Positive Data on Vertex' Incivek - Analyst Blog
June 24 2011 - 5:00AM
Zacks
Vertex Pharmaceuticals
Inc. (VRTX) recently reported data from two late stage
trials – ADVANCE and REALIZE – on Incivek (telaprevir). The data
were published in the June edition of the New England Journal
of Medicine.
The trial results demonstrated that
when patients suffering from chronic hepatitis C (HCV) were given
Incivek combination therapy, they experienced significant
improvement in sustained viral response (SVR) rates, as compared to
those who received pegylated-interferon and ribavirin alone.
In the ADVANCE study, Incivek
combination therapy demonstrated the aforesaid results in new
patients, while the REALIZE study consisted of treatment-failed
patients.
We note that in the ADVANCE study,
majority of the patients treated with Incivek combination therapy
completed the treatment in 24 weeks, which is half the time needed
in the pegylated-interferon and ribavirin arm. Further, in the
REALIZE study, the SVR rates were three-to-six-times higher in the
Incivek arm compared to the pegylated-interferon and ribavirin
arm.
Incivek was approved by the US Food
and Drug Administration (FDA) last month as a treatment for HCV, in
both treatment-naïve and treatment-failed patients. The drug is
currently under regulatory review in the European Union and Canada.
A response from the European regulatory body is expected in the
second half of 2011.
Vertex Pharma has exclusive US
commercialization rights to Incivek and has joined hands with
Johnson & Johnson (JNJ) and Mitsubishi Tanabe
Pharma for the commercialization of the drug outside the US. While
Johnson & Johnson is responsible for the commercialization of
Incivek outside North America and the Far East, Mitsubishi Pharma
will market it in certain areas of the Far East including
Japan.
Vertex Pharma faces competition for
Incivek from Merck & Co.'s (MRK) Victrelis
(boceprevir), a similar protease inhibitor molecule, which was
approved by the FDA recently. The drug has also been recommended
for approval by the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA).
Meanwhile, companies like
Boehringer Ingelheim, Gilead Sciences Inc. (GILD)
and Roche Holdings Ltd. (RHHBY) have pipeline
candidates for the treatment of HCV.
We currently have a Neutral
recommendation on Vertex Pharma, which carries a Zacks #3 Rank
(short-term Hold rating).
GILEAD SCIENCES (GILD): Free Stock Analysis Report
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VERTEX PHARM (VRTX): Free Stock Analysis Report
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