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Astellas Pharma Inc. (ALPMY) recently announced the approval of Prograf in Japan for an additional indication.

Prograf is now approved for interstitial pneumonia associated with polymyositis/dermatomyositis. It was granted orphan drug status by the Ministry of Health, Labor and Welfare (MHLW).

Prograf is already available in Japan to prevent organ rejection in transplant recipients, the prevention of rejection in bone marrow transplant recipients, the treatment of myasthenia gravis, the treatment of rheumatoid arthritis in patients who respond insufficiently to existing therapies, the treatment of moderate/severe refractory (steroid resistance and steroid dependency) ulcerative colitis and also for the treatment of lupus nephritis.

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 is also available in the US to prevent organ rejection in patients who have had a kidney, liver or heart transplant.

US patents for Prograf expired in Apr 2008 and Prograf patents in major European countries expired in Jun 2009.

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

Astellas carries a Zacks Rank #4 (Sell). Astellas recently received a complete response letter (CRL) for tivozanib from the US Food and Drug Administration (FDA). A New Drug Application (NDA) for tivozanib seeking approval for the treatment of patients with advanced renal cell carcinoma (RCC) was submitted in Sep 2012. The FDA has informed that the NDA is not approvable in its present form.

The generic players, Mylan and Dr. Reddy’s, look attractive with a Zacks Rank #2 (Buy).

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