Johnson & Johnson's ( JNJ ) Janssen Therapeutics recently announced that it gained FDA approval for its tuberculosis treatment, Sirturo (bedaquiline). Sirturo received accelerated approval for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults.
We note that Sirturo carries a boxed warning regarding higher risk of death and the occurrence of QT prolongation.
FDA approval makes Sirturo the first drug to be approved for the treatment of MDR-TB, which is a more difficult-to-treat form of TB. As per the Centers for Disease Control and Prevention, almost 9 million people across the world and 10,528 people in the US were suffering from TB in 2011.
According to the World Health Organization (WHO), more than two million people are expected to develop MDR-TB between 2011 and 2015. Sirturo enjoys fast track designation, priority review and orphan-product designation in the US.
We are encouraged by Johnson & Johnson's progress with its pipeline. Early last month, Johnson & Johnson gained FDA approval for the label expansion of its prostate cancer treatment, Zytiga. Zytiga, which was previously approved for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in treatment-experienced patients whose chemotherapy contained docetaxel, can now be used in chemotherapy-naïve patients as well.
Zytiga, an oral, once-daily medication, is one of the most important and successful new product launches at Johnson & Johnson. Approval for the chemotherapy-naïve patient population will increase Zytiga's sales potential significantly as it can now be used in patients at an earlier stage of their disease. Zytiga sales came in at $265 million in the third quarter of 2012, up 14.2% sequentially.
Johnson & Johnson is looking to get the label expanded in the EU as well where Zytiga received a positive opinion in November.
We currently have a Neutral recommendation on Johnson & Johnson, which carries a Zacks #3 Rank (Hold). Large cap pharma stocks that are better-positioned include Novo Nordisk ( NVO ), which carries a Zacks #2 Rank (Buy).