Vertex Pharmaceuticals Incorporated
(
VRTX
) recently announced the approval of its cystic fibrosis (CF)
treatment, Kalydeco, in Canada. Kalydeco gained approval for the
treatment of cystic fibrosis in patients aged 6 years and older
who have at least one copy of the G551D mutation in the cystic
fibrosis transmembrane conductance regulator (CFTR) gene.
Kalydeco is already approved in the US and the EU. While US
approval came in January, EU approval was granted in July. Vertex
Pharma reported Kalydeco sales of $49.2 million in the recently
reported third quarter of 2012. Vertex Pharma is currently
working on the EU launch of Kalydeco. The company expects
reimbursement coverage in each of the four major European
countries that account for 80% of the G551D patients in Europe in
2013.
Vertex Pharma reported 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
which could expand the target population from the current 4% to
approximately 15% of CF patients. Vertex Pharma also remains on
track to commence pivotal studies in early 2013 with Kalydeco
plus VX-809 in delta 508 homozygous patients.
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
(
JNJ
) to commercialize Incivek outside the US.
Neutral on Vertex Pharma
We currently have a Neutral recommendation on Vertex Pharma,
which carries a Zacks #4 Rank (Sell). Vertex Pharma's third
quarter results were disappointing with both earnings and
revenues missing expectations. We expect Incivek sales to
continue being affected by warehousing and a slowdown in new
patient additions. Meanwhile, Kalydeco sales should pick up from
2013 when additional launches take place in the EU. With the
company working on expanding Kalydeco's label and strengthening
its HCV portfolio, we expect investor focus to remain on pipeline
progress.
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