No­var­tis-backed Io­n­is sub­sidiary Akcea maps a $100M IPO as it steers a lead drug to reg­u­la­tors

Paula Soteropou­los

Over the last three months Io­n­is sub­sidiary Akcea has ex­e­cut­ed a $1.65 bil­lion part­ner­ship with No­var­tis on two of its four drugs and mapped a path to reg­u­la­tors on both sides of the At­lantic af­ter its lead ther­a­py volane­sors­en suc­cess­ful­ly com­plet­ed a Phase III study. And now Akcea — a spe­cial­ist in lipid dis­or­ders — is shoot­ing for a $100 mil­lion IPO, with No­var­tis com­ing in to sup­port the move with an ex­tra $50 mil­lion to pur­chase a grow­ing eq­ui­ty stake.

Much of the val­ue in the IPO will be as­signed to volane­sors­en, which in­ves­ti­ga­tors says was suc­cess­ful in treat­ing rare cas­es of fa­mil­ial chy­lomi­crone­mia syn­drome. Found­ed in 2015, Akcea plans to go on to mar­ket volane­sors­en alone in the US and Eu­rope, with its part­ners at No­var­tis step­ping in on the next two ther­a­pies — AKCEA-APO(a)-LRx. and AKCEA-APOC­I­II-LRx — it plans to steer to reg­u­la­tors. No­var­tis first, though, has to de­cide if it wants to pick up op­tions for the drugs and pay for Phase III it­self.

Akcea is run by CEO Paula Soteropou­los, a long­time Gen­zyme vet who went on to Mod­er­na be­fore tak­ing the lead role at the sub­sidiary. Her to­tal com­pen­sa­tion was a hefty $7.8 mil­lion in 2015, when the sub­sidiary was start­ed in Cam­bridge, MA, and $3.4 mil­lion last year. Io­n­is cur­rent­ly owns all 73.8 mil­lion shares in Akcea, ac­cord­ing to the S-1.

Io­n­is, which has seen its stock rise and fall in a roller coast­er ride dri­ven by suc­cess­es and threats over the past year, will re­main the prin­ci­pal share­hold­er of the pub­lic com­pa­ny, which will re­ly heav­i­ly on volane­sors­en to make its case to in­vestors.

In the Phase III in­ves­ti­ga­tors re­port­ed a huge drop in triglyc­erides among the 33 FCS pa­tients tak­ing the drug, hit­ting the pri­ma­ry end­point. The place­bo arm saw the lev­el of triglyc­erides go up, help­ing to il­lus­trate the treat­ment ef­fect. The drug is de­signed to tack­le a dis­ease caused by hered­i­tary mu­ta­tions that in­hib­it the ac­tiv­i­ty of lipopro­tein li­pase, need­ed to break down triglyc­erides car­ried by chy­lomi­crons.

But re­searchers al­so not­ed that five pa­tients were forced out of the tri­al due to a threat­en­ing de­cline in platelet counts. Grade 4 throm­bo­cy­tope­nia oc­curred in three pa­tients, which end­ed af­ter they stopped dos­ing. There were no with­drawals due to platelet counts af­ter the com­pa­ny be­gan mon­i­tor­ing the side ef­fect, but the safe­ty is­sue did not pass un­no­ticed.

In No­var­tis’ orig­i­nal deal with Akcea in Jan­u­ary, the Big Phar­ma promised $225 mil­lion in near-term pay­ments, split be­tween fees, an up­front and an eq­ui­ty stake, and promis­ing $1.13 bil­lion more in de­vel­op­ment and com­mer­cial­iza­tion mile­stones.

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Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

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The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

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Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

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The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

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