In November last year, Seattle-based biotech firm Dendreon Corporation announced it had filed for bankruptcy with the US Court for the District of Delaware as part of a financial restructuring. The firm’s personalised therapy treatment Provenge (sipuleucel-T) was put up for sale with interested parties invited to declare their interest to take part in an auction next month by January 27.
The deadline was extended two days, and yesterday Valeant Pharmaceuticals International emerged as lead buyer for Provenge and certain other Dendreon assets, assessing the market with a ‘stalking horse’ bid of $296m (€261m).
“We believe that oncology has similar characteristics to our current therapeutic portfolios, such as strong growth, high durability, strong patient and physician loyalty, and a terrific reimbursement regime,” said Valeant CEO J. Michael Pearson.
“We have not previously found an economic way to enter this market,” he added.
Provenge received US FDA approval in 2010, and is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond. The drug is made by taking immune (dendritic) cells from a patient, incubating these with a fusion protein the antigen prostatic acid phosphatase (PAP), found in 95% of prostate cancer cells, and then re-infusing the cells back into the patient.
Sales of the drug stood at around $300m in 2014.
Manufacturing continues
In the US, Dendreon makes the treatment from its own facilities in California and Georgia, but for European patients the company contracted CMO PharmaCell to manufacture the product from its facility in Maastricht, The Netherlands.
Dendreon’s upcoming auction on February 12 raises questions as to the manufacture of Provenge, and PharmaCell CEO Alexander Vos told Biopharma-Reporter.com his firm is “not in a position to comment on [its] relationship and the status of the project with them in Europe.”
However, documents from the firm’s bankruptcy agents Prime Clerk reveal Provenge “is and will continue to be available for patients” through the financial restructuring, and Dendreon announced earlier this month the first commercial patient in Europe began treatment with the drug.
If Valeant does emerge successful in its bid, it is likely it will continue to outsource production of Provenge as the firm describes itself as a ‘virtual pharma,’ managing upwards of 800 contract manufacturing organisations and service providers across its network.