J&J's Yondelis captures FDA nod, but steep path to big sales

Once upon a time, analysts thought the cancer-fighting prospect Yondelis could hit $1 billion in sales by 2010. But that timetable went poof years ago--and so did the forecast--as the drug failed to win the FDA's approval, and eventually ended up in a partnership between Spain's Zeltia and Johnson & Johnson's ($JNJ) Janssen unit.

But now, after years of setbacks, Yondelis at least has its shot at some U.S. sales. The drug won its sought-after FDA approval Friday--not in ovarian cancer as previously hoped, but as a treatment for soft-tissue sarcoma. The drug had won priority review from the FDA earlier this year in that use, which otherwise has few treatment options.

Just what the FDA nod means in terms of sales remains to be seen. But if the European market is any indication, uptake won't break any records. First approved there in 2007, Yondelis is marketed for ovarian cancer and soft-tissue sarcoma, and its sales for the first half of 2015 stood at €43.6 million, an 11% increase year over year.

Part of the problem is that Yondelis hasn't proven to extend patients' lives, and as the FDA notes in its announcement of the approval, its effect on progression-free survival is modest. In a head-to-head study against the chemotherapy dacarbazine, Yondelis held off cancer growth for a median of 4.2 months, compared with 1.5 months with the older chemo med.

But expanding into the U.S. market can only be a positive thing for the drug, partly because prices are expected to be higher than in the other countries where Yondelis is currently sold. The FDA nod also follows approval in Japan, where it will be marketed by Otsuka Pharmaceuticals.

Zeltia, at least, is looking forward to the revenue boost from larger royalty payments. "In these markets Yondelis is likely to be priced at a premium to Europe and royalty receipts should significantly boost revenues and profitability," Edison analysts said when it stepped on the FDA fast track in February. The FDA approval could "have positive knock-on effects on European sales" as well, they said.

FDA's Richard Pazdur

Patient advocates cheered the approval, and the FDA said Yondelis would offer a new option for those suffering from this type of cancer. "The treatment of advanced or metastatic soft tissue sarcoma represents a difficult challenge with few effective therapeutic choices available for patients," said Richard Pazdur, who heads up the FDA's oncology division in the Center for Drug Evaluation and Research.

- read the statement

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