Chugai gains Japanese approval for Perjeta and Bonviva

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) said this morning (June 28) that it has obtained approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) for two new products, the first being for HER2-positive inoperable or recurrent breast cancer, for the anti-cancer agent/anti-HER2 humanized monoclonal antibody, Perjeta IV Infusion (pertuzumab [genetical recombination]).

Perjeta was approved for patients with previously untreated HER2-positive metastatic breast cancer in the USA in June 2012 and in Europe in March 2013, where it is marketed by Chugai’s majority owner, Swiss drug major Roche (ROG: SIX). Analysts polled by Thomson Reuters have on average forecast annual global pertuzumab sales of $608 million by 2016 - though some say revenues could eventually climb beyond $1 billion.

In May 2012, Chugai filed a New Drug Application for approval for HER2-positive inoperable or recurrent breast cancer with the MHLW based on the results from a Japanese Phase I clinical trial and a global phase III clinical trial (The CLEOPATRA trial), which included Japanese patients.