Dendreon has finished the construction of its New Jersey manufacturing facility which it will use to produce its investigational active cellular immunotherapy for advanced prostate cancer, hoping to be the first to bring it to patients.
The new facility has the capacity to support clinical processes and future anticipated commercial needs for Dendreon's Provenge (sipuleucel-T), that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system.
More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of the disease diagnosed each year and more than 30,000 men dying each year of the disease.
"The completion of the initial build-out of our New Jersey manufacturing facility is an important milestone on the path to our Provenge license application for marketing approval, which we plan to submit to the FDA later this year," said Mitchell Gold, president of Dendreon.
"We are committed to bringing Provenge to the market to help the many men with late-stage prostate cancer and believe this achievement brings us one step closer to this goal."
The drug is currently in Phase III and, if approved, Provenge would become the first commercially available active cellular immunotherapy designed to stimulate a man's own immune system to treat advanced hormone-refractory prostate cancer.
It is delivered via Dendreon's proprietary antigen delivery cassette technology, which uses a recombinant form of an antigen found in approximately 95 per cent of prostate cancers, prostatic acid phosphatase (PAP), to stimulate the patient's immune system to attack the cancer cells.
But Dendreon is not looking just in-house for the manufacturing of the drug; in March, the US biotechnology firm awarded Diosynth with a long-term contract to produce the recombinant protein antigen component of Provenge.
Diosynth has already been producing the recombinant protein antigen component of the product on a small scale to supply clinical trials from its plant in North Carolina, US and has since scaled up manufacturing capacity to meet expected commercial demand.
Once approved by the FDA, Dendreon will use the recombinant protein antigen supplied by Diosynth to manufacture Provenge for market launch and commercial sale in its new facility in New Jersey.
The commercial launch of the drug will depend largely on whether any established survival benefit is significant enough for the FDA to accept the data and give the green light for production.