Biogen Idec (BIIB) and Elan Corporation, plc (ELN) recently announced that they have started enrolling patients for a phase IIIb head-to-head study between Tysabri and Teva Pharmaceuticals’ (TEVA) Copaxone and Merck Serono/Pfizer’s (PFE) Rebif.
The randomized, rater-blinded, active-controlled study (SURPASS) will evaluate the efficacy of Biogen/Elan’s Tysabri in patients with relapsing remitting multiple sclerosis (RRMS) who switch to the drug from other treatments like Copaxone or Rebif.
With a considerable number of MS patients relapsing or showing signs of disease progression despite being treated with therapies like Copaxone and Rebif, the trial will study whether the early use of Tysabri could result in better outcomes compared to staying on current therapy or switching between Copaxone and Rebif.
The study, which will be conducted with 1,800 patients across 27 countries, will also evaluate the safety and tolerability of switching to Tysabri. Favorable results from this study would be a major boost for the product as it would lead to patients switching from Copaxone/Rebif to Tysabri.
Biogen/Elan’s Tysabri is currently approved in more than 45 countries. Despite carrying a “black box” warning for the risk of progressive multifocal leukoencephalopathy (PML) and other cautionary language, Tysabri sales crossed $1 billion in 2009.
However, we note that the number of new patients adopting the product has been declining over the past few quarters. Additional instances of PML cases could hamper the product’s acceptance in the medical community, thereby limiting its sales growth.
Earlier this year, the US Food and Drug Administration (FDA) issued a notice on its website regarding the risk of developing PML with increased use of Biogen/Elan’s Tysabri.
The prescribing information on the product’s label has since been updated to include information regarding the increased risk of developing PML increases with longer use of the product. The label also includes language regarding limited experience beyond 3 years of treatment.
With Tysabri being an important growth driver for Biogen, we remain concerned that an increase in the number of PML cases associated with its use could lead to a slowdown in its sales going forward. We currently have a Neutral recommendation on Biogen.
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