Janssen looks to broaden Zytiga licence
pharmafile | June 18, 2012 | News story | Sales and Marketing | Cancer, Janssen, NICE, Provenge, Zytiga, prostate
Janssen is looking to broaden the licence for its prostate cancer pill Zytiga.
Zytiga currently has a US and European licence to treat men with metastatic castration-resistant prostate cancer who have already received docetaxel-based chemotherapy.
Janssen is now seeking a licence for the drug, to be used with prednisone, for patients who have not had chemotherapy, opening it up to more patients.
If Zytiga (abiraterone acetate) can win this new indication, that would more than double its target market according to analysts, meaning it could reach peak annual sales of $2.5 billion.
Previous estimates had peak sales at around $900 million, but this new licence should give Janssen better market share.
The new US and European filings are based on interim analyses of around 1,000 patients in a Phase III study published in March.
At this month’s ASCO cancer conference, Janssen said the median radiographic progression-free survival in the control arm was 8.3 months, but that this had not yet been reached in the Zytiga arm because progression events were occurring more slowly in the other arm.
The firm estimated that Zytiga would have at least 16 months rPFS and showed “a trend for increased median overall survival”, which the firm estimated to be about a 33% improvement compared with placebo.
“We’re delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago,” said Michael Meyers, VP of compound development and team leader for Zytiga.
“We look forward to working with the FDA and EMA to make Zytiga available for men with metastatic prostate cancer earlier in the course of their disease.”
Weakening competition
One of the firm’s main competitors in this market is Dendreon’s Provenge, which works as a vaccine against the cancer and has been able to improve overall survival in Phase III studies.
But the firm has been blighted by manufacturing problems, and has not been able to capitalise on its clinical success since the drug’s launch in 2010.
Both drugs are also very expensive, with Zytiga priced at $5,000 a month and Provenge at around $93,000 per patient.
Despite its high cost, Janssen managed to sway NICE into recommending Zytiga on the NHS, given its effectiveness (and an undisclosed price cut).
Provenge is not currently licensed for use in Europe.
Ben Adams
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