Multiple Sclerosis (MS) is a disease that affects the central nervous system. MS is believed by most researchers to be an autoimmune disease in which the immune system incorrectly attacks the person’s healthy tissue. According to the National Multiple Sclerosis Society, morethan 400,000 Americans acknowledge having MS, and every week about 200 people are diagnosed. Worldwide, MS may affect over 2.5 million people according to the International Federation of Multiple Sclerosis Societies. Adis International Limited, a leading provider of business intelligence solutions for pharmaceutical and healthcare professionals worldwide, estimated that the global MS market reached sales of $US 2.9 billion in 2002 and is forecast to grow to $US 4.7 billion by 2006.

Last month, The U.S. Food and Drug Administration (FDA) approved Tysabri (natalizumab), formerly known as Antegren and jointly developed by Dublin, Ireland-based Elan Corp (NYSEADS: ELN) and Cambridge, MA-based Biogen Idec (NASDAQ:BIIB). Tysabri, the brand name for natalizumab, is a selective adhesion molecule (SAM) inhibitor and is designed to inhibit the migration of immune cells into chronically inflamed tissue where they may cause or maintain inflammation.

Symptoms and Diagnosis - MS symptoms result when the immune system attacks myelin, the fatty tissue that acts as protective insulation surrounding nerve fibers of the central nervous system (the brain, spinal cord and optic nerves). Myelin is destroyed and replaced by scar tissue, called sclerosis, in multiple places in the central nervous system and some underlying nerve fibers are permanently severed. When myelin or nerve fibers are lost or damaged, the ability of the nerves to conduct electrical impulses and send signals to and from the brain is disrupted. MS is not considered a fatal disease. 

Although most people with MS have a normal or near-normal life expectancy, symptoms of MS are unpredictable, vary from person to person, may be permanent or may come and go. MS can cause blurred vision or blindness, loss of balance and coordination, paralysis, slurred speech, numbness, fatigue, emotional lability, and problems with memory and concentration. 

Magnetic resonance imaging (MRI) is the preferred method of detecting the presence of MS lesions and plaques, areas of damage or scarring in brain or spinal cord, because the contrast of the tissue images produced by the MRI is significantly better than that from techniques including computed tomography or CAT scanning.

Major Pharmaceutical and Biotech Players - The MS drug market is presently dominated by interferon-based drugs since the introduction of Betaseron® by Montville, NJ-based Berlex Laboratories, a U.S. affiliate of Berlin, Germany-based Schering A.G. (NYSE ADS:SHR) in 1993. Other major interferon-based drugs include Avonex® by Biogen Idec, launched in mid 1996, and Rebif® by Geneva, Switzerland-based Serono, Inc (NYSE ADS: SRA) and New York, NY-Based Pfizer (NYSE:PFE) in early 2002. 

The only major non-interferon based market brand is Copaxone® (glatiramer acetate), introduced in 1996, by Jerusalem, Israel-based Teva Pharmaceutical Industries (NASDAQ: TEVA) and Parsippany, N.J.-based Aventis Pharmaceuticals (NYSE ADS:AVE), as distribution partner in North America. These drugs help to lessen the frequency and severity of MS attacks, reduce the accumulation of lesions and plaques in the brain, and may slow the progression of disability.

Based upon our estimation, the worldwide sales of MS drugs from these four pharmaceutical and biotech companies alone could exceed $US 5 billion this year. Although Betaseron® is still the number one MS drug in the market with over 35 percent market share, revenue growth derived from Copaxone® appears to have gained significant momentum.

Existing MS Drug Market  - Interferons, named for their ability to interfere with viruses that are replicating, are a group of naturally occurring proteins that are part of the body’s natural defense system and are normally produced by cells in response to viral infection and other biological triggers. Interferons beta and alpha are produced mainly by white blood cells and certain connective tissue cells called fibroblasts. 

Interferon beta helps limit the immune response and controls damage to the nerve cells by working like a key that fits into a special receptor on the cell. In the cell receptor, interferon beta turns off the chemical signal that promotes the immune response and turns on the signal that stops this response and the attack on the cell is called off.

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