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WIKI ANALYSIS
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This article describes a concept which could impact a variety of companies, countries or industries. To see what companies and articles reference this concept page, click here. |
Multiple sclerosis (MS) is a progressive and debilitating disease of the central nervous system that often causes physical and mental disability. MS affects 400,000 people in the United States and over 2.5 million people worldwide.[1] Although the effects of the condition are well-documented, the cause is not known for sure and there is no cure.
Current drugs only reduce the frequency of relapses or slow the progression of the disease, and had worldwide combined sales of $7.0 billion in 2007.[2] Beta interferon-based drugs (Biogen's Avonex, Merck Serono's Rebif, and Bayer's Betaseron) are the most common treatments, but also cause flu-like side-effects that cause 20 percent of patients to stop.[2] Also, the patient's immune system may eventually make antibodies against the drug molecules (neutralizing antibodies, or nAbs), diminishing its efficacy.[2] Teva's Copaxone has less side effects and does not lead to tolerance, but may also be less effective and does not slow the disease. Biogen's Tysabri is more effective and has less side effects than older treatments, but was temporarily recalled in 2005 after it was linked to a rare brain disease and has since been relauched.[3]
Major players in the multiple sclerosis market
- Biogen - Avonex (interferon beta-1a) is slows the progression of MS and reduces relapses. As the most prescribed MS drug, it had sales of $1.9 billion in 2007 and there are 130,000 patients taking the drug worldwide.[2][5] As one of the first interferon MS drugs to market, it originally received competition protection from the orphan drug act. Avonex is an extremely important drug for Biogen, accounting for 59% of total revenue for the company.[6] Sales increased by 9.4% in 2007, representing 32.8% of total revenue growth.[6][7] Avonex is delivered via intramuscular injection once a week.[8]
- Merck Serono - Rebif (interferon beta-1a) is a higher-dose version of a drug that is very similar to Avonex. Rebif is more effective, but also causes more side-effects than Avonex.[9] Avonex is more popular in the U.S., but Rebif has the highest market share outside of the U.S. where it was available earlier and more agressively marketed.[2] Worldwide sales of Rebif were $1.7 billion, which accounted for more than half of sales for Merck Serono before it was bought by Merck KGaA. Rebif is delivered in 44 mcg doses three times a week by subcutaneous injection.[9]
- Bayer - Betaseron (interferon beta-1b): Similar to Avonex and Rebif, Betaseron is the highest dose interferon available, and like Rebif, it is more effective but also less tolerated than Avonex. 2007 sales of the drug were $1.4 billion. Betaseron is delivered in 250mcg doses by subcutaneous injection every other day.[10]
- Teva / Sanofi Aventis - Copaxone (glatiramer acetate) was the only non-interferon based MS drug on the market until the launch of Tysabri.[2] Unlike interferons, it does not cause the flu-like side-effects and patients do not develop neutralizing antibodies. Copaxone's efficacy compared to interferons has been debated -- in one clinical trial, it was not shown to be effective in halting disease progression, but in a later study, no significant difference was found between Copaxone and interferons.[11] 2007 sales of the drug grew by 19% to $1.7 billion.[12] Copaxone is delivered in 20mcg doses by subcutaneous injection once per day, but Teva is developing a higher, 40mcg dose that has shown positive results in Phase II trials.[11][12]
- Biogen / Elan - Tysabri (natalizumab) is a humanized monoclonal antibody that is more effective than older treatments. When used in conjunction with interferon treatments such as Avonex, it is more effective than interferon alone.[8] Tysabri was originally approved in 2004 through an expedited review process and once hailed as a $2 billion blockbuster, but Biogen and Elan recalled the drug after it was linked to a rare fatal brain condition called progressive multifocal leukoencephalopathy (PML) in 2005.[8][13] After reviewing two years of safety data, the FDA has since reapproved of the drug and it is currently being relaunched. In June 2008, two years after the relaunch, the CEO of Biogen has stated that Tysabri is on track to surpass $1 billion in annual sales.[3] Tysabri is delivered via intravenous infusion once every 28 days and is also indicated for Crohn's disease, an autoimmune condition of the bowels.[14]
What is multiple sclerosis?
Multiple sclerosis (MS) is a chronic disease of the central nervous system (the brain, spinal cord, and optic nerves) that may affect motor function, vision, and thinking.[15] No one knows for sure what causes MS, but it is thought to be an autoimmune disease in which the body's immune system attacks the protective layer on nerve fibers (mylein). This leads to scars (sclerosis), disruption of nerve signals, and eventual disability.[16]
MS affects 400,000 people in the United States and over 2.5 million people worldwide.[1] The disease is not contagious or directly inherited, but there are environmental and genetic factors that increase risk. Women and people of northern European ancestry are at greater risk.[1] There is greater incidence of MS in colder climates than the tropics, which some researchers hypothesize is due to the lack of sunlight exposure that provides vitamin D.[1]
References
- ↑ 1.0 1.1 1.2 1.3 Who gets MS? : National MS Soceity.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 Cowen and Company. Therapeutic Categories Outlook, March 2008
- ↑ 3.0 3.1 Biogen CEO: Tysabri to reach $1B in 2008.
- ↑ Company annual reports
- ↑ BIIB 10-k pg. 3
- ↑ 6.0 6.1 BIIB 10-k pg. 46
- ↑ BIIB 10-k pg. 50
- ↑ 8.0 8.1 8.2 Wikipedia:Interferon beta-1a
- ↑ 9.0 9.1 Rebif InfoSite.
- ↑ Betaseron (Interferon beta-1b drug indications and dosage).
- ↑ 11.0 11.1 Wikipedia:Copaxone
- ↑ 12.0 12.1 TEVA 20-F pg. 26
- ↑ Tysabri: Death Prompts Withdrawal Of Promising MS Drug: Biogen Idec, Elan Recall Tysabri After Users Contract Rare Disorder; Encouraging Words From FDA.
- ↑ Wikipedia:Natalizumab
- ↑ Symptoms : National MS Society.
- ↑ What is Multiple Sclerosis? : National MS Society.
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