PharmaMar, J&J sales and marketing update

PharmaMar said the commercial supply of cancer drug Caelyx pegylated liposomal doxorubicin from Johnson & Johnson has been restored in the EU, along with Liechtenstein, Norway and Switzerland. In November 2011, EMA's CHMP said no new patients should be treated with Caelyx after identifying "shortcomings" at the liposomal doxorubicin's sole EU manufacturing site, particularly with the aseptic filling process. As a result, the third-party manufacturer, Ben Venue Laboratories Inc., stopped all manufacture and distribution of medicines from its site. CHMP said at the time there could be a restricted supply in the EU. Last March, EMA recommended that the manufacturing process for Caelyx be transferred to alternative facilities. The alternative site was authorized last October. Last month, CHMP determined that the new site produced sufficient Caelyx to restore EU supply levels and recommended that Caelyx be used again without restrictions. Ben Venue is a subsidiary of Boehringer Ingelheim GmbH (Ingelheim, Germany) (see BioCentury, Dec. 5, 2011& March 26, 2012).

PharmaMar's Yondelis trabectedin is approved in Europe in combination with Caelyx to treat relapsed platinum-sensitive ovarian cancer. J&J has rights to Yondelis - a cytotoxic alkaloid that binds the minor groove of DNA - outside of Europe and Japan from PharmaMar, a subsidiary of Zeltia S.A. (Madrid:ZEL, Madrid, Spain), while the Taiho Pharmaceutical Co. Ltd. subsidiary of Otsuka Holdings Co. Ltd. (Tokyo:4578, Tokyo, Japan) has exclusive rights to the product in Japan. J&J markets doxorubicin as Doxil in the U.S. and elsewhere as Caelyx. ...