Boehringer In­gel­heim inks 'Sin­ga­pore's largest biotech deal,' promis­ing $1B each for a suite of an­ti-fi­brot­ic IL-11 drugs

The deep­er Boehringer In­gel­heim looks in­to Asian biotech, the more gems it seems to find. Hav­ing picked up new fi­brot­ic dis­eases drugs left and right, the Ger­man lega­cy phar­ma is bag­ging a slate of ex­per­i­men­tal ther­a­pies hit­ting an oft-over­looked cy­tokine in what’s be­ing billed as “Sin­ga­pore’s largest biotech deal.”

The tar­get of in­ter­est here is in­ter­leukin-11, or IL-11 — a “very tox­ic” pro­tein that caus­es tis­sue scar­ring and dam­age but was pre­vi­ous­ly (in­cor­rect­ly) thought of as pro­tec­tive and an­ti-fi­brot­ic, ac­cord­ing to Stu­art Cook, sci­en­tif­ic founder of En­le­ofen. The biotech is now el­i­gi­ble for $1 bil­lion in mile­stones for each an­ti­body pro­gram to emerge out of its pipeline cov­er­ing NASH, car­diac fi­bro­sis, id­io­path­ic pul­monary fi­bro­sis, and more.

Stu­art Cook, Jef­frey Lu and An­drew Khoo (En­le­ofen)

Click on the im­age to see the full-sized ver­sion

“(T)he old­er lit­er­a­ture was un­for­tu­nate­ly in­cor­rect but peo­ple be­lieved it,” Cook wrote in an email to End­points News. “While peo­ple were over­look­ing IL-11, we elu­ci­dat­ed its crit­i­cal role and broad­ened the re­search around the mech­a­nism across many dis­eases to build the broad­est IP port­fo­lio and know-how.”

Duke-NUS Med­ical School, where Cook di­rects the car­dio­vas­cu­lar and meta­bol­ic dis­or­der pro­gram, has been sup­port­ing the work with fund­ing from the Na­tion­al Med­ical Re­search Coun­cil. But as En­le­ofen ad­vanced the re­search and mapped a path to­ward the clin­ic, it be­gan look­ing for re­sources to back the hefty de­vel­op­ment pro­grams it en­vi­sioned, said di­rec­tor Jef­frey Lu.

Lu — a promi­nent fig­ure in Sin­ga­pore’s small but es­teeemed biotech cir­cle who al­so co-found­ed En­gine Bio­sciences — added that En­le­ofen is still con­tem­plat­ing its post-IL-11 fu­ture. An­drew Khoo, CEO of Tes­sa Ther­a­peu­tics, will al­so play a role in that as the third di­rec­tor along­side Lu and Cook.

Boehringer will now take over all clin­i­cal and reg­u­la­to­ry de­vel­op­ment as well as be­ing re­spon­si­ble for any com­mer­cial­iza­tion.

The En­le­ofen deal fol­lows a glob­al romp for Boehringer that saw it ink a $870 mil­lion NASH pact with South Ko­rea’s Yuhan and hand over $50 mil­lion for an au­to­tax­in in­hibitor from Ko­rea’s Bridge Bio­ther­a­peu­tics, with a fo­cus on IPF. Along the way it al­so re­served $160 mil­lion for In­flam­ma­some Ther­a­peu­tics and its long-act­ing, biodegrad­able gel for­mu­la­tion tar­get­ing the eye.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.