) and partner,
Johnson & Johnson
) Janssen Research and Development unit, recently announced that
the US Food and Drug Administration (FDA) will review their
marketing application for blood thinner Xarelto for an additional
indication on a priority basis.
We note that the US regulatory authority generally reviews those
drugs on a priority basis, which offer major advances in treating
diseases that do not have adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within six
months of submission as against the usual ten months.
The supplemental new drug application (sNDA) was filed on May 2,
2012. Consequently, a response should be out in the fourth quarter
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The partners are looking to expand Xarelto's label for the
treatment of patients suffering from deep vein thrombosis (DVT) or
pulmonary embolism (PE) and the prevention of recurrent DVT and PE.
We note that thrombosis refers to the formation of a blood clot
inside a blood vessel thereby blocking a vein (venous thrombosis)
or artery (arterial thrombosis).
Bayer/Johnson & Johnson submitted the sNDA to the FDA on the
basis of data from a phase III program (EINSTEIN, n~10,000) which
consisted of three studies. The studies evaluated the safety and
efficacy of Xarelto for treating DVT and PE and the prevention of
recurrent venous thromboembolism (VTE).
We are encouraged by Bayer/Johnson & Johnson's label expansion
efforts for Xarelto, which is already approved for multiple
indications. Successful label expansion should boost the sales
potential of the drug.
Marketing Application Withdrawn
Meanwhile, Bayer/Johnson & Johnson announced the withdrawal of
their sNDA seeking US approval of Xarelto for reducing the risk of
stent thrombosis in patients suffering from acute coronary syndrome
(ACS). ACS refers to a heart disease, which results in the blockage
of a coronary artery via a blood clot.
The decision to withdraw the sNDA follows the complete response
letter (CRL) issued by the FDA last month to the companies.
Bayer/Johnson & Johnson are working on the queries raised by
the FDA in the CRL. The companies intend to re-submit the sNDA to
the FDA in the stent thrombosis indication at the time of filing
their response to the CRL.
Currently, we have a Neutral stance on Bayer in the long run. The
company carries a Zacks #3 Rank (Hold rating) in the short run. Our
long-term recommendation is similar on Johnson & Johnson.
However, the stock carries a Zacks #2 Rank (Buy rating) in the