NICE now backs Xtandi regardless of Zytiga use

The U.K.'s NICE issued final Xtandi enzalutamide from Astellas Pharma Inc. (Tokyo:4503) for hormone-relapsed, metastatic prostate cancer that progressed on or after one or more docetaxel-containing regimens -- the drug's approved indication in Europe. The new draft guidance removes language included in January draft guidance that restricted use of Xtandi to patients who have not been treated with Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ). NICE said Astellas submitted new observational data that showed that a proportion of patients may benefit from Xtandi after Zytiga treatment. The recommendation is still contingent on Astellas providing Xtandi at an undisclosed discount under a patient access scheme. Astellas is partnered with Medivation Inc. (NASDAQ:MDVN) to develop and commercialize the oral androgen receptor antagonist.

Separately on Thursday, Medivation reported 1Q14 financial results that missed the Street but raised its full-year U.S. sales guidance for Xtandi, which had first quarter net sales of $172.3 million. The company said it now expects 2014 U.S. net sales of $540-$575 million. In February, Medivation fell $12.61 (15%) to $71.91 after introducing full-year U.S. Xtandi net sales guidance of $500-$535 million, which was below Street expectations. ...