Astellas Pharma Inc.
) and partner Toa Eiyo Ltd. recently announced the receipt of
marketing approval for their transdermal patch Bisono Tape (4 mg
and 8 mg) in Japan.
Bisono Tape, a patch of β1 blocker, is a hypertension
medication containing 4 mg or 8 mg of bisoprolol.
The approval was based on phase III studies that showed
continuous antihypertensive effects over a period of 24 hours in
Japanese mild-to-moderate essential hypertensive patients.
Toa Eiyo and Nitto Denko Corp. co-developed Bisono Tape.
Astellas will be responsible for distributing and selling the
product, following the Japanese approval. Astellas and Toa Eiyo
will co-promote the product.
The hypertension market in Japan is crowded with products like
Avapro, Aimix and Azilva receiving marketing approval on Mar 19,
2013, Sep 28, 2012 and Jan 18, 2012 respectively.
We note that Astellas was also in the news recently when it
gained Japanese approval of Prograf capsules for interstitial
pneumonia associated with polymyositis/dermatomyositis. The
drug enjoys orphan status in Japan.
Astellas carries a Zacks Rank #4 (Sell) reflecting short-term
pressure on the stock. The bearish rank is primarily attributable
to the setback suffered by the company regarding its oncology
candidate tivozanib. Astellas recently received a complete
response letter (CRL) for tivozanib from the US Food and Drug
Administration (FDA) for the advanced renal cell carcinoma
indication. The New Drug Application (NDA) was submitted in Sep
2012. The FDA, while issuing the CRL, declined to approve the NDA
in its present form.
Right now, companies like
Salix Pharmaceuticals Ltd.
Pharmaceuticals Public Limited Company (
look well positioned in the pharma space with a Zacks Rank #1
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