Sanofi’s multiple sclerosis entrants set to join a rapidly expanding market

Analysis

A second European approval in as many months for Sanofi’s growing multiple sclerosis franchise gives the French drugmaker a firmer footing in a market that analysts see growing at 9% a year to $21.3bn by 2018.

Financial analysts have been taking an increasingly optimistic view of the prospects for these drugs – the new wave of disease-modifying MS treatments that have reached the market in recent years has seen substantial sales forecast upgrades in the past 12 months, EvaluatePharma data show. It seems likely that huge expectations for Tecfidera, Biogen Idec’s oral contender, has helped fan the flames of optimism elsewhere – consensus for sales of this drug in 2018 has grown by 24% since this time last year to a huge $4.43bn, despite ongoing concerns about European launch (see tables).

MS market – main products 2008-18 (ranked on 2018 sales) Annual MS sales WW ($m)
Product Company Pharmacology class 2008 2012 2014 2016 2018 Status First launch
1 Tecfidera Biogen Idec Nrf2 pathway activator - - 1,526 3,080 4,433 Marketed 2013
2 Gilenya Novartis S1P receptor modulator - 1,195 2,203 2,694 2,948 Marketed 2010
3 Tysabri Biogen Idec Anti-VLA-4 MAb 810 1,310 1,844 2,082 2,273 Marketed 2004
4 Avonex Biogen Idec Interferon beta 2,203 2,913 2,733 2,389 2,062 Marketed 1996
5 Rebif Merck KGaA Interferon beta 1,956 2,433 2,332 1,974 1,692 Marketed 1997
6 Copaxone Teva MS agent 2,262 4,027 3,567 2,218 1,367 Marketed 1996
7 Aubagio Sanofi PDGF & DHODH inhibitor - 9 307 637 859 Marketed 2012
8 Betaseron Bayer Interferon beta 1,681 1,564 1,214 978 651 Marketed 1993
9 M356 Novartis [Copaxone generic] - - 901 1,025 622 Filed 2014
10 Lemtrada Sanofi Anti-CD52 MAb - - 152 402 569 Filed 2013
Total market (incl other products) 8,948 14,168 18,077 20,022 21,313 9% CAGR

The official EU nod for Lemtrada today followed approval of Aubagio last month and, while these are not projected to become dominant market players, analysts reckon that by 2018 the two products will be generating combined sales of more than $1bn.

Approval of Aubagio in Europe came with a sting in the tail – the surprise decision to refuse the compound new active substance designation opened the possibility of generic competition as soon as 2016 – althopugh Sanofi did have this overturned on appeal this decision.

Biogen will be hoping to repeat this trick given its headaches in Europe with Tecfidera, which is similar to the psoriasis drug Fumaderm, a compound that has long been on the market. Approval of Biogen's candidate in Europe is on hold while the company attempts to secure 10 years' exclusivity, and it is unclear when this will be resolved (Generic equivalence lies at the heart of Tecfidera’s worst fears, June 13, 2013).

In a worst-case scenario Biogen might choose not to launch in Europe, where analysts reckon the opportunity could be equal to about 40% of peak sales. However this potential stain on the product’s future is failing to dent enthusiasm, given the hugely successful US launch. Second-quarter sales reached $192m – the drug was approved at the end of March – and prescription data point to substantial demand. Sales forecasts continue to edge higher, and since approval consensus for 2018 has risen 17%.

Future shape

The table below shows that analysts see this drug doing more than any other to grow the MS market. In clinical studies Tecfidera demonstrated a substantial improvement in relapse rates and disability progression, surpassing other oral products and most other injected treatments, and placing the drug as a front-line option.

Tysabri, Biogen’s antibody therapy for MS, is still widely considered an incredibly effective drug at preventing the relapses that haunt sufferers of the disease. Its association with the brain infection PML rules it out as a first-line option for many, although as its risks have been quantified in the last few years it has established itself as an essential option. In fact this consensus pegs it as the third-biggest MS drug in 2018.

Novartis’s Gilenya was the first oral pill to be launched for MS, in 2010, and despite perceived weaker efficacy compared with Tecfidera it is expected to remain a key player. It has also grappled with reports of PML; Novartis reported in July that a patient who had been taking the drug for seven months had developed the potentially fatal infection, the first seen in a patient who had not previously taken Tysabri. Cases remain extremely rare and seem unlikely to temper growth – the main drag will be competition from the Biogen pill.

In fact it seems likely that the future of the MS market – for the next few years at least – will largely be shaped by Tecfidera. The drug is seen as taking share from Gilenya and Copaxone, the Teva therapy that has been around for more than 15 years, and from the interferon class where reimbursement rules will allow.

Should European regulators rule against Biogen, the European market could end up looking very different from the US. Gilenya and Sanofi’s new entrants stand to benefit should this come to pass. But with huge expectations attached to this market, the launches of Tecfidera, Aubagio and Lemtrada will be closely tracked over the coming years.

MS market growth drivers
Product Company 2018 forecast sales ($m) CAGR 2013-18 Change in sales 2013-18 ($m) 12-mth chg in 2018 forecast Status
Tecfidera Biogen Idec 4,433 53% +3,909 24% Marketed
Gilenya Novartis 2,948 10% +1,096 37% Marketed
Aubagio Sanofi 859 38% +689 37% Marketed
Lemtrada Sanofi 569 71% +530 45% Approved

To contact the writer of this story email Amy Brown in London at AmyB@epvantage.com or follow @AmyEPVantage on Twitter

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