) recently announced the approval of Exjade (deferasirox) by the
Exjade has been approved for the treatment of chronic iron
overload requiring chelation therapy when treatment with
deferoxamine is contraindicated or is inadequate in patients aged
10 years and above who have been suffering from
non-transfusion-dependent thalassemia (NTDT) syndromes.
With this approval, Exjade is the first oral treatment to be
approved in the EU for the treatment of chronic iron overload in
patients suffering from NTDT syndromes.
Exjade's approval did not come as a surprise as in Nov 2012,
it had received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Approval was based on results from the THALASSA study, which
showed a significant dose-dependent decrease in iron content
compared to placebo. The study also revealed that Exjade was well
tolerated, with the overall adverse event rate being similar to
that of placebo.
First approved in 2005, Exjade is now approved in more than
100 countries, including the US, EU and Japan. Exjade generated
sales of $850 million in 2011, up 12% year over year driven by
strong growth based on new patients and expansion into major
geographies like Asia and Europe.
Exjade was one of the top ten selling brands for Novartis in
2011. As per current published studies, approximately three
quarters of a million people worldwide have NTDT syndromes and
this number is expected to rise further as awareness of the
However, patent protection for the active ingredient in Exjade
will expire in 2019 in the US and in other markets in
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold) in the short run.
However, other pharma companies like
Johnson & Johnson
) carry a Zacks #3 Rank (Hold).
JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
To read this article on Zacks.com click here.