No impact on PCa agent following bankruptcy filing

Dendreon Corp., the maker of sipuleucel-T (Provenge), said it expects no impact on access to the prostate cancer immunotherapy following the company’s Chapter 11 filing last week.

In a separate but related announcement, Bayer HealthCare said it has resumed production of its prostate cancer agent radium Ra 223 dichloride (Xofigo) following a production issue that led to a shortage of the drug.

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Dendreon said in a statement that it had reached agreements on the terms of a financial restructuring with certain holders of convertible senior notes. Under the terms of the agreements, the financial restructuring may take the form of a stand-alone recapitalization or a sale of the company or its assets, the company said.

“The transactions under the agreements will enable continued delivery of Provenge without disruption or impact to access for providers and appropriate patients in need of this revolutionary personalized immunotherapy treatment,” the Dendreon statement said.

To implement the financial restructuring contemplated under the agreements with the noteholders, Dendreon and its U.S. subsidiaries filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware on Nov. 10.

"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, Dendreon’s president and CEO.

Next: Production resumed on radium Ra 223

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In a Nov. 3 letter to physicians, Bayer said it resumed production of radium Ra 223 dichloride and that the initial lot had been released and available for patient treatment. The company issued a second letter on Nov. 11 indicating that production of the agent had resumed for new patients beginning Monday, Nov. 17.

“Bayer recognizes the impact this shortage has had on you and your patients,” the company said. “Identification of the root cause and subsequent return to production have been our top priorities.

Bayer said fibrous particles discovered during routine inspections were found to have originated from vial stoppers. “As a result, Bayer implemented a comprehensive program of corrective and preventative measures in order to restore quality of product and resume patient supply as quickly as possible,” the company said.

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