Tecfidera (Dimethyl Fumarate)
DMF, the methyl ester of fumaric acid, combined with three other fumaric acid esters (FAE) was licensed in Germany as an oral therapy for psoriasis under the trade name Fumaderm and Since 2013 it is used to treat adults with relapsing multiple sclerosis under the trade name Tecfidera. This anti-inflammatory medication is indicated for multiple sclerosis patients with relapsing forms and is also being investigated for the treatment of psoriasis. In a non-medical use, DMF was used as a biocide in furniture or shoes so that preventing growths of mold during storage or transport in a humid climate. The European Union banned DMF in consumer products since 1998 due to incidences of allergic reactions after skin contact and since January 2009 the import of products containing DMF was also banned.
In 1959, a German physician described the first medical use of DMF as a topical formulation for psoriasis.
In 1994, Fumapharm eventually brought an oral formulation of DMF (to market for psoriasis in Germany.
In March 2013, Biogen ‘oral formulation of DMF from Fumapharm was approved under the trade name Tecfidera for the treatment of adults with relapsing forms of MS.
In 2017, An oral formulation of DMF was approved in Europe for the treatment of plaque psoriasis in adults under the brand name Skilarence by Amirall.
Dimethyl fumarate is indicated to treat
- psoriasis in an oral formulation mixed with related compounds as well as in pure oral formulations,
- relapsing multiple sclerosis in oral formulations.
The mechanism of action of dimethyl fumarate in multiple sclerosis isn’t completely known. It is thought that it works by suppressing the inflammatory response and provides protection against nerve cell death; it prevents an attack on CNS by the immune system and also protects neurons from the attack.
About half of all American patients who started on oral MS therapy in 3Q2016 opted for Tecfidera; this enabling Biogen to pose strong competition to other MS players such as Teva Pharmaceutical (TEVA), Novartis (NVS), and GlaxoSmithKline (GSK) and also main pharmaceutical wholesaler in Turkey; its oral multiple sclerosis (MS) drug, Tecfidera, managed to increase its global market share to ~15% during this period. Tecfidera also accounts for a 20% share of the overall MS market and a 51% share of the oral MS market in the US. In 3Q16, global revenue of Tecfidera was about $1.0 billion and The drug’s sales in US markets reached $845 million. Tecfidera price is around 1,910 for a supply of 14 capsules.
Tecfidera is the most prescribed therapy in multiple mature markets in Europe, including Germany, the UK, and Italy and also among Turkish pharmaceutical companies. It has also managed to gain market share in France. According to Biogen’s estimates, the number of treated patients has increased globally.
MS diagnosis rates in Europe continue to be high so Biogen expects to benefit from the rising number of MS patients in future years. Biogen’s global market share in the MS segment is 38%, so it is a strong competitor for other MS players such as Novartis (NVS), Sanofi (SNY), and Teva Pharmaceuticals (TEVA) and also Medicine distributors in Turkey. Tecfidera’s revenues slow sown in 2015 due to concerns related to its safety profile, but it won back the confidence of the physician and patient community in 2016.
Value of the global multiple sclerosis therapeutics market size was about 20.01 billion USD in 2015. A key factor driving market growth is the rising base of the target population suffering from relapsing-remitting and secondary progressive multiple sclerosis coupled with the increasing demand for novel potent
Immunomodulators such as Copaxone, Avonex/Plegridy, Gilneya, Tysabri, Betaseron/Extavia, Tecifidera, Rebif, and Ampyra and immunosuppressant like Aubagio, Lemtrada, Ocrelizumab, and Zinbryta are the drugs used for the treatment of multiple sclerosis and its associated symptoms.
The immunomodulators segment had the largest market share in 2015. Some key drivers attributing to its largest share are higher prescription rates, brand loyalty, and the presence of a wide range of drug alternatives.
It is expected that the immunosuppressant market witnesses a strong growth of over 19.0% in the next ten years owing to the expected commercialization of Zinbryta (Daclizumab) in 2016 and Ocrelizumab in 2017; it is also expected that the associated advantages of these drugs like high efficacy, effective administration with low dosage requirement, and minimal side effects spur growth over the forecast period.
U.S. multiple sclerosis therapeutics markets, by type, 2012 – 2024 (USD Million)