2. Therefore, the active substance of Tecfidera, dimethyl fumarate, is a new active substance. This conclusion is based on the review of the scientific evidence, and in line withclarification provided by the European Commission that:
Tecfidera MA on 30 January 2014..........10 yrs from this date
Biogen Idec has won regulatory protection for its top-selling multiple sclerosis drug Tecfidera in Europe, paving the way for its launch in markets that could account for a large proportion of future sales.
The European Medicines Agency said on Friday it had granted the oral medicine a "new active substance" (NAS) designation, securing Biogen 10 years protection through data exclusivity that will stop generic firms from launching copycat versions.
In March, Tecfidera was approved in the United States and also recommended for approval in Europe - but its EU launch has been delayed, pending a resolution of uncertainty over data protection.
Without this protection, Biogen would have to rely on relatively weak patents relating the drug's use, which analysts believe might not prevent generic rivals launching cheaper copies in key markets like Germany.
Tecfidera was recommended on 25 March by Europe’s Committee for Medicinal Products for Human Use (CHMP) as a known active substance, rather than a new active substance. A Biogen spokesperson said it was entitled to 10 years’ exclusivity for Tecfidera in the EU under the “Independent Development” principle and its stand-alone data package. The EMA’s guidance on exclusivity will be announced when the final approval decision is given.
If Tecfidera is not granted exclusivity through new active substance status or the Independent Development principle, Biogen will only have patent protection in the EU rather than protection against competitors using its MS data for generic regulatory filings of Tecfidera. The company’s latest EU patent (EP 1131065) expires in 2019 and is directed to formulations of dimethyl fumarate and its uses for autoimmune diseases including MS, according to company documents.
- dimethyl fumarate
The proverbial thorn in Biogen Idec’s paw is a little used product called Fumaderm – which is approved in Germany for the treatment of psoriasis. A ‘chemical cousin’ of Tecfidera (Fumaderm is a compounded form of dimethyl fumarate – the active ingredient in Biogen Idec’s new MS treatment), Fumaderm generated sales of just $60 million in 2012 – a figure that Tecfidera is expected to surpass during its first three months of availability in the US market alone.
The similarities between Tecfidera and Fumaderm would appear to have guided Biogen Idec away from the pursuit of new active substance (NAS) status for Tecfidera – which ordinarily provides new product approvals a minimum of eight years data exclusivity and two years market exclusivity
Biogen Idec wins EU battle on Tecfidera exclusivity
Oral MS drug gains New Active Substance status
Biogen Idec has delayed the introduction of Tecfidera in Europe while the matter was resolved, and can now move ahead with a launch, secure in the knowledge that it has gained 10 years of regulatory exclusivity for the fast-growing product.
Tecfidera was approved in the US in March, becoming the third orally-active MS treatment to reach the market after Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide), and has romped away in its first few months on the market, racking up around $500m in sales in its first six months.
The drug was awarded a European patent on May 29 that protects it from generic competition until 2028, but has also been pushing for regulatory data protection and NAS status, which will confer an additional level of protection against patent challenges.
Biogen Idec said in a statement that Tecfidera's EU approval has been delayed while the regulatory status of the drug is resolved, but now - with a CHMP positive opinion already in the bag - it can now be referred to the European Commission for a final ruling on the marketing application.
"We are ready to introduce Tecfidera in EU countries shortly after anticipated approval," said the company's executive vice president of R&D Douglas Williams.
Analysts have predicted that the drug could lead the market for oral MS therapies as they become established in favour of injectable interferon-based treatments, with sales of $3bn-a-year or more in 2016.
FUMADERM An oral preparation containing dimethyl fumarate and monoethyl fumarate salts