Belgium biotech argenx nabs Bayer speedy review voucher for a cool $98M

Bayer
(Bayer)

Big Pharma friend argenx has snapped up an FDA priority review voucher from Bayer for $98 million.

The little biotech, which has a series of deals across Big Pharma, will use the voucher, which can speed up the regulatory process for a new drug and get it approved more quickly, for its late-stage drug efgartigimod—but not in the indication you might think.

An FcRn antagonist, efgartigimod is on track to be filed in generalized myasthenia gravis in the coming weeks; however, argenx says it will not use its new voucher toward that filing. Instead, it “expects to redeem the PRV for a future marketing application” for the drug.

The experimental med is also in phase 3 testing for primary idiopathic thrombocytopenic purpura—a rare, often chronic disorder where IgG antibodies cause reduced numbers of platelets leading to an increased risk of bleeding and bruising—as well as midstage testing in chronic inflammatory demyelinating polyneuropathy and pemphigus vulgaris.

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“Efgartigimod has the potential to offer a new therapy option to patients with severe autoimmune diseases,” said Tim Van Hauwermeiren, CEO of argenx.

“We are currently advancing both an intravenous and subcutaneous formulation, which we believe will capture variability in patient preferences around dosing schedule and convenience, and will allow us to reach the most number of patients.

“Through this investment in a PRV, we’ll be able to seek expedited review of a future marketing application and build additional optionality into our development plans for efgartigimod.”

This comes after a spate of priority review vouchers changed hands between biotechs and pharmas from $100 million-plus. The vouchers can shave months off a typical approval, and thus add a few extra months of sales for companies. It’s also a quick cash grab for the firms that sell them on.