ViewPoints: Biogen Idec moves swiftly to allay Tecfidera safety concerns – key opinion leaders in agreement

On Thursday, Biogen Idec delivered a positive Q1 conference call revising guidance upwards with revenue growth for the full year expected at between 16 percent and 18 percent; Tecfidera – poised to become the market leading multiple sclerosis treatment – is expected to act as the company's key sales growth driver. However, on the same day, Biogen Idec was forced to bat away recent suggestions that the newly-approved MS tablet is associated with cases of progressive multifocal leukoencephalopathy (PML).

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In letters published in the NEJM on Wednesday, it was highlighted that Fumaderm, a compounded version of dimethyl fumarate (the same active ingredient in Tecfidera), which is also manufactured by Biogen Idec and used to treat psoriasis in Germany, has been linked to a number of PML cases.

One analyst – who wished to remain unidentified – told FirstWord that the cases have been in the public domain for some time, but the timing of the letters to the NEJM (a day before Biogen Idec released its Q1 results) was perhaps "somewhat suspect."

Biogen Idec, note a number of analysts, has fully disclosed the link to PML in the past and during the company's Q1 conference call on Thursday, CEO George Scangos told investors and analysts that the disclosures were both "old news" and "misinformation." On Wednesday, Biogen Idec reiterated that Tecfidera had been used in over 2,600 patients, some of whom have been receiving the drug for over four years, with no reported cases of PML. Previously it has cited that three cases of PML have occurred in over 180,000 patient years of Fumaderm use.

FirstWord's own interviews with key opinion leaders in the MS field support this view and paint the picture of a drug that is not only viewed as being highly effective, but one with a benign safety profile (a view echoed by the FDA, which approved Tecfidera with a clean safety label). Patrick Vermersch – who works in the Department of Neurology at the University of Lille - told FirstWord earlier this month that Tecfidera "is a new generation of fumarate derivatives and we know for maybe two or three decades in Germany this family of drugs are safe, I think, because the drug was used in Germany for 30 years, approximately. And we have no bad feelings concerning the safety."

Credit Suisse analyst Ravi Mehrotra also subscribes to this school of thought, and, in a note to investors published on Thursday, reiterated his view that Tecfidera will "drive a paradigm shift in the treatment of multiple sclerosis," but to "completely ignore the NEJM articles would be overly dismissive." The headline news is not new, adds Mehrotra, but the granularity and mass distribution of this news is.

Despite suggestions that very early uptake of Tecfidera is strong (see ViewPoints: Very early (one week) prescription data demonstrates rapid uptake for Biogen Idec's Tecfidera), Mehrotra cites the general slow-uptake of new therapies in the MS space, an inherent fear among community physicians regarding "all things immunosuppressive and PML related" and the articles being published in the highly respected NEJM, as key reasons why competitor companies may be able to leverage this news to counter detail Biogen Idec's growth-driver in waiting. As a result there will be added interest in early prescription trends for the would-be blockbuster.

See also:

Spotlight On: Five key facts about Biogen Idec's Tecfidera

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