Results

Shire writes off a shot at long-acting hemophilia drug after small study flops

When Shire took over Baxalta, it acquired a program in development that used the technology from nearby Lexington, MA-based Xenetic Biosciences to stretch SHP656 into a long-acting drug with the potential for once-weekly dosing, or less, for hemophilia A.

But it didn’t work. And Xenetic’s stock plunged 30%.

Xenetic $XBIO says that in a Phase I/II study, conjugating polysialic acid to therapeutic blood-clotting factors with its platform tech had the right pharmacokinetic profile for an extended half-life rFVIII product. But it didn’t fit the bill for once-weekly dosing.

M. Scott Maguire

M. Scott Maguire, Xenetic’s CEO, conceded the failure, but thought he’d tout the technology in any case.

“We truly value our continuing relationship with Shire and look forward to exploring other potential applications of PolyXen within the Shire portfolio,” added Maguire.

Xenetic bagged a $10 million equity buy-in from Baxalta when it signed the original deal. And there was $100 million in milestones on the line, $3 million of which it grabbed at the beginning of this year.

Philip Vickers

“While Shire is disappointed by this outcome, the company is encouraged by the knowledge gained through this research and remains committed to transforming the treatment landscape for patients with bleeding disorders. Given the potential application of polysialic acid technology, the companies will explore future collaborations,” stated Philip Vickers, global head of research & development at Shire.


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RAPS Regulatory Convergence 2017