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

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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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)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

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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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

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

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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