Physician Views: Bayer's M&A catalyst – is Xofigo a paradigm shifter for the prostate cancer market?
Already positioned as one of the most commercially promising new drug approvals of 2013, Algeta and Bayer's prostate cancer treatment Xofigo is now driving what appears to be the inevitable acquisition of the former by the latter.
Buoyed by a stronger than expected launch in Q3, a number of analysts have speculated that Bayer perceives there to be an increasingly more compelling outlook for Xofigo. One sufficient to drive the diligent German player to move for Algeta, despite the Norwegian company's value already reflecting strong anticipated uptake for the radiopharmaceutical - see In Focus: Bayer's M&A catalyst – FirstWord speaks to Xofigo's lead investigator.
Impressive Q3 sales, and confirmation that Bayer and Algeta are racing towards their target for initialising the specialist treatment centres that are required to prescribe the drug, have helped to diminish fears that Xofigo would face teething troubles due to its status as a radiopharmaceutical.
Longer-term prospects for Xofigo will be shaped by a number of factors, however, not least whether urologists and oncologists prescribe it in combination with other prostate cancer treatments such as Johnson & Johnson's Zytiga and Medivation and Astellas' Xtandi.
Its use in both the pre- and post-chemotherapy settings will also play a pivotal role in driving sales (its broad label permits such use), as will the potential to retreat patients after their initial run of six infusions.
Bayer recently confirmed that Phase III studies in combination with Zytiga have been initiated, but will read out in 2017. Some analysts appear concerned at both the study design – which does not have overall survival as its primary endpoint – and its relevance by 2017 (when existing therapies may have shifted to an even earlier position in the treatment paradigm).
Thus the mid-term performance of Xofigo could depend on whether physicians utilise a flexible approach towards the product, rather than wait for additional clinical data. As a completely separate mode of action, for example, there should be little mechanistic reason for not prescribing Bayer's drug in combination with Zytiga or Xtandi, note key opinion leaders (KOLs) interviewed by FirstWord's Therapy Trends team, although payers of course may need more convincing.
To gain a better understanding of the outlook for Xofigo, this week's Physician Views poll will ask US-based urologists and oncologists...
Where in the prostate cancer treatment algorithm they are using/initially expect to use Xofigo?
Whether they will prescribe in combination with Zytiga/Xtandi prior to Phase III data?
How they assess the design of Bayer's Phase III combination study with Zytiga – and how results may/may not influence prescribing habits?
How logistically convenient the Xofigo treatment process has been since launch?
How comfortable they are with the concept of retreating patients after six initial courses of therapy?
Buoyed by a stronger than expected launch in Q3, a number of analysts have speculated that Bayer perceives there to be an increasingly more compelling outlook for Xofigo. One sufficient to drive the diligent German player to move for Algeta, despite the Norwegian company's value already reflecting strong anticipated uptake for the radiopharmaceutical - see In Focus: Bayer's M&A catalyst – FirstWord speaks to Xofigo's lead investigator.
Impressive Q3 sales, and confirmation that Bayer and Algeta are racing towards their target for initialising the specialist treatment centres that are required to prescribe the drug, have helped to diminish fears that Xofigo would face teething troubles due to its status as a radiopharmaceutical.
Longer-term prospects for Xofigo will be shaped by a number of factors, however, not least whether urologists and oncologists prescribe it in combination with other prostate cancer treatments such as Johnson & Johnson's Zytiga and Medivation and Astellas' Xtandi.
Its use in both the pre- and post-chemotherapy settings will also play a pivotal role in driving sales (its broad label permits such use), as will the potential to retreat patients after their initial run of six infusions.
Bayer recently confirmed that Phase III studies in combination with Zytiga have been initiated, but will read out in 2017. Some analysts appear concerned at both the study design – which does not have overall survival as its primary endpoint – and its relevance by 2017 (when existing therapies may have shifted to an even earlier position in the treatment paradigm).
Thus the mid-term performance of Xofigo could depend on whether physicians utilise a flexible approach towards the product, rather than wait for additional clinical data. As a completely separate mode of action, for example, there should be little mechanistic reason for not prescribing Bayer's drug in combination with Zytiga or Xtandi, note key opinion leaders (KOLs) interviewed by FirstWord's Therapy Trends team, although payers of course may need more convincing.
To gain a better understanding of the outlook for Xofigo, this week's Physician Views poll will ask US-based urologists and oncologists...
Where in the prostate cancer treatment algorithm they are using/initially expect to use Xofigo?
Whether they will prescribe in combination with Zytiga/Xtandi prior to Phase III data?
How they assess the design of Bayer's Phase III combination study with Zytiga – and how results may/may not influence prescribing habits?
How logistically convenient the Xofigo treatment process has been since launch?
How comfortable they are with the concept of retreating patients after six initial courses of therapy?
