October 1, 2007 (Vol. 27, No. 17)

Overwhelming Unmet Need Has Created Significant Growth Potential for Drugs

An estimated 2.5 million people suffer from multiple sclerosis (MS) worldwide—less than 0.04% of the global population. However, the epidemiology of the disease appears to be undergoing dramatic changes, and so are the approaches that pharmaceutical researchers and marketers are taking.

Multiple sclerosis is one of the most common of the serious neurological diseases affecting young adults in North America and Northern Europe. Traditionally the focus of research and treatment has been on these two regions. About 40% of the world’s MS cases occur in North America and Northern Europe, regions that have only 19% of the global population. Indeed, the Czech Republic alone appears to have as many MS cases as China.

However, regions of the globe that were considered to have very low incidence and prevalence of the disease even 10 years ago, the Middle East and South Asia especially, are now displaying an increase.

Going hand in hand with the rising incidence of the disease has been increased awareness of the risk factors and the potential for direct treatment of the disease globally. Japan, India, Iran, and Kuwait, for example, have instituted more aggressive surveillance and public health initiatives for MS.

The need and the market for effective treatments in the developed and developing world are thus growing. Truly effective treatments much less curative ones have been elusive. Research advances in MS have been slow-going in part because of the extremely unpredictable nature of the disease with its wide variety of clinical presentations. Symptoms can vary from day to day, and the disease may cause only mild disability with occasional exacerbations in some individuals but cause extreme progressive disability in others.

Etiology of the Disease

Also, the etiology of the disease is far from clear. MS appears to be autoimmune in nature, and there is evidence to suggest some combination of genetic and environmental factors. About 15% of multiple sclerosis patients have an affected relative, but no single gene has been identified as responsible. The current theory is that the disease occurs in people with a genetic susceptibility who are also exposed to some environmental factors that disrupt the blood-brain barrier.

A number of disease patterns have been documented in multiple sclerosis patients, and some experts believe that multiple sclerosis may prove to be not a single disorder but several disorders with different causes.

However, despite the lack of a cure, several approved treatments are now available to slow the progression of the disease and offer improved quality of life for people living with this condition.

There are nine products in Phase III clinical trials that could become available before the end of the decade, and at least another 13 in Phase II. With no truly breathtaking breakthroughs in the offing, however, the MS market in the short term will be dominated by four major approved therapies: Avonex, Betaseron/Betaferon, Copaxone, and Rebif.

Avonex, marketed by Biogen Idec (www.biogenidec.com), is an interferon beta-1a approved for the treatment of relapsing forms of multiple sclerosis. Avonex is the leading treatment worldwide for multiple sclerosis with total sales reported at $1.7 billion in 2006. This approximately $1 billion is generated in the U.S.

Rebif, marketed by Merck Serono (www.serono.com), holds the second largest share of the worldwide market. Sales reached $1.5 billion in 2006. Additionally, the product is the leading treatment in terms of sales for the European region. Rebif is an interferon beta approved for the treatment of relapsing-remitting multiple sclerosis.

Marketed in 47 countries worldwide, Copaxone is another big multiple sclerosis treatment. Sales for Copaxone reached $1.4 billion in 2006, an increase from $1.2 billion in 2005. Copaxone is a noninterferon therapy indicated for reducing the frequency of relapses in patients with relapsing-remitting MS. Copaxone is marketed in the U.S. and Canada by Teva (www.tevapharm.com) and distributed by sanofi-aventis (www.sanofi-aventis.com).

Betaferon, marketed by Bayer(www.bayer.com) in the U.S. as Betaseron, is also a leading multiple sclerosis treatment. Sales for Betaseron/ Betaferon exceeded $1.2 billion in 2006, increasing from $1.1 billion in 2005. Betaferon is manufactured by Chiron (now part of Novartis; www.novartis.com) for North American countries, Japan, and other select countries; while Boehringer Ingelheim (www.boehringer-ingelheim.com) manufactures the drug for European markets.

New Treatments Under Investigation

A number of treatments are under investigation that may prove to be helpful for multiple sclerosis. Aminopridines are potassium-blocking compounds that have been associated with mild to marked improvement in vision, strength, and coordination and are well tolerated. Another area of interest is plasmapheresis, which is thought to dilute antibodies that may trigger MS.

There is also great hope for stem cell treatments. Since 1995, a significant number of MS patients have been treated in clinical trials with autologous stem cells. The most current trial, Autogolous Stem Cell Transplantation International MS, is currently in Phase III with results expected in 2010 or 2011.

Until promising future treatments arrive, however, these four main drugs will make up the foundation of MS treatment. The current market for pharmacologic MS treatments is now nearly $6 billion, and that market has shown steady growth. The market has experienced double-digit growth over the past few years, with four of the six approved therapies generating sales exceeding $1 billion each in 2006. The addition of new formulations and competitors such as Merck Serono’s Mylinax (oral cladribine) possibly in 2008 and Novartis’interferon beta-1b will also contribute to increased revenues, which should approach $12 billion by 2011.

The overwhelming, unmet need in this population, the epidemiologic shifts occurring globally, increased public health attention, and the aggressive pipeline of new products from the pharmaceutical and biopharmaceutical industry are combining to create significant growth potential in the MS market and new hope for MS patients and their caregivers.

Melissa Elder is a pharmaceutical analyst with Kalorama Information. Kalorama’s Multiple Sclerosis Treatments: World Market Outlook to 2011 was published in June 2007. Web: www.kaloramainformation.com

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