Novartis AG NVS announced that the FDA has approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade tablets, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older along with chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older.
We note that the FDA had approved Jadenu under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. However, continued approval for this indication may be subject to verification and description of clinical benefit in confirmatory trials.
Meanwhile, Novartis has submitted additional regulatory applications for Jadenu in other countries.
We note that Novartis’ Exjade is approved both in the U.S. and EU.
Jadenu tablets simplify administration of treatment for chronic iron overload as they can be consumed with or without a light meal, while Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach.
Exjade sales came in at $926 million in 2014, up 6% from 2013. However, the drug might face generic competition soon in the U.S.
Separately, Novartis entered into a multiyear alliance with Aduro Biotech for the discovery and development of next-generation cancer immunotherapies targeting the STING (Stimulator of Interferon Genes) pathway.
Per the terms of the agreement, Novartis will make an upfront payment of $200 million to Aduro and an initial equity investment in the company for $25 million along with another $25 million equity investment at a future date.
While Aduro will lead commercialization activities and book sales in the U.S., Novartis will be responsible for leading commercialization and recognizing sales in the rest of the world. Both companies will share profits from the U.S, Japan and major European countries, while Novartis will pay Aduro a royalty for sales in the rest of the world.
We remind investors that Novartis undertook a series of actions to reorganize its portfolio in 2014 in order to focus on its core businesses of pharmaceuticals, eye care and generics. The company is expected to face challenging conditions in 2015.
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Salix Pharmaceuticals SLXP, Mallinckrodt MNK and Lannett Company, Inc. LCI. Al three carry a Zacks Rank #1 (Strong Buy).
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