Strong sales for Biogen Idec’s MS drug
pharmafile | October 29, 2013 | News story | Sales and Marketing | Biogen IDEC, Q3, gilenya, tecfidera
Biogen Idec’s oral multiple sclerosis (MS) drug Tecfidera lived up to its blockbuster-in-waiting billing with third quarter sales that exceeded all expectations.
Tecfidera (dimethyl fumarate) has been tipped as a multibillion dollar drug since it was in late-stage development, and with sales of $286 million in the third quarter – only its second full quarter since launch in the US in March – it has got off to a strong start.
Despite being the third oral MS drug to reach the market after Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), Biogen Idec’s chief executive George Scangos told investors yesterday that: “Tecfidera is now the leading oral therapy after only six months on the market.”
Moreover, the strong performance of the oral MS treatment helped propel Biogen Idec’s revenues up 32% to $1.8 billion, and the growth of Tecfidera does not appear to have come at the expense of the company’s other MS drugs.
Sales of Avonex (interferon beta-1a) slipped marginally to $733 million – holding up well in the face of a higher level of competition in the marketplace with a gain in market share – while Tysabri (natalizumab) also performed well with sales up 46% to top $400 million in the quarter.
The latter drug’s increase was mostly due to Biogen assuming total control of the product from former marketing partner Elan Corp earlier this year.
Biogen Idec’s head of commercial operations Tony Kingsley, said that around 5,000 doctors had prescribed Tecfidera since launch and these account for most of the big prescribers for MS, so achieving long-term success for the drug “will require a robust and sustained commercial effort”.
“We expect new Tecfidera prescription volumes will remain healthy but … moderate to more closely reflect the underlying patient dynamics of the MS market,” he added.
Even if Tecfidera’s growth trajectory starts to slow, Biogen Idec could add to its MS franchise once again in the coming months if it secures approval for a long-acting pegylated interferon beta product called Plegridy (peginterferon beta-1a), which was submitted for approval in the US in May.
Tecfidera has also been approved in Australia and Canada, but a launch in Europe has been delayed while the company tries to resolve patent and regulatory data protection issues. The company was granted an EU patent earlier this year providing protection until 2018, but it is holding out for regulatory data protection which could make its patents harder to challenge.
Scangos was tight-lipped on progress with the data protection negotiations in the EU on the company’s third-quarter results call, and said only that the company was ‘working diligently’ on the topic.
Away from MS the picture was not quite so rosy, with Scangos revealing that approval of the company’s haemophilia A candidate Eloctate (recombinant factor VIII Fc fusion protein) has been delayed by negotiations with the FDA, relating to “validation of certain steps in the manufacturing process”.
Biogen Idec also raised its earnings guidance for the year to include 23%-25% revenue growth and earnings per share of $8.65-$8.85, up from $8.25-$8.50 predicted after its second quarter results.
Phil Taylor
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