing treatment failure and cutting the number of relapses patients suffered in a year. On the other hand it had a milder side effect profile.
Sanofi's Lemtrada, however, proved more effective than Rebif in a trial called CARE-MS II. The trial showed Lemtrada outperforming Merck Serono's Rebif and meeting both of the study's primary endpoints. Lemtrada reduced relapses by approximately 50% compared to Rebif. Some studies have found that disability progression has been halted, and in some cases reversed.
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