Reversal Of Fortune? A J&J Pill And Provenge

Reversal Of Fortune? A J&J Pill And Provenge

October 11th, 2011 // 1:26 pm @

After years of controversy, the Provenge prostate cancer vaccine that was hailed as a breakthrough medication was finally approved last year. Many patients and investors cheered. The saga – which was replete with contoversy engulfing the FDA and its approval process – appeared set for a happy ending in which prostate cancer treatment would enter a significant and productive new stage.

Now, though, the Provenge story is taking a decidedly sobering turn. Two months ago, you may recall, Dendreon, which sells the vaccine, unexpectedly disclosed that some doctors were failing to embrace Provenge, sales forecasts would be trimmed and layoffs would occur (see this and this). At the time, confusion over reimbursement was blamed, although controversy remained about the $93,000 price tag (look here and here).

Now, yet another issue is emerging for Dendreon – in the form of a pill. A rival med known as Zytiga, which is sold by Johnson & Johnson, was approved last April to treat advanced prostate cancer patients who did not benefit from chemotherapy. And a Reuters report suggests its convenience and apparent ability to provide relief from symptoms is winning the backing of a growing number of doctors.

The median survival benefit from Provenge was 4.1 months, according to study data, although the vaccine does not significantly delay progression of symptoms [UPDATE: For more on the data, see here]. Meanwhile, the news service notes Provenge administration takes several steps, including taking patient white blood cells and sending these to Dendreon facilities to be combined with vaccine components. (By contrast, three Zytiga pills must be taken simultaenously each day).

The J&J pill also prolonged life by 4.6 months in clinical trials (read here), but patients reportedly experience symptoms sooner than with Provenge, according to Reuters, which notes that analysts say Dendreon faces more difficulty than simply convincing doctors that reimbursement will not be an issue. “The bloom is off the rose for Provenge, because patients are looking for something that can treat them more quickly,” and with greater convenience, Charles Duncan, a biotech analyst at JMP Securities, tells the news service.

Zytiga “is taking the market by storm. There is a much faster effect with it,” Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, tells the news service. “Patients feel they’re getting something beneficial. Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do. “The patient says, ‘Look, I really don’t see the need to sit here and send my (blood) to wherever. I really don’t want to wait. I want to take a pill and go to Florida.’ ”

[UPDATE: We should note that a recent essay in the Journal of Clinical Oncology suggested that Provenge should be administered before Zytiga. You can read that here. The author, for those who track this sort of thing, has served as a consultant to both Dendreon and J&J.]

Another issue is likely to be cost. Although the Provenge price tag may prove to be less expensive than the overall cost of undergoing chemotherapy, Zytiga may have an advantage. The J&J pill carries a steep $5,000 monthly price, but over eight cycles, this amounts to $40,000, which is less than Provenge. Consequently, Reuters notes Duncan projects Provenge is likely to generate peak annual sales of no more than $500 million, compared with higher estimates from others that, in some cases, had reached as much as $4 billion. (By the way, last month, Sanford Bernstein analyst Geoff Porges also forecast Provenge sales may not exceed $450 million, and not until 2021).

And so, as Zytiga generates additional interest in the medical community, Dendreon execs can be expected to find it still more difficult to regain lost ground. Since their surprise announcement this past summer, Dendreon shares have floundered. Before the bad news was released, the shares traded as high as $43.96, but since then the stock has been trading below $9.

Source: Pharmalot


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