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Astellas Pharma Inc. (ALPMY) recently received approval for Astagraf XL (tacrolimus extended-release capsules) in the U.S. for the prevention of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

Astagraf XL is the first once-daily oral tacrolimus formulation to be approved in the U.S. for patients receiving a kidney transplant.

The approval was based on two primary, randomized, comparative phase III studies which enrolled 1,093 patients in the U.S., Europe, Canada, South America, Australia and South Africa.

This drug is already approved in the EU since 2007 under the trade name Advagraf and in Japan since 2008 under the trade name Graceptor. The drug is approved in 73 countries across the globe.

We note that Astellas’ Prograf (tacrolimus) is available in the U.S. in the form of IV infusion to prevent organ rejection in patients who have had a kidney, liver or heart transplant. Prograf generated global sales of 161.7 billion yen in 2012, including 49.4 billion yen from Japan, 31.4 billion yen from the Americas, 57.5 billion yen from Europe and 18.9 billion yen from Asia.

Prograf patents expired in the U.S. in Apr 2008 and in major European countries in Jun 2009.

Currently, Prograf faces generic competition in the U.S. Generic versions of Prograf were launched by companies like Mylan Inc (MYL - Analyst Report) and Dr. Reddy's Laboratories Ltd. (RDY - Analyst Report).

Astellas carries a Zacks Rank #4 (Sell). Right now, Jazz Pharmaceuticals Public Limited Company (JAZZ - Analyst Report) looks well positioned with a Zacks Rank #1 (Strong Buy).

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