Production ramp-up for Provenge on track

Dendreon’s production ramp-up for sipuleucel-T (Provenge®) is on track, the company says, with manufacturing expected to be up to full speed by year’s end. All three US-based manufacturing plants will be shipping by then, and treatment with Provenge should be available at hundreds of more locations, according to a Reuters report last week. The company also has plans for a facility in Europe (according to another, earlier Reuters report), with its application to market Provenge slated to go to European authorities late this year or early next year, and a decision anticipated in the first half of 2013.

After approval in the US in April last year, a shortage of manufacturing capacity kept Dendreon from rolling out the treatment in a big way. (Provenge is still its sole product.) The company has submitted its request for approval of additional work stations at its New Jersey and Los Angeles locations to the FDA and is working on a new plant Georgia.

While the company is getting its manufacturing capacity together, it’s also working on adding to its list of approved treatment sites, i.e., infusion centers. Dendreon predicts it will have 225 infusion centers ready to go by mid-year and 500 by the end of this year. That’s 10 times the number available at the end of 2010, Reuters reports.

The company’s financial reports seem to suggest that about 500 paying patients got Provenge in 2010, of whom about 270 patients were treated in the last 3 months of the year.

On November 17, 2010, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) gave Provenge a vote of 3.6 out of 5.0, indicating moderately strong confidence that it was effective in extending survival. At the same time, it turned thumbs down on “off-label” use, which means use not in line with the FDA approval description. Such off-label use includes patients who have not yet experienced metastasis. This MEDCAC vote was important information to be considered by the Centers for Medicare and Medicaid Services (CMS), the organization that will decide on coverage policies. Their decision is due by June 30.

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