The EU released a round of new drug approvals today, including Novartis’ (NYSE:NVS) breast-cancer treatment Afinitor which was approved by the FDA two weeks ago. Vertex Pharmaceuticals (NASDAQ:VRTX) also received EMA certification of Kalydeco for the treatment of cystic fibrosis.
Novartis expects Afinitor to have peak sales of over $1B annually with the latest approval. The drug is approved for treatment of not only advanced breast cancer, but some kidney, pancreatic, and brain cancers. After losing exclusivity on Diovan in the EU and Canada, and slumping sales in the U.S., Novartis can use the kickstart from some new block buster drugs. Novartis retained its 2012 outlook in its latest earnings report and saw mostly flat movement in the quarter. Shares are trading down slightly today but have been moving back up towards Friday’s closing price.
Kalydeco, indicated for the treatment of a rare form of cystic fibrosis, helps to reduce mucus buildup in the lungs and other organs – a hallmark of the disease. Although treatments exist, Kalydeco may be the first to genetically target the underlying cause of the disease rather than treat symptoms alone. Its hefty ~$300,000 pricetag and small patient population – just over 2000 people in Europe and the U.S. have the particular G551D mutation – may slow revenue, but the company is working with organizations and the government to reduce costs for patients. The drug was approved for use in the U.S. in January. Shares are up today by just over 1% to $50.00, and analysts’ average price target is $66.40.