U.K.'s nod to J&J's Caelyx comes even as shortages expected

The U.K. drug price watchdog today gave Johnson & Johnson's ($JNJ) Caelyx the distinction of being one of only two drugs it believes should be funded by the National Health System to treat recurring ovarian cancer. It and the standard treatment paclitaxel were two of 5 drugs NICE gave its nod to in draft guidance published. But the boost comes even as J&J's Janssen unit which markets Caelyx notified doctors this week that it expects shortages of the drug starting next month.

Caelyx is known as Doxil in the U.S. and Janssen's sole producer has been Ben Venue Laboratories, the contract manufacturing unit of Boehringer Ingelheim. Ben Venue's plant in Bedford, OH, where the drug is manufactured has been the focus of deep FDA concern since 2011 when the agency found a laundry list of problems there. In fact, when the FDA went public with its concerns two years ago, regulators in Europe had the drug, and two others, recalled. It suggested that J&J and other drugmakers turn to alternate suppliers.

J&J is in the process of doing just that, but the drug is complicated to make, and so far it has not gotten another producer approved to take over production. The FDA, in an effort to address Doxil shortages in the U.S., did approve a multi-step process in which Ben Venue did part of the production and the drug was finished at another facility. The FDA also quickly approved a generic version of the drug from India's Sun Pharma.

The draft guidance from NICE posted today said that it recommended paclitaxel and pegylated liposomal doxorubicin hydrochloride (PLDH), which is Caelyx, for the treatment of ovarian cancer that has returned after chemotherapy. It did not recommend paying for PharmaMar's Yondelis (trabectedin) or the generic drugs topotecan or gemcitabine which Eli Lilly ($LLY) sells as Gemzar.

- read the Pharmafile story
- here's the NICE release
- see the NICE draft guidance