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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.