Boehringer In­gel­heim en­lists an­oth­er vir­tu­al biotech part­ner for its for­ay in­to reti­nal dis­eases

Boehringer In­gel­heim is bet­ting on reti­nal ther­a­pies in its lat­est deal and, in do­ing so, shin­ing the spot­light on a lit­tle-known biotech that has some new ideas about the kinds of dis­eases one can treat by tamp­ing down in­flam­ma­somes.

Clive Wood

In­flam­ma­some Ther­a­peu­tics’ key con­tri­bu­tion to the co-de­vel­op­ment and li­cens­ing pact — which its big Ger­man part­ner is re­serv­ing $160 mil­lion for — is a tech­nol­o­gy that de­liv­ers drugs through in­ject­ing a long-act­ing, biodegrad­able gel for­mu­la­tion in­to the eye. The com­pounds will come from Boehringer’s grow­ing reti­nal dis­ease pipeline port­fo­lio.

So far the com­pa­ny has on­ly paint­ed its reti­nal pro­grams in broad strokes, mak­ing it clear that it’s in­ter­est­ed in every­thing from age-re­lat­ed mac­u­lar de­gen­er­a­tion to di­a­bet­ic retinopa­thy to di­a­bet­ic mac­u­lar ede­ma with lead pro­grams in Phase II. These are block­buster in­di­ca­tions that have earned con­sid­er­able rev­enue for Re­gen­eron (Eylea) and No­var­tis (Lu­cen­tis) while spurring new biotechs to come up with new ap­proach­es.

Why In­flam­ma­some? Clive Wood, who leads dis­cov­ery re­search at Boehringer In­gel­heim, said they liked the nov­el in­trav­it­re­al tech­nol­o­gy as well as the sci­en­tif­ic team, led by co-founders Jayakr­ish­na Am­bati and Paul Ash­ton. Am­bati is a pro­fes­sor at the Uni­ver­si­ty of Vir­ginia while Ash­ton helped in­vent an eye im­plant for vi­su­al im­pair­ment and uveitis.

“This will en­able us to de­vel­op a broad range of nov­el ther­a­py op­tions for the many pa­tients with reti­nal dis­eases wait­ing ur­gent­ly for bet­ter and new ther­a­py op­tions,” Wood said in a state­ment.

While In­flam­ma­some is de­vel­op­ing its own mol­e­cules — dubbed ka­mu­vudines — for mac­u­lar de­gen­er­a­tion along­side Alzheimer’s, mul­ti­ple scle­ro­sis and type 2 di­a­betes, they ap­pear not to be part of the deal.

Boehringer has been trav­el­ing to dif­fer­ent cor­ners of the biotech world to get its hands on some cut­ting-edge, but rel­a­tive­ly low cost, in­no­va­tion. Just a few weeks ago, it struck a deal to cre­ate a vir­tu­al re­search cen­ter de­vot­ed to KRAS with in­ves­ti­ga­tors at MD An­der­son.

That in turn fol­lowed three oth­er deals, in­clud­ing hand­ing over $50 mil­lion for BBT-877, an ATX in­hibitor from Ko­rea’s Bridge Bio­ther­a­peu­tics, buy­ing out Gene­va-based can­cer vac­cine de­vel­op­er AMAL Ther­a­peu­tics for $358 mil­lion to­tal and ink­ing an $870 mil­lion NASH deal with Ko­rea’s Yuhan.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.