Sipuleucel-T Maker Dendreon Files for Bankruptcy

Philip Kantoff, MD

Dendreon, the maker of the first FDA-approved immunotherapy for advanced prostate cancer, sipuleucel-T (Provenge), has filed for chapter 11 bankruptcy, the company announced November 10, 2014.

Sipuleucel-T will remain available after the financial restructuring of the Seattle-based company, Dendreon said in the written statement.

"Whether the restructuring takes the form of a stand-alone recapitalization or a sale of the company or its assets, we are confident that this process will allow Provenge to remain commercially available to the patients and providers who have come to rely on this revolutionary personalized cancer immunotherapy," said W. Thomas Amick, president and chief executive officer of Dendreon, in the statement. "We are pleased to have the support of a substantial majority of our senior noteholders through this restructuring and sale process. We thank our employees for their continued hard work and dedication and for their commitment to help deliver Provenge to patients who are in need of immunotherapy."

Dendreon said the restructuring is based on agreements with the senior noteholders of the company's 2.875% convertible senior notes due in 2016, representing about 84% of the $620 million aggregate principal amount of the 2016 notes. The senior noteholders have agreed to support a plan that will convert all 2016 notes to common equity of the reorganized Dendreon. In addition, the agreements will allow Dendreon to conduct a court-supervised sale for all or most of its assets, or no less than $275 million, to a party that would continue to produce and provide Provenge, the company’s statement said.

Under the agreement, the money from a sale of the company would go to noteholders; if no sale occurs, noteholders will assume ownership of Dendreon, an article on the Bloomberg.com explained.

Doctor Reactions

Dendreon does not expect to need to raise any incremental financing in connection with the restructuring process. During the restructuring, the company will not only continue to manufacture and distribute sipuleucel-T, but will pay employees and run patient assistance programs, it said.Philip Kantoff, MD, chief of the Division of Solid Tumor Oncology and director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute, in Boston, and a co-author of the phase III study that led to sipuleucel-T’s approval, said that “Provenge was an important first step in immunotherapy,” and that he and his colleagues will continue to prescribe it as long as it remains available.

“To have an effective therapy that goes away completely would be troubling until something took its place, and there’s nothing on the immediate horizon that will,” he said. “So I hope, for the sake of the prostate cancer community, that it remains an option for patients.”

Neal D. Shore, MD, of Atlantic Urology Clinics in Myrtle Beach, South Carolina and also a co-author of the phase III study, said he does not think that Dendreon’s declaration of bankruptcy will affect “the drug or its placement in the armamentarium for metastatic castration-resistant prostate cancer [mCRPC].”

“There is no reason to think that the ongoing manufacturing process would be affected at all, and no reason to think that anyone would change the NCCN [National Comprehensive Cancer Network] or AUA [American Urological Association] guidelines that offer the highest level of evidence that sipuleucel-T is a very appropriate therapy to discuss with patients who have asymptomatic or minimally symptomatic mCRPC. I don’t think that discussion should change for any patient or clinician at the current time.”

Kantoff said it could be sipuleucel-T’s mechanism of action that caused it to be less frequently used than anticipated.

“The challenges that it had were that there was no perceptible change in patients treated with it—PSAs [prostate-specific antigens] didn’t go down, they didn’t feel better, and there was no change in measurable progression-free survival [PFS]. But it did meet a very high bar, which is prolonging overall survival, and since then there have been very strong biological studies supporting the fundamental concept of how it works.

“Secondly, since it was approved, five other drugs have been introduced into the marketplace that prolong survival that have a more measurable response. The benefits of all those are not clearly any better, but there’s an easier readout, because PSAs go down or there’s a change in PFS.”