* Patient took Novartis' Gilenya MS pill
* Developed progressive viral disease
* First incidence in 71,000 patients
* Gilenya facing competition from Biogen's Tecfidera
ZURICH, July 30 A patient taking Novartis'
multiple sclerosis pill Gilenya developed a rare and
potentially fatal viral disease, the Swiss drugmaker said on
Tuesday, an unexpected setback as it faces growing competition
from new oral treatments.
Gilenya is one of Novartis' big new drug hopes, growing 66
percent in the second quarter to $468 million. But the drug
faces competition from new medicines such as Biogen Idec's
Novartis said it had been informed of a case of progressive
multifocal leukoencephalopathy (PML) in a patient who had been
taking Gilenya for MS for seven months.
It said it was working with the reporting physician to
understand all possible contributing factors, including those
beyond treatment, given several atypical features of the case.
"The course of the underlying neurological disease was rapid
with some atypical findings for MS on the MRI scans of the brain
and spinal cord, as well as some unusual clinical features,"
Novartis said in a statement.
Novartis said all previously reported cases of PML among the
approximately 71,000 patients treated with Gilenya thus far had
been attributed to prior treatment with Biogen Idec's Tysabri,
which bears a known risk of PML.
Deutsche bank analyst Tim Race said the case may provoke
some concerns about Gilenya's future growth potential. But he
noted the incidence of reported PML cases for Gilenya has so far
been extremely low.
"By the time there was a similar level of patient experience
with Tysabri there had been 298 cases reported. Thus, even if
the risk proves to be real it is likely to be of a very
different order of magnitude," Race said in a note.
Shares in Novartis were trading down 0.8 percent at 66.10
Swiss francs by 0904 GMT, compared to a 0.4 percent weaker
European healthcare sector.