The European Medicines Agency is demanding more information from AstraZeneca on its troubled heart pill Brilinta.
This rounds off a tough few weeks for the firm as it comes after the US Department of Justice (DOJ) took the unusual decision to investigate the product in late October.
Neither AZ nor the DOJ have disclosed the exact nature of the investigation, but analysts believe it relates to various aspects of the study that have been criticised by external researchers.
This includes comments from James DiNicolantonio of Ithaca New York, and Ales Tomek of Charles University in Prague, who said in a recent paper that patients in the PLATO trial monitored by AstraZeneca were reported as benefiting more from taking Brilinta (ticagrelor) - than those monitored by an independent clinical research organisation.
Bernstein analyst Tim Anderson said in a research note this week that there could be ‘material downside’ for AstraZeneca if the DOJ investigation revealed serious flaws in the study.
AstraZeneca’s chief executive Pascal Soriot is not panicking yet, and said last week he was ‘very confident’ in the findings of the pivotal study, although this new probe by the EMA will not instil much confidence.
Brilinta was originally touted as a blockbuster with peak sales expected to reach around $2 billion, but growth has been slow with sales in the third quarter reaching just $75 million, up marginally from the $65 million in the second quarter.
This has been disappointing as the pill was meant to turn around the fortunes of AZ, which has slashed R&D jobs over the past three years as it suffers from major patent expiries and an eroded pipeline, which has seen a slew of costly late-stage failures eventually claiming the job of its previous chief executive, David Brennan.
This is why the Anglo-Swedish firm does not want to give up on its medicine, and has been pursuing an aggressive sales strategy to help increase revenue.
This includes using the British science and universities minister David Willetts to argue that the NHS must use Brilinta - known as Brilique in the country - or face losing AZ staff in the UK.
He took the highly unusual decision in January to say that he wants the NHS: “To increase its use of [Brilique], amid mounting political concern about the drugs company’s commitment to British jobs.”
A warning from history
This is not the first time PLATO data has been questioned, as the FDA delayed its approval of the drug twice in 2010 after sending a complete response letter to AZ asking for more data from the study.
The US regulator finally showed the green light to the pill in mid-2010 however, and it now has a licence for the prevention of heart attack and cardiovascular death in adult patients with acute coronary syndrome.
Brilinta now faces the prospect of succumbing to a similar fate as Sanofi’s Multaq, which was put under heavy scrutiny by regulatory bodies in 2011 after numerous safety concerns came to light.
The treatment which was originally licensed for certain patients with atrial fibrillation, was also once touted as a blockbuster when it was first approved in 2009, but as with Brilinta sales never really got off the ground and only reached $130 million by 2011.
Multaq was later restricted for use in a number of markets including Europe, further removing any chance it had of reaching that $1 billion sales mark. AZ will hope to avoid a similar outcome for its pill, given how much is riding on its success.
http://www.pharmafile.com/news/181478/ema-questions-brilinta-data?
This rounds off a tough few weeks for the firm as it comes after the US Department of Justice (DOJ) took the unusual decision to investigate the product in late October.
Neither AZ nor the DOJ have disclosed the exact nature of the investigation, but analysts believe it relates to various aspects of the study that have been criticised by external researchers.
This includes comments from James DiNicolantonio of Ithaca New York, and Ales Tomek of Charles University in Prague, who said in a recent paper that patients in the PLATO trial monitored by AstraZeneca were reported as benefiting more from taking Brilinta (ticagrelor) - than those monitored by an independent clinical research organisation.
Bernstein analyst Tim Anderson said in a research note this week that there could be ‘material downside’ for AstraZeneca if the DOJ investigation revealed serious flaws in the study.
AstraZeneca’s chief executive Pascal Soriot is not panicking yet, and said last week he was ‘very confident’ in the findings of the pivotal study, although this new probe by the EMA will not instil much confidence.
Brilinta was originally touted as a blockbuster with peak sales expected to reach around $2 billion, but growth has been slow with sales in the third quarter reaching just $75 million, up marginally from the $65 million in the second quarter.
This has been disappointing as the pill was meant to turn around the fortunes of AZ, which has slashed R&D jobs over the past three years as it suffers from major patent expiries and an eroded pipeline, which has seen a slew of costly late-stage failures eventually claiming the job of its previous chief executive, David Brennan.
This is why the Anglo-Swedish firm does not want to give up on its medicine, and has been pursuing an aggressive sales strategy to help increase revenue.
This includes using the British science and universities minister David Willetts to argue that the NHS must use Brilinta - known as Brilique in the country - or face losing AZ staff in the UK.
He took the highly unusual decision in January to say that he wants the NHS: “To increase its use of [Brilique], amid mounting political concern about the drugs company’s commitment to British jobs.”
A warning from history
This is not the first time PLATO data has been questioned, as the FDA delayed its approval of the drug twice in 2010 after sending a complete response letter to AZ asking for more data from the study.
The US regulator finally showed the green light to the pill in mid-2010 however, and it now has a licence for the prevention of heart attack and cardiovascular death in adult patients with acute coronary syndrome.
Brilinta now faces the prospect of succumbing to a similar fate as Sanofi’s Multaq, which was put under heavy scrutiny by regulatory bodies in 2011 after numerous safety concerns came to light.
The treatment which was originally licensed for certain patients with atrial fibrillation, was also once touted as a blockbuster when it was first approved in 2009, but as with Brilinta sales never really got off the ground and only reached $130 million by 2011.
Multaq was later restricted for use in a number of markets including Europe, further removing any chance it had of reaching that $1 billion sales mark. AZ will hope to avoid a similar outcome for its pill, given how much is riding on its success.
http://www.pharmafile.com/news/181478/ema-questions-brilinta-data?
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