Astellas Pharma (ALPMY) 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 transplant.
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 Graceptor.
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, Jazz Pharmaceuticals (JAZZ - Analyst Report), Shire (SHPG - Analyst Report) and Ironwood Pharmaceuticals (IRWD - Analyst Report) look well positioned, each with a Zacks Rank #2 (Buy).