) recently announced that the US Food and Drug Administration
(FDA) has approved Zortress (everolimus) for an additional
Zortress is now approved for the prophylaxis of organ
rejection in adults undergoing a liver transplant.
The approval was based on results from a phase III randomized
study, which was conducted in 719 liver transplant patients
starting 30 days post-transplant. The study spanned over 12
Zortress reported revenues of $210 million in 2012, up 20%
year over year driven by robust demand.
We note that Zortress is already approved in the US for the
prophylaxis of organ rejection in adult patients undergoing
The approval for the new indication makes Zortress the first
mTOR inhibitor approved to prevent organ rejection in adult liver
transplant patients in the US. We expect that the recent approval
will further boost Zortress sales.
We remind investors that everolimus was approved by EU for use
in adult liver transplant patients in the fourth quarter of 2012
under the trade name Certican.
Certican is already approved in more than 90 countries namely
Chile, Philippines and Argentina to prevent organ rejection for
renal and heart transplant patients. In most EU member countries,
Certican is also approved in kidney and heart
Novartis has also licensed Zortress to
) and sub-licensed to Boston Scientific for use in drug-eluting
Currently, Novartis carries a Zacks Rank #3 (Hold). Large-cap
pharma companies that currently look better-positioned include
). Both are Zacks Rank #2 (Buy) stocks.
ABBOTT LABS (ABT): Free Stock Analysis Report
BAYER A G -ADR (BAYRY): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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