Roche (RHHBY - Analyst Report) recently announced that the European Medicines Agency (EMA) has approved Perjeta (pertuzumab) as a combination therapy for the treatment of adults with previously untreated HER2-positive metastatic breast cancer (mBC).
HER2-positive cancer is an aggressive form of breast cancer, which is the most common cancer among women.
The EU’s decision was based on positive results from the phase III CLEOPATRA study. The results demonstrated that the risk of death was reduced by 34% in patients who received the combination of Perjeta, Herceptin and chemotherapy in comparison to patients receiving the combination of Herceptin and chemotherapy alone.
The approval does not come as a surprise since in Dec 2012 the Committee for Medicinal Products for Human Use (CHMP) of the EMA had recommended the approval of Perjeta for the indication.
We note that the US Food and Drug Administration (FDA) approved Perjeta plus Herceptin and docetaxel chemotherapy for treating HER2-positive mBC in patients in Jun 2012.
Roche also received approval for Perjeta in Switzerland and Mexico in Aug 2012 and Sep 2012, respectively. Moreover, Roche expects to get Perjeta approved in more countries in 2013.
We remind investors that in Feb 2013, the FDA approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of patients suffering from HER2-positive mBC.
We believe the approvals of Perjeta and Kadcyla has strengthened the company’s HER2-franchise considerably. Roche expects Perjeta and Kadcyla to positively impact results in 2013
Roche currently carries a Zacks Rank #4 (Sell). Pharma stocks, which currently look well placed, include Mylan Inc. (MYL - Analyst Report) , Shire plc (SHPG) and Furiex Pharmaceuticals . All three stocks carry a Zacks Rank #2 (Buy).