FDA Clears Dendreon 2nd Facility

FDA Clears Dendreon 2nd Facility

July 1st, 2011 // 12:41 pm @

Dendreon Corporation recently received clearance from the U.S. Food and Drug Administration (FDA) to expand manufacturing facility for its cancer vaccine Provenge, in the U.S. The company’s Los Angeles facility can now be operational with 36 workstations. These facilities will be brought online in a staged manner.

Earlier, in March 2011, Dendreon’s New Jersey facility received FDA clearance. The facility has 48 workstations, some of which are already operational. The LA and NJ facilities, geared for manufacturing Provenge, now total 84. We believe the expanding manufacturing capacity will significantly increase the availability of Provenge which will help Dendreon to meet pent up demand for the vaccine.

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The company is also building additional capacity in Atlanta for which the FDA is expected to give its decision in August 2011. All the three facilities are thus expected to be manufacturing commercial material by year end. Hence, the company expects capacity to increase ten fold during 2011.

The company expects 2011 revenues from Provenge in the range of $350 million to $400 million, half of which is expected to be realized in the fourth quarter, once all the facilities become operational. Dendreon expects to have 500 centers, where patients can be treated with Provenge, by the end of 2011.

Unlike traditional vaccines that prevent diseases, Provenge treats by stimulating the body’s own immune system to attack cancer cells. Provenge is the first product in the new therapeutic class known as active cellular immunotherapies (ACI).

Prostate cancer is the most common non-skin cancer in men in the U.S. The disease affects more than 2 million men in the US

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