Astellas Pharma Inc.
) recently announced the approval of Prograf in Japan for an
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
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
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
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
Dr. Reddy's Laboratories Ltd.
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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