Mixed news for Biogen Idec on Tysabri
pharmafile | April 27, 2009 | News story | Manufacturing and Production |Â Â BiogenÂ
Biogen Idec has won approval for a new high-titre manufacturing process for its multiple sclerosis product Tysabri (natalizumab) which should boost yields by up to four times.
The new manufacturing process will reduce the cost of goods for Tysabri and help meet demand for the drug, which saw sales advance more than 130% last year to $813 million on the back of data showing that the drug may be able to halt disease progression and even improve physical disability in some patients.
Biogen Idec said the new production process would shortly be implemented at its facility in Research Triangle Park in the US. The company also won a green light from European regulatory the EMEA to start up the high-titre process in December 2008.
Slowdown in growth?
While the approval is good news for Biogen Idec, some concerns are starting to creep in about Tysabri's future sales growth.
Biogen Idec and partner Elan recently reported a sixth case of progressive multifocal leukoencephalopathy (PML) – the serious viral infection that led the product to be suspended from the market between 2005 and 2006.
Analysts are starting to wonder whether some of the drug's momentum is starting to slip away.
Worldwide sales of Tysabri were $227m in the first quarter of 2009, with $116m coming from the USA and $111m from overseas market, but were lower than many analysts' estimates to the tune of $15 to $20m.
Biogen Idec said the slowdown was partly a result of growing unemployment – which means that a higher proportion of patients get access to Tysabri for free – as well as a decline in the number of infusions received per patient.
Morningstar analyst Karen Anderson is concerned the latter could be evidence of patients skipping doses in the hope of reducing their risk of side effects.
"We think it's unclear whether the reduction in the number of infusions is related to patients trying to save out-of-pocket costs by lengthening the time between infusions, or whether some patients are taking a 'holiday' from treatment," she said.
Biogen Idec currently has over 40,000 patients on commercial and clinical Tysabri therapy and approximately 6,800 patients who have been on therapy for over two years. The average therapy duration before onset of PML in the cases to date is 19 months.
The company maintains that taking drug holidays is likely to decrease the benefit/risk profile of Tysabri, as there is evidence that – in the majority of patients – disease activity returns rapidly on cessation of the drug. However, to prove or disprove this risk reduction would require a two-year study with around 150,000 patients, it said recently.
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