Multiple Sclerosis Drug Discoveries - What the Future Holds

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Multiple Sclerosis Drug Discoveries - What the Future Holds

Description: 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.

This report 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.

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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... - What are the four main types of MS?

- Research into MS vaccines has stalled. What is the current situation and are there still opportunities in this area?

- How might the asthma treatment salbutamol (albuterol) help control MS? - Which countries have the highest prevalence of patients per 100,000 population? - MS is a geographically specific condition – what are the theories as to why this is so?

- Despite having patent protection until 2014, generic companies are already making a play for Teva's Copaxone. Who's involved and what is the current status?

- What are the expected sales in 2016 of Novartis' novel oral MS treatment Gilenya?

- What are the patient safety concerns with Biogen Idec's Ampyra (dalfampridine), the first in class treatment for treating MS symptoms?

- How many Phase III products are in the pipeline and when are they expected to launch? - What positive clinical trial results did sanofi-aventis report for its oral MS drug teriflunomide? More Information...

- Unique market share and 5-year sales forecasts for leading products, pipeline prospects and companies - A comprehensive examination of the multiple sclerosis market and disease prevalence

- Critical competitive evaluation and scoring of current and future products This report delivers real insights to MS drugs, prospects and companies… - Evaluate the current clinical understanding of multiple sclerosis

- Know the disease prevalence trends in major markets

- Contrast and compare the competitive landscape in 2010 and 2016

- Profile product potential with original 5-year sales forecasts for current products

- Compare and review up and coming Phase II/III products with 5-year forecasts from year of launch for significant late-stage candidates

- Benefit from this unique product assessment and scoring

Contents: FOREWORD

EXECUTIVE SUMMARY MARKET ANALYSIS CURRENT MARKET FUTURE MARKET What's in the Pipeline? MS Vaccines in Limbo?

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BACKGROUND INFORMATION What is MS?

Why are New Treatments Needed? Patient Statistics

PRODUCT ANALYSIS ESTABLISHED PRODUCTS Copaxone (glatiramer acetate) Mode of Action

Current Status Approvals/Filings Development

Proof of Concept/Clinical Data Development Risks

Company Expertise

Competition within the Market-place Patents and Exclusivity

Generic Competition Competitor Ratio Analysis Forecast

Clinical Trial Results Avonex (interferon beta-1a) Mode of Action

Company Expertise

Competition within the Market-place Patents

Competitor Ratio Analysis Forecast

Clinical Trial Results

Betaferon/Betaseron & Extavia (interferon beta-1b) Mode of Action

Company Expertise

Clinical Trial Results Rebif (interferon beta-1a) Mode of Action

Company Expertise

Competition within the Market-place Competitor Ratio Analysis

Forecast

Clinical Trial Results Novantrone (mitoxantrone) Mode of Action

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Current Status Approvals/Filings

Company Expertise

Competition within the Market-place Generic Competition

Competitor Ratio Analysis Clinical Trial Results Tysabri (natalizumab) Mode of Action Current Status Approvals/Filings Development

Company Expertise

Clinical Trial Results

NEW APPROVALS/FILED PRODUCTS Gilenya (fingolimod)

Mode of Action Current Status Approvals/Filings Development

Company Expertise

Forecast

Clinical Trial Results Movectro (cladribine) Mode of Action Current Status Approvals/Filings Development

Company Expertise

Forecast

Clinical Trial Results Ampyra (dalfampridine) Mode of Action

Current Status Approvals/Filings

Company Expertise

Forecast

Clinical Trial Results PHASE III

Alemtuzumab Mode of Action

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Company Expertise

Forecast

Clinical Trial Results MS Phase II

BG-12

Mode of Action Current Status

Company Expertise

Forecast

Clinical Trial Results Daclizumab

Mode of Action Current Status Approvals/Filings Development

Company Expertise

Forecast

Clinical Trial Results Laquinimod Mode of Action Current Status

Company Expertise

Forecast

Clinical Trial Results Teriflunomide Mode of Action Current Status

Company Expertise

Forecast

Clinical Trial Results PHASE II

ACT-128800 Mode of Action Current Status

Company Expertise

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BAF312 Mode of Action Current Status

Company Expertise

Firategrast Mode of Action Current Status

Company Expertise

Ocrelizumab Mode of Action Current Status

Company Expertise

Clinical Trial Results Ofatumumab Mode of Action Current Status Approvals/Filings Development

Proof of Concept/Clincal Data Development Risks

Company Expertise

Clinical Trial Results Perampanel Mode of Action Current Status

Company Expertise

METHODOLOGY

- Competitor Ratio Analysis Criteria - Drug Sales Forecasting

LIST OF TABLES:

Competitor Ratio Analysis Summary

Global MS Drug Sales, 2009-2016 (US$ Millions) Drugs in Clinical Development for MS

People with MS by Country and Region, 2010-2015

Prevalence of MS per 100,000 Population by Country & Region, 2010 Data Exclusivity

Patent Expiry

Copaxone Sales by Company (2008-2016) Patent Expiry

Avonex Sales (2008-2016)

Interferon Beta-1b Sales by Company (2008-2016) Rebif Sales (2008-2016)

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Patent Expiry

FDA ANDA Approvals for Mitoxantrone Tysabri Sales by Company (2008-2016) Gilenya Sales (2011-2016)

Movectro/Mylinax Sales (2011-2016) Data Exclusivity

Patent Expiry

Ampyra Sales (2010-2016) Patent Expiry

Campath Sales by Indication (2008-2016) BG-12 Sales (2012-2016)

Daclizumab Sales in MS (2012-2016) Laquinimod Sales (2012-2016) Teriflunommide Sales (2012-2016) LIST OF FIGURES:

Leading MS Products by Sales Value, 2009 (%) MS Market by Company, 2009 (%)

Leading MS Products by Sales Value, 2016 (%) MS Market by Company, 2016 (%)

Total Number of People with MS, 2007 Mean Age of Onset of MS, 2007

Geographic Spread of People with MS, 2010 (%)

Geographic Prevalence of MS per 100,000 Population, 2010 Copaxone Sales by Company (2008-2016)

Avonex Sales (2008-2016)

Interferon Beta-1b Sales by Company (2008-2016) Rebif Sales (2008-2016)

Tysabri Sales by Company (2008-2016) Gilenya Sales (2011-2016)

Movectro/Mylinax Sales (2010-2016) Ampyra Sales (2008-2016)

Campath Sales by Indication (2008-2016) BG-12 Sales (2012-2016)

Daclizumab Sales in MS (2011-2016) Laquinimod Sales (2012-2016) Teriflunomide Sales (2012-2016)

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