Dendreon sets aside $50m for Provenge facility
pharmafile | June 24, 2009 | News story | Manufacturing and Production |Â Â Dendreon, USÂ
US biotechnology company Dendreon revealed its confidence in lead drug Provenge for prostate cancer with the announcement it will invest up to $50 million in production facilities for the product.
Dendreon still doesn't have any products on the market but has high hopes that active cellular immunotherapy Provenge (sipuleucel-T) will be its first commercial product, and a blockbuster to boot.
And unlike many biotech companies in these lean times, the company also has financial resources at its disposal, having closed last month on a $221 million financing round that was intended to fund the manufacturing expansion, as well as other operational activities such as the creation of sales and marketing capabilities.
Dendreon says it plans to file for approval of Provenge in the fourth quarter of 2009 based on the results of the recently-unveiled IMPACT trial, which found a four-month increase in overall survival for the drug compared to placebo in men with advanced prostate cancer.
The survival improvement is greater than has been seen in trials of chemotherapy in this patient group and that efficacy, coupled with the fact that prostate cancer is one of the most frequently-diagnosed malignancies in men, has buoyed up product sales forecasts. For example, analysts at Rodman & Renshaw have suggested Provenge could achieve $2 billion in peak sales.
In a filing to the US Securities & Exchange Commission, Dendreon said that it had retained construction firm Henderson to build "phase II and phase III" of its 158,000 sq. ft. therapeutic bioprocessing facility in Morris Plans, New Jersey`
The unit has already been used to make supplies of Provenge for clinical trials, alongside Dendreon's pilot plant in Seattle.
Phase II of the project will see the addition of more quality control laboratory space, a data centre, training areas and offices and is expected to complete by the end of the year the firm said. Phase III is due to end in April 2010 and will add manufacturing cleanrooms, production support areas, warehousing and additional offices.
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