AZ oncology drug a ‘Phoenix from the flames’
pharmafile | October 27, 2014 | News story | Sales and Marketing | AstraZeneca, CHMP, EC, lynparza, olaparib, oncology
As the possibility of a deal with Pfizer fades, AstraZeneca is continuing its argument for independence as a key cancer drug is recommended for use in Europe.
The CHMP has said that Lynparza (olaparib) should be used on the continent as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Briggs Morrison, executive VP of global medicines development and chief medical officer at AstraZeneca, says: “We are delighted that the CHMP has recommended Lynparza as a first-in-class treatment option for women with BRCA-mutated ovarian cancer and we look forward to the European Commission’s decision once it completes its review [a process that takes around three months].
“We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumour types including breast and gastric cancer.”
But the drug very nearly didn’t make it this far after it was ditched in 2011 given a string of poor trials results. It was revived by the new chief executive Pascal Soriot in 2012 as the firm reanalysed data on patients with a mutation of the BRCA genes.
Things have not gone so smoothly across the pond however, as the drug is still awaiting an FDA decision on its recommendation.
This comes after the US regulator decided it wanted more clinical trial data from the company before considering its approval. AZ is conducting a new study to try and appease the FDA’s concerns, and says this should be completed by the end of 2015.
The drug is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.
This new mechanism of action has generated much excitement among some analysts, although not all firms have made it work – key among them being Sanofi, which had to ditch its PARP inhibitor iniparib last year after it failed to prove its efficacy in a key trial.
Pfizer deal fades
In October the £32 billion deal that would have seen Humira manufacturer AbbVie buy UK-based Shire fell through after new tax rules in the US would have damaged the former’s ability to save money.
The whole deal was founded on the idea of a ‘tax inversion’ – whereby AbbVie would have bought Shire and moved its corporate HQ to Britain in order to pay less tax than it does in the US.
But the US Treasury has become displeased with such deals and is looking to stamp such activity out.
This now also means the potential $118 billion takeover of AZ by Pfizer, which the firm originally rejected back in May, will now most likely not go ahead as Pfizer would not be able to create a lucrative tax inversion from it.
AZ’s executives have from the beginning favoured independence from Pfizer, and have signed numerous deals with other groups and companies this year whilst also touting every pipeline update and regulatory approval – as proof that it can go it alone.
This recommendation will be a major boost for the firm given that the drug is expected to make peak annual sales of around $2 billion, should it gain approval in the US as well as the EU.
It also vindicates Soriot’s decision to bring the drug back into play, making this in addition a personal success for the company’s leader.
Ben Adams
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