Dendreon drops GSK as Provenge manufacturing partner
pharmafile | September 8, 2011 | News story | Manufacturing and Production |Â Â Dendreon, GSK, Provenge, pharma manufacturing newsÂ
Dendreon has called a halt to its manufacturing and supply deal with GlaxoSmithKline for cancer vaccine Provenge, citing “delays and implementation difficulties in achieving the commercial purpose of the agreement”.
The US biotechnology company entered into the agreement with GSK a year ago. The UK-headquartered multinational was contracted to produce and supply the antigen used in the manufacture of Provenge (sipuleucel-T), which was launched in April 2010 as the world’s first patient-specific prostate cancer immunotherapy.
The drug is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
In a statement, Dendreon said a two-month severance clause in the contract requires it to pay GSK $2 million a month in September and October.
Dendreon gave notice of the termination of the contract five days after the US FDA approved its Atlanta cancer immunotherapy manufacturing facility, the third site at which the company will produce Provenge after facilities in New Jersey and Los Angeles.
The company initially signed the agreement with GSK amid widespread concern that its manufacturing capacity for Provenge would not be able to keep up with anticipated demand. At the time Dendreon said it would only be able to make around 2,000 courses of the immunotherapy before the end of the year, as it had only one facility operating at around 25% capacity.
The company had been predicting Provenge sales of $300-$400 million this year, but has scaled that back after initial take-up of the product was slower than anticipated.
In the first six months of this year the drug added around $75 million to Dendreon’s coffers, although there are signs that take-up is gathering momentum following the Centers for Medicare and Medicaid Services (CMS) decision in June to reimburse on-label use.
Phil Taylor
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