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NDA Filed for J&J Drug

Zacks Equity Research

Janssen Research & Development, a part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), 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 for MDR-TB.

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 therapy.

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 their disease.

Another company looking to enter the prostate cancer market is Medivation, Inc. (MDVN). 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.

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