A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market

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1 A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market Launch of Several Pipeline Oral Products Could Diminish the Market for Injectable Therapies NEC3-52 November 2014

2 Contents Section Slide Number Executive Summary 4 Recent Market Developments 6 Defining Healthcare Trends in the Future 8 Companies to Watch 10 Methodology and Scope 11 Introduction 13 Market Overview Segmentation 15 Market Background 18 Prevalence of Multiple Sclerosis in Major Markets 19 Physician Guideline to Multiple Sclerosis Therapy 21 Competitive Landscape 22 Profiles of Launched and Late Stage Investigational Products 42 Conclusions and Recommendations 58 The Frost & Sullivan Story 61 NEC3-52 3

3 Key Findings The number of MS prevalent cases globally (10 Million) is predicted to increase from in 2013 to by The United States MS market is entering a new phase of growth that is driven by the development of innovative therapeutic platforms. Recent therapeutics advances focus on a couple of factors: o Improving tolerability of existing products specifically for interferon beta and glatiramer acetate o Development of anti-inflammatory medications o More clinical studies done investigating treatments in progressive MS o Many clinical studies now include effects of Vitamin D in relapsing MS The existing interferon therapies Avonex, Rebif, Betaseron/Extavia, and Plegridy, along with novel therapies such as Copaxone, Tysabri, Novantrone, Gilenya, and Tecfidera have helped build a patient base in a market that has a very high degree of unmet medical needs. Oral therapies are revolutionizing the treatment paradigm of MS by improving dosing and patient compliance. Biogen s Tecfidera, in particular, has been a game changer in the US MS market, stealing shares from older therapies. Newer treatments have the potential to treat refractory MS patients as well as patients suffering from primary progressive MS (PPMS). There is significant interest from big pharmaceutical, biotechnology, and specialty pharmaceutical companies to enter or expand their position within the market. Source: Globaldata.com; Frost & Sullivan NEC3-52 5

4 Recent Market Developments Multiple Sclerosis Therapeutics Market: Recent Developments, Global, Date Category Description September 2014 Partners Biogen Idec and AbbVie have met its primary and secondary end-points in its Phase III trials. The partners are planning on filing for Food and Drug Administration (FDA) and European approval in the first half of August 2014 New Drug Launch Biogen Idec s Plegridy received FDA approval. August 2014 Forward Pharma plans on beginning a late-stage trial testing of FP187 against RRMS later this year. After an additional investment of $ million or so on preclinical assets, Forward Pharma expects to launch a Phase III psoriasis study on the drug in June 2014 Biogen and Abbvie announce positive top-line results from the Phase III DECIDE clinical trial. NEC3-52 6

5 Recent Market Developments (continued) Date Category Description June 2014 May 2014 March 2014 Regulatory RPC1063, a drug formulated by Recepto Inc, is in a Phase III clinical trial. Patients responded with an % reduction in brain lesions for both doses that were studied. Sanofi has resubmitted Lemtrada for FDA approval after consistent rejection from the agency. Alkermes s ALKS 8700 is a novel drug undergoing a 125 patient Phase I trial designed to convert to monomethyl fumarate in the body and relieve MS symptoms. November 2013 New Drug Launches Biogen set the stage for Tecfidera s launch in Europe. September 2013 November 2013 New Drug Approvals Sanofi received EU approval for two of its MS drugs, Aubagio and Lemtrada. However, it gets mixed FDA reviews for the drug Lemtrada, concluding that it cannot be used as first-line MS therapy. NEC3-52 7

6 Defining Healthcare Trends in the Future Is your company prepared for the challenging market that lies ahead? Multiple Sclerosis Therapeutics Market: Market Outlook, Global, 2014 and 2024 Topic Present (2014) Future Outlook (2024) Regulation/ Clinical Trials Risk/Cost The FDA, even though it does not require placebos in clinical trials, strongly recommend it. This plays into the difficulty in recruiting patients because no patient wants to be on a placebo when there are numerous other MS clinical treatment offered. Drug development for MS indications is a very high risk venture due to the sizeable time and financial investment necessary to demonstrate clinical benefit. Many drugs have failed only after very large Phase II or III trials. The FDA is expected to become much more strict by 2021 to 2022 and will likely only approve RRMS treatments that slow disability. They will be placing a higher emphasis on this based on a risk-benefit profile. The MS disease is so variable which is why the chances and the cost of failures are so high. The data is very subjective, which can lead to inconclusive or deviant data. An approach must be developed to standardize these trials and treatment. Potentially having sub-studies with the inclusion of an MRI could produce better data. NEC3-52 8

7 Defining Healthcare Trends in the Future (continued) Topic Present (2014) Future Outlook (2024) Long-term Clinical Trials A major market issue still remains that physicians and the public do not have knowledge of the long-term safety of any of the new MS drugs. There is a vital need in the market for long-term studies done on future and existing products. Many pharmaceutical companies are aware of this growing need and see the necessity in investing in long-term studies for their drugs. The next generation of drugs will have long-term studies associated with them. This could potentially spur pharmaceuticals to develop low-risk drugs for the treatment of MS. Market Focus RRMS is the largest segment of the MS market, especially in the US and EU regions. However, there is a huge unmet need for therapeutic drug development in the PPMS segment. To reach this untapped market, more research will be done in this field to achieve greater understanding of the disease pathology. There is already research indicating that there are significant effects of different lifestyles on RRMS and PPMS with regards to onset of disabilities. This information is vital for a large population set. NEC3-52 9

8 Companies to Watch Forward Pharmaceutical Biotech company based in Denmark developing immunomodulatory compound dimethyl fumarate and derivatives for the treatment of MS Currently in Phase III with an MS drug and is hoping to be direct competition to Biogen Idec s Tecfidera in the European market Recepto Inc. A biopharmaceutical company based in California that is developing an oral therapy for relapsing forms of MS The drug RPC1063 is in Phase III trials in the United States, is looking to compete with the market giant Novartis and their drug, Gilenya Alkermes Company headquartered in Ireland and is developing ALKS 8700, which is in Phase I trials Is designed to convert to monomethyl fumarate in the body, relieve MS symptoms, and plans on competing with Tecfidera in the European and US market NEC

9 Methodology and Scope This research service focuses on prescription drugs used to treat MS. A product and pipeline assessment is provided for marketed and investigational drugs for the treatment of MS. Segmentation by drug class is provided, along with additional supporting information such as clinical trial timelines and results, projected launch timelines, and epidemiology. The information contained in this research service was derived from published sources, including disease organization Web sites; public health organization Web sites; company publications including annual reports, SEC filings, and press releases; government public sources; and published articles in scientific journals. NEC

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