Johnson & Johnson's
) 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
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
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
), which carries a Zacks #2 Rank (Buy).
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