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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