) recently announced the launch of Astagraf XL (tacrolimus
extended-release capsules) in the U.S.
Astagraf XL was approved in the U.S. in Jul 2013 for the
prophylaxis of organ rejection in patients receiving a kidney
transplant used with mycophenolate mofetil (MMF) and
corticosteroids, with or without basiliximab induction.
As per Astellas, Astagraf XL is the first once-daily oral
tacrolimus formulation to be marketed in the U.S. for the
prevention of organ rejection in patients receiving a kidney
We remind investors that approval was based on positive
results from 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
Astagraf XL should help replace some of the sales lost to
generic competition for Prograf (tacrolimus). Prograf is approved
in the U.S, to prevent organ rejection in patients who have had a
kidney, liver or heart transplant.
We are encouraged by the company's efforts to expand
geographically. Last month, Astellas launched its prostate cancer
drug, Xtandi, in the UK.
The launch of these drugs in additional markets should boost
the top-line in fiscal 2013. The company expects sales of ¥1.17
billion in fiscal 2013. We expect further updates on the same
when the company announces second quarter results.
Astellas carries a Zacks Rank #3 (Hold). Right now,
) look well positioned, each with a Zacks Rank #2 (Buy).
ASTELLAS PHARMA (ALPMY): Get Free Report
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