(DNDN) Dendreon Gets FDA Clearance on Second Facility

Dendreon Corporation (DNDN) 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.

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.

Our Recommendation

We currently have a Neutral recommendation on Dendreon. The stock carries a Zacks #3 Rank (short-term Hold recommendation). We believe that the launch of Dendreon’s potential blockbuster drug, Provenge, has been impressive. Successful commercialization of Provenge is crucial for the financial performance of Dendreon as it can drive the company to profitability.

We are encouraged by the company’s efforts to expand capacity and Centers for Medicare & Medicaid Services’ (CMS) proposed decision to reimburse Provenge for on-label usage, which could subsequently spur sales at Dendreon. However, in the long run, we remain concerned about the company’s dependence on Provenge and the lack of a robust pipeline.

We believe Dendreon has little to fall back on if Provenge fails to keep its promise. We also remain cautious of the continuous uptick in operating expenses.

Moreover, there are products currently under development for treatment of prostate cancer. Johnson and Johnson’s (JNJ) Zytiga (abiraterone acetate) received FDA approval in April 2011 and Medivation’s (MDVN) MDV3100 is in late stage trials. If these products prove to be successful, the prostate cancer market will become more crowded and competitive.

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