Casual Andexxa disclosure hints at more Portola delays

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Portola often appears near the top of investors’ lists of likely biotech takeover targets, but based on its recent actions you might be excused for thinking that it was doing its best to lose this reputation.

True, part of its business is doing well: the anticoagulant Bevyxxa was approved and launched in the US despite yielding mixed clinical data. But the big problem is Portola’s equally valuable second asset, the factor Xa inhibitor reversal agent Andexxa, which is mired in an EU delay and which the company casually mentioned yesterday might be set back further in the US.

It is the nonchalant nature of Portola’s revelation that is perhaps most worrying. Presenting fourth-quarter financials yesterday the group’s chief executive, William Lis, revealed that on Friday the US FDA had asked for “data on some other patients in a randomised study ... in addition to the [open-label] Annexa-4” trial on which the current filing relies.

There was no separate announcement on this last week, so clearly the group had been advised that this request – which could result in a significant delay – was not material. The markets thought differently, sending Portola crashing 23% in today’s premarket, on top of the 6% the stock lost yesterday.

“Not much information”

“[The request] just came late last week,” Mr Lis told analysts. “We just thought at this time it was important for us to communicate it. I think we're just going to have to be patient and see what the discussions will be like over the next few weeks before we can comment further.”

However, he later admitted that Portola had thought it had ruled out the need to run a randomised clinical trial. Perhaps worst of all was the lack of clarity as to whether an extra study would have to be run before or after Andexxa’s approval. “We just don't have that information,” Mr Lis admitted.

The revelation makes for an anxious wait for investors in the run-up to the FDA’s May 4 PDUFA date on Andexxa. This action date had already been delayed by three months when the agency said it needed more time to review additional data submitted by Portola. The project also has an August 2016 complete response letter under its belt.

Andexxa’s approval in the EU is also in the lap of the regulators. Last week Portola said the CHMP had requested additional data relating to the Annexa-4 trial specifically with an April 2018 cut-off. This could delay a regulatory opinion until the fourth quarter.

Negative trend vote

There was also bad news last week for Bevyxxa, on which the EU regulator last week announced a “negative trend vote”, meaning that a positive recommendation was unlikely at this month’s meeting.

Andexxa carries 2022 sellside revenue forecasts of $749m, according to EvaluatePharma consensus, whereas Bevyxxa’s stand at $777m. The risk of delays with both assets explains why the group’s stock now stands 40% below where it was trading after Bevyxxa’s US approval last year.

Portola continues to hype Andexxa as potentially the first ever antidote for patients treated with factor Xa inhibitor anticoagulants who suffer a life-threatening bleed. Investors must wait to see if this comes to pass; talk of a takeover must surely also be off the table for now.

To contact the writer of this story email Jacob Plieth in London at jacobp@epvantage.com or follow @JacobPlieth on Twitter

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