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Pipeline Progresses at J&J

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Janssen-Cilag GmbH, a part of Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Companies, recently acquired privately held German drug development company Corimmun GmbH. Besides making an upfront payment, Janssen will a payment on the achievement of a development-based milestone. Other financial details were not disclosed.

With this acquisition, Janssen has gained access to early-stage heart failure treatment candidate COR-1. Preclinical data indicates that COR-1 can improve heart function by reducing autoimmune, beta 1 receptor-simulating antibody effects.

Meanwhile, Janssen-Cilag International NV provided an update on the status of its type II diabetes candidate, canagliflozin. The company said that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (:EMA) for the candidate. We note that a new drug application for canagliflozin was submitted to the US Food and Drug Administration (:FDA) in May 2012.

Janssen-Cilag also reported that its application for the subcutaneous use of Velcade for the treatment of multiple myeloma gained a positive opinion from the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (:EMA). A final response from the EMA should be out shortly.

The company is looking to gain approval for the subcutaneous use of Velcade as it is more convenient to use and has fewer side effects. The occurrence of peripheral neuropathy, pain and tingling in the extremities, common side effects of Velcade, is significantly lower when Velcade is administered subcutaneously.

We note that Velcade is already approved for subcutaneous use in the US and Canada. Another player in the multiple myeloma market is Celgene Corp.'s (CELG) Revlimid.

We are encouraged by Johnson & Johnson’s progress with its pipeline. A few weeks back, the company's Janssen Research & Development, LLC 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.

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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