Janssen Research & Development, a part of the Janssen
Pharmaceutical Companies of
Johnson & Johnson
), recently submitted a new drug application (NDA) for its
tuberculosis (TB) candidate, bedaquiline (TMC207).
Janssen is looking to get bedaquiline approved as part of a
combination therapy for pulmonary, multi-drug resistant
tuberculosis (MDR-TB) in adults.
Janssen is seeking accelerated approval for the oral TB
treatment. FDA approval would make bedaquiline the first TB
candidate to gain approval in more than 40 years. Moreover,
bedaquiline would be the first and only treatment to be approved
We are encouraged by Johnson & Johnson's progress with its
pipeline. A few weeks back, Janssen had submitted a supplemental
New Drug Application (sNDA) seeking FDA approval for Zytiga
(abiraterone acetate). A marketing application was submitted in the
EU as well.
Johnson & Johnson is looking to get Zytiga's label expanded
for use in chemotherapy-naïve patients with metastatic
castration-resistant prostate cancer (mCRPC) who are asymptomatic
or mildly symptomatic after failure of androgen deprivation
Zytiga is one of the most important and successful new product
launches at Johnson & Johnson. Approval for the
chemotherapy-naïve patient population would increase Zytiga's sales
potential significantly. If approved for the chemotherapy-naive
indication, Zytiga will be used in patients at an earlier stage of
Another company looking to enter the prostate cancer market is
). Medivation and partner, Astellas Pharma Inc., are seeking FDA
approval for enzalutamide for use in castration-resistant prostate
cancer patients who have received docetaxel therapy.
Neutral on Johnson & Johnson
We currently have a Neutral recommendation on Johnson &
Johnson. The company carries a Zacks #2 Rank (short-term Buy
rating). We are positive on the recently completed Synthes
acquisition which is expected to boost 2012 adjusted earnings by
3-5 cents per share and 2013 earnings by 10-15 cents per share.
JOHNSON & JOHNS (JNJ): Free Stock Analysis
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