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EU Approval for Novartis' Exjade - Analyst Blog

By: Zacks.com
Posted: 12/27/2012 4:52:00 PM
Referenced Stocks: CHMP;JNJ;NVO;NVS

Switzerland based Novartis ( NVS ) recently announced the approval of Exjade (deferasirox) by the European Commission. 

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 Agency (EMA).

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 disease increases. 

However, patent protection for the active ingredient in Exjade will expire in 2019 in the US and in other markets in 2021. 

Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold) in the short run. However, other pharma companies like Novo Nordisk ( NVO ) and Johnson & Johnson ( JNJ ) carry a Zacks #3 Rank (Hold).



JOHNSON & JOHNS (JNJ): Free Stock Analysis Report

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