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Astellas/Toa Eiyo's Bisono Tape OK'd

Zacks Equity Research

Astellas Pharma Inc. (ALPMY) 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 Santarus, Inc. (SNTS), Salix Pharmaceuticals Ltd. (SLXP)  and Jazz Pharmaceuticals Public Limited Company (JAZZ) look well positioned in the pharma space with a Zacks Rank #1 (Strong Buy).

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