Astellas wins OK for broader use of key drug in Japan

TOKYO, July 7 (Reuters) - Astellas Pharma Inc 4503.T, Japan's second-largest drugmaker, said on Tuesday it has won approval to sell its key transplant drug Prograf in Japan as a treatment for severe ulcerative colitis, a form of intestinal inflammation.

Prograf is Astellas’ top-selling product, contributing 201 billion yen ($2.11 billion), or 21 percent of the company’s overall revenues, last business year. But the company expects to post a 4 percent revenue drop from Prograf this financial year after losing patent protection in the United States and Europe.

The company had said it was applying for the broader use of Prograf, an Astellas spokesman said.

The company said in a statement that Prograf has previously been approved in Japan for treating a number of illnesses including rheumatism and general myasthenia, an autoimmune neuromuscular disease.

In the United States, where Prograf lost patent protection in April last year, Astellas expects competition from a generic rival in the financial year ending in March 2010.

The drug’s Japan sales totaled 29 billion yen last financial year and are expected to rise 22 percent in this financial year, helping compensate for sharp falls expected in the United States and Europe. (Reporting by Yumiko Nishitani; Editing by Elaine Lies and Hugh Lawson)