Vertex Pharmaceuticals Inc.
) recently announced that the Health Service Executive (HSE) in
the Republic of Ireland has agreed to fund its cystic fibrosis
(CF) drug Kalydeco (ivacaftor). Kalydeco is the first medicine to
be approved for the treatment of the underlying cause of CF in
patients (aged 6 years or above) who have at least one copy of
the G551D mutation in the CF transmembrane conductance regulator
Kalydeco is already approved in the US and the EU. While the
US approval came in Jan 2012, the EU approval was granted in Jul
2012. Vertex Pharma reported Kalydeco sales of $171.6 million in
2012. The company expects Kalydeco revenues in the range of
$280-$320 million in 2013.
Vertex Pharma is currently working on the EU launch of
Kalydeco. Vertex expects first quarter 2013 Kalydeco revenues to
be similar to the fourth quarter 2012 level. Kalydeco revenues
should start growing from the second quarter with the completion
of reimbursement discussions in EU countries.
Currently, Vertex Pharma has another marketed product in its
portfolio: Incivek, which is approved for the treatment of
hepatitis C virus (HCV). Vertex Pharma has an agreement with
Johnson & Johnson
) to commercialize Incivek outside the US.
Vertex Pharma reported during its fourth quarter conference
call that it is now treating most of the eligible G551D patients
in the US. The company is working on expanding Kalydeco's label
and is conducting monotherapy studies to expand the target
population of CF patients. Vertex Pharma also remains on track to
commence pivotal phase III development soon with Kalydeco plus
VX-809 in delta 508 homozygous patients.
The company is also looking to strengthen its hepatitis C
virus (HCV) portfolio. We expect investor focus to remain on
pipeline progress at Vertex Pharma.
Vertex Pharma currently carries a Zacks Rank #3 (Hold). Pharma
companies that currently look more attractive include
). While Medivation carries a Zacks Rank #2 (Buy), Targacept
carries a Zacks Rank #1 (Strong Buy).
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