France's NASH con­tender Gen­fit leaps on­to Nas­daq with $135M IPO

As it gears up for the late-stage read­out of its lead ex­per­i­men­tal NASH drug, France’s Gen­fit is vault­ing on­to the Nas­daq on Wednes­day with a $135 mil­lion IPO un­der the sym­bol $GN­FT.

The Lille-based com­pa­ny, which is al­ready list­ed on Eu­ronext Paris al­so as $GN­FT, spelled out the terms of the of­fer­ing on Tues­day.

The com­pa­ny de­cid­ed it want­ed a US list­ing to ex­pand its base in Boston, ac­cess the US tal­ent pool — con­sid­er­ing the ge­og­ra­phy is go­ing to be a large mar­ket for the drug (elafi­bra­nor) — as well a forge a clos­er con­nec­tion with US in­vestors, Gen­fit COO Dean Hum told End­points News.

NASH, which is typ­i­cal­ly as­so­ci­at­ed with obe­si­ty and di­a­betes, is set to eclipse he­pati­tis C as the lead­ing rea­son for liv­er trans­plants by 2020.

Gen­fit is of­fer­ing 6.15 mil­lion Amer­i­can De­posi­tary Shares priced $20.32 per ADS, and has con­cur­rent­ly se­cured a pri­vate place­ment of 500,000 or­di­nary shares in Eu­rope at €18.00 per share. In to­tal, the to­tal of­fer­ing is val­ued at rough­ly $135.1 mil­lion, be­fore com­mis­sions and ex­pens­es.

Gen­fit’s fu­ture hinges on the reg­u­la­to­ry fate of elafi­bra­nor for two main liv­er dis­or­ders: NASH and pri­ma­ry bil­iary cholan­gi­tis (PBC).

The big­ger, more lu­cra­tive in­di­ca­tion is NASH, an un­treat­ed fat­ty liv­er dis­ease that has rav­aged the de­vel­oped world and sparked a flur­ry of drug de­vel­op­ment from bio­phar­ma firms big and small. It is char­ac­ter­ized by a buildup of ex­cess fat in the liv­er that in­duces chron­ic in­flam­ma­tion and even­tu­al­ly cul­mi­nates in scar­ring that can lead to cir­rho­sis, liv­er fail­ure, can­cer and death.

While oth­er ma­jor NASH con­tenders — Gilead $GILD (fail in Phase III) and In­ter­cept $ICPT (mixed win in Phase III) — have dis­closed the top line num­bers of their late-stage tri­als, Gen­fit is ex­pect­ed to come out with its Phase III in­ter­im re­sults by the end of 2019.

When com­pared to its main ri­val, In­ter­cept, Hum as­sert­ed that elafi­bra­nor’s po­ten­tial in NASH res­o­lu­tion and re­duc­ing CV risk along with a be­nign safe­ty and tol­er­a­bil­i­ty pro­file set it apart.

Late-stage da­ta on In­ter­cept’s drug — obeti­cholic acid (OCA) — showed it in­duced a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in fi­bro­sis, but not NASH res­o­lu­tion, and a high­er-than-ex­pect­ed num­ber of pa­tients dropped out due to the pesky side-ef­fect of itch­ing.

“If you think about an­oth­er liv­er dis­ease, like say vi­ral he­pati­tis. The virus…dri­ves the fi­bro­sis for­ward in the liv­er. The way to treat vi­ral he­pati­tis is you get rid of the virus, and the fi­bro­sis gets bet­ter by it­self. So NASH is not any dif­fer­ent, what you want to is to treat the un­der­ly­ing cause of the on­set of pro­gres­sion of fi­bro­sis and that’s what elafi­bra­nor was able to demon­strate (in the phase IIb),” Hum said.

Up­on the read­out of OCA’s piv­otal study last month, In­ter­cept said it would ap­ply for mar­ket­ing ap­proval based on the dataset. Al­though Gen­fit’s piv­otal read­out comes at the end of the year, which will mean that its mar­ket­ing ap­pli­ca­tion (as­sum­ing the tri­al is pos­i­tive) will cer­tain­ly come af­ter In­ter­cept. But Hum is not wor­ried.

“The drug is well po­si­tioned to be­come stan­dard-of care,” he said, em­pha­siz­ing that elafi­bra­nor has the abil­i­ty to low­er CV risk (the lead­ing cause of mor­tal­i­ty in NASH pa­tients are CV events) and that its mech­a­nism of ac­tion is such that it could treat the widest NASH pa­tient pop­u­la­tion — from ad­vanced late-stage pa­tients to ear­ly-stage pa­tients with less fi­bro­sis.

Dubbed the silent dis­ease, it is hard to di­ag­nose in the ear­ly stages, mak­ing it dif­fi­cult to es­ti­mate its preva­lence, but stud­ies show that it af­flicts up to 12% of the adult pop­u­la­tion in de­vel­oped coun­tries. Al­though there are no ap­proved drugs for the dis­ease, the size of the NASH mar­ket is ex­pect­ed to cross $20 bil­lion by 2025.

“NASH by and large is the liv­er man­i­fes­ta­tion of liv­er dis­ease — it is a mul­ti­fac­to­r­i­al dis­ease with dif­fer­ent facets to it…like oth­er meta­bol­ic dis­eases — type II di­a­betes for ex­am­ple…NASH is very sim­i­lar, I think NASH will prob­a­bly be op­ti­mal­ly man­aged clin­i­cal­ly by com­bi­na­tion ther­a­py,” Hum said, adding that if ap­proved, elafi­bra­nor could eas­i­ly serve as the back­bone ther­a­py in fu­ture NASH com­bi­na­tion reg­i­mens.

Gen­fit is cur­rent­ly work­ing on get­ting its com­mer­cial op­er­a­tions ready in an­tic­i­pa­tion of the ap­proval. The com­pa­ny plans to re­tain the com­mer­cial rights to elafi­bra­nor in the key Eu­ro­pean coun­tries, and will like­ly pur­sue part­ner­ships with a glob­al phar­ma play­er in larg­er mar­kets like North and South Amer­i­ca, Hum said, adding that the com­pa­ny is in dis­cus­sions with dif­fer­ent groups about pric­ing.

“You’ve heard num­bers of $10,000 per year, here in the Unit­ed States — I think those num­bers are rea­son­able,” he said.

Mean­while, elafi­bra­nor is be­ing test­ed for use in oth­er liv­er in­di­ca­tions. In the com­ing weeks, the com­pa­ny is re­cruit­ing pa­tients for a study eval­u­at­ing the drug in pe­di­atric NASH pa­tients. Pos­i­tive mid-stage da­ta on the use of the drug in PBC — a rare and pro­gres­sive liv­er dis­ease — were an­nounced last De­cem­ber.

An­oth­er NASH hope­ful, the Mer­ck-part­nered NGM Bio­phar­ma, on Mon­day broke out the terms of its IPO. The com­pa­ny, which plans to list on the Nas­daq un­der the sym­bol $NGM, is of­fer­ing about 6.7 mil­lion shares priced be­tween $14 to $16, ac­cord­ing to the fil­ing.

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