Dicer­na scores broad, 'rest of liv­er' deal with No­vo Nordisk, bag­ging $225M in cash to hit some 30 tar­gets with RNAi plat­form

Turns out Dicer­na wasn’t done with deals yet af­ter lock­ing in $200 mil­lion up­front from Roche for a he­pati­tis B cock­tail two weeks ago.

Doug Fam­brough

No­vo Nordisk has signed on as the lat­est part­ner to its GalXC RNAi plat­form, hand­ing over $175 mil­lion in cash to claim any and all tar­gets of in­ter­est in liv­er-re­lat­ed car­dio-meta­bol­ic dis­eases that are not al­ready re­served in pre­vi­ous pacts. The Dan­ish drug­mak­er — which has sig­naled its in­ter­est to ex­pand con­sid­er­ably be­yond its core di­a­betes fran­chise in­to ar­eas like NASH — is al­so pur­chas­ing $50 mil­lion worth of Dicer­na’s eq­ui­ty at a 25% pre­mi­um of $21.93 per share. More re­search pay­ments and mile­stones ex­tend­ing to the bil­lions are on the line.

Dicer­na CEO Doug Fam­brough de­scribes the deal as a “cap­stone” for its part­ner­ing ef­forts in the liv­er space and a fur­ther sign that the biotech has en­tered a more ma­ture phase of part­ner­ing with in­creased scope and val­ue.

In a call with an­a­lysts and in­vestors fol­low­ing the an­nounce­ment, he adopt­ed a re­al es­tate anal­o­gy:

If you think of the liv­er as an is­land, there are in­di­vid­ual prop­er­ties on the is­land that we have part­nered — com­ple­ment with Alex­ion, a cou­ple of par­tic­u­lar tar­gets in NASH with BI, et cetera. The col­lab­o­ra­tion with No­vo has as its purview the rest of the land on the is­land that is not part­nered in any of the four ex­ist­ing col­lab­o­ra­tions and we will not be sell­ing any ad­di­tion­al re­al es­tates, so to speak, that No­vo could choose to de­vel­op. This al­lows new in­sights that come from hu­man ge­net­ics or frankly any source to in­spire No­vo to in­clude a tar­get in the col­lab­o­ra­tion.

Jim Weiss­man

Dicer­na is tasked with dis­cov­ery and pre­clin­i­cal can­di­date se­lec­tion on a num­ber of liv­er cell tar­gets for dis­or­ders span­ning chron­ic liv­er dis­ease, NASH, type 2 di­a­betes, obe­si­ty, and rare dis­eases. No­vo Nordisk has com­mit­ted to $25 mil­lion per year dur­ing the first three years. While the duo hasn’t dis­closed how many years they ex­pect the col­lab­o­ra­tion to run, the plan is to ex­plore around 30 through­out the pe­ri­od.

But Dicer­na’s am­bi­tions here go be­yond start­ing pro­grams for big­ger com­pa­nies to take over. It has ne­go­ti­at­ed an op­tion to opt in­to two drugs for more preva­lent ail­ments af­ter view­ing clin­i­cal da­ta gen­er­at­ed by No­vo — al­low­ing their clin­i­cal team to buy in­to suc­cess­es with­out bear­ing the cost, Fam­brough high­light­ed. Un­der the deal, it can al­so ini­ti­ate the de­vel­op­ment of two or­phan drugs that the big­ger part­ner can opt in to.

The “re­al­ly broad” col­lab­o­ra­tion is de­signed to fo­cus less on in­di­vid­ual genes than the po­ten­tial of dif­fer­ent com­bi­na­tion ap­proach­es in a num­ber of liv­er dis­eases, COO Jim Weiss­man said.

Bob Brown

In­ter­nal­ly, Dicer­na has been ap­ply­ing its plat­form rou­tine­ly to ex­am­ine a list of genes as­so­ci­at­ed with dif­fer­ent car­diometa­bol­ic dis­eases, ac­cord­ing to CSO Bob Brown.

“We just rou­tine­ly knock them out and then use the GalXC mol­e­cules we iden­ti­fied there to in­ter­ro­gate the gene func­tion in the rel­e­vant dis­ease mod­els that we run rou­tine­ly in house,” he said on the call. “There’s no di­rect align­ment of lists yet, but we’ve in­ter­ro­gat­ed ap­prox­i­mate­ly 40 genes this way in dif­fer­ent mod­els of car­diometa­bol­ic dis­ease.”

No­vo has yet to iden­ti­fy the genes that they would like to start with, but Fam­brough not­ed that the tar­gets they have ex­pressed in­ter­est in are still “very much avail­able.”

Adding to pre­vi­ous deals with Boehringer In­gel­heim, Alex­ion, Eli Lil­ly and Roche, the in­flux of cap­i­tal from No­vo should keep Dicer­na ful­ly fund­ed for at least a year af­ter the en­vi­sioned com­mer­cial launch of their lead pro­gram in pri­ma­ry hy­per­ox­aluria, the man­age­ment said.

So­cial im­age: AP Im­ages

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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