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October 19th 2010
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The recent approval in the US of Novartis’ orally administered Gilenya (fingolimod) heralds a new phase in the treatment of Multiple Sclerosis (MS).
Over the last few years, the MS market has been driven by five disease-modifying agents: Teva’s Copaxone (glatiramer acetate), Biogen Idec’s Avonex (interferon beta-1a) and Tysabri (natalizumab), Merck KGaA’s Rebif (interferon beta-1a) and Bayer’s Betaferon (interferon beta-1b). From 2009, interferon beta-1b has also been available from Novartis as Extavia; this is the same formulation as Betaferon.
In addition to these, Amgen’s Novantrone (mitoxantrone) has been available to treat MS. Generic mitoxantrone is also available. Avonex, Betaferon/Extavia, Rebif and Copaxone are all used in first-line therapy for RRMS. They are generally well accepted and have accumulated comprehensive safety and clinical trial data supporting their use in modifying the course of the disease. Tysabri and mitoxantrone are generally used in second-line therapy in RRMS. Mitoxantrone is also approved to treat SPMS and PRMS. Both of these agents are associated with serious side-effects.
The arrival of oral treatments brings big clinical advantages
The development of oral therapies for MS has attracted significant investment from pharmaceutical companies and the first of these have begun to receive marketing approvals, signalling another major change in the way MS is treated. In September 2010, Novartis won the race to gain the first oral approval in the US with its sphingosine-1-phosphate (S1P) receptor agonist, Gilenya. The product was also approved in Russia in the same month. Merck’s oral product, Movectro (cladribine) was approved in Russia in July 2010 and in Australia in September 2010 for the treatment of RRMS for a maximum duration of two years. However, the European Medicine Agency’s CHMP issued a negative opinion for Movectro for the treatment of RRMS.
Espicom estimates the current MS market value is in the region of US$12.6 billion with strong growth going forward
Background to the disease
Multiple Sclerosis is a chronic autoimmune neurological disease affecting up to 2.5 million people worldwide, the majority of whom live in North America and Europe. It is a complex disorder that affects people in different ways. Around 85% of patients are initially diagnosed with relapsing remitting MS (RRMS). Up to half of these will go on to develop secondary-progressive MS (SPMS).
The other main types identified are primary progressive MS (PPMS), which affects around 10% of patients at onset, and progressive-relapsing MS (PRMS) which affects up to 5% of patients. There is currently no cure for MS and treatment is aimed at its symptoms and slowing disease progression. The launch of interferons during the 1990s transformed the treatment of MS but there is still a large unmet clinical need in reducing disease progression.
Shape of the industry in 2010...
At the forefront of the MS market is Biogen Idec, with a market share of 27% due to sales of Avonex and Tysabri. Following closely are Teva and sanofi-aventis who currently market Copaxone, giving them a combined share of the market by sales value of around 30%. With the third biggest seller, Rebif, Merck Serono has been attributed with a market share of 19%; Bayer Schering takes 15% of the market with Betaferon sales; while Elan’s share of Tysabri sales provide the company with around 4%.
...and in 2016
By 2016, a number of new agents will be available to treat MS, and their contribution to revenues will enhance Biogen Idec’s leading position. In addition, Teva’s Copaxone will lose patent protection in the US in May 2014. If approved, generic versions of Copaxone would undoubtedly put pricing pressures on both the branded version and related therapies. The combined effect of an influx of new therapies and generic competition for the market leader is likely to cause a ripple through the entire MS therapy market. Consequently, the current market leaders will all have their share of the US$15.3 billion market reduced as competition increases. Over US$4 billion of the MS market will be generated by recently approved or developmental products that will be launched in the near term.
Key company, market and product questions answered such as...
About the Author: The report has been researched and written by Espicom’s Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include: