Novartis distances itself from Pixuvri
This article was originally published in Scrip
Executive Summary
Novartis will not be exercising its option for Cell Therapeutics' non-Hodgkin's lymphoma drug Pixuvri (pixantrone), which it has held since 2006, despite the product finally winning round Europe's reimbursement authorities. It is also returning rights to Opaxio (paclitaxel poliglumex), which it acquired under the same agreement (scripintelligence.com, 22 September 2006). Novartis has failed to show any real interest in either drug since signing the deal.
Novartis will not be exercising its option for Cell Therapeutics' non-Hodgkin's lymphoma drug Pixuvri (pixantrone), which it has held since 2006, despite the product finally winning round Europe's reimbursement authorities. It is also returning rights to Opaxio (paclitaxel poliglumex), which it acquired under the same agreement (scripintelligence.com, 22 September 2006). Novartis has failed to show any real interest in either drug since signing the deal.
Cell Therapeutics began the EU commercial launch of Pixuvri in 2012 following conditional marketing approval earlier that year (scripintelligence.com, 13 September 2012).
A week ago, NICE (the HTA body for England and Wales) finally agreed to reimburse the drug after much negotiation (scripintelligence.com, 7 January 2014). This followed a similar decision in Germany last month (scripintelligence.com, 4 December 2013).
Cell Therapeutics reported revenues for the third quarter and the nine months ended 30 September 2013 of $400,000 and $1.8m, respectively, which were solely attributable to Pixuvri. Pixuvri's US progress has been even less fruitful: Cell Therapeutics withdrew its NDA two years ago (scripintelligence.com, 31 January 2012), following a complete response letter for the product in 2010.
Cell Therapeutics has been solely responsible for the development and commercialization of both Pixuvri and Opaxio (paclitaxel linked to a biodegradable polyglutamate polymer, in Phase III development), and on regaining all rights from Novartis, it has agreed to make "certain potential payments to Novartis based on sales of Opaxio and Pixuvri and on any sublicense."
In contrast, the original deal covering both compounds was worth as much as $397m to Cell Therapeutics, including $270m in milestones for Opaxio, a $7.5m license fee and up to $104m in milestones for Pixuvri. Novartis also made a $15m equity investment in the US biotech firm making it the largest shareholder at the time, with an 8% stake.
"We are pleased that Novartis and CTI were able to reach a mutually beneficial agreement regarding rights to Pixuvri and Opaxio," said Dr James Bianco, CTI's president and CEO, in a face-saving statement. "Regaining full rights to these two anticancer agents provides us with the flexibility to manage these assets within the context of our overall product portfolio strategy."
CTI is currently accruing patients into a Phase III trial comparing Pixuvri and rituximab with gemcitabine and rituximab in aggressive B-cell non-Hodgkin's lymphoma.
Byline(s):
Author | Name | Sukaina Virji |
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