New co-CEO named at WuXi; Bris­tol-My­ers gets pri­or­i­ty re­view for myelo­ma com­bo fea­tur­ing Em­plic­i­ti

Ed­ward Hu

→ Over the last 11 years, Ed­ward Hu has been COO, CFO and chief in­vest­ment of­fi­cer at WuXi AppTec. Now he’s been named co-CEO, with a spe­cial re­spon­si­bil­i­ty for small mol­e­cule drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing ser­vices, drug and med­ical de­vice test­ing ser­vices, plus some. He’s re­tain­ing his CFO re­spon­si­bil­i­ties for now un­til a re­place­ment is se­lect­ed. And Hu will con­tin­ue to re­port to com­pa­ny founder Ge Li, who’s been chiefly re­spon­si­ble for the rapid growth of the big Chi­na-based com­pa­ny.

→ Italy’s Dom­pé has got­ten the green light to mar­ket its top­i­cal eye drop in the US. Ox­er­vate, which treats a rare dis­ease called neu­rotroph­ic ker­ati­tis, con­tains a re­com­bi­nant form of the hu­man nerve growth fac­tor ce­negermin. Across two stud­ies, 70% of pa­tients treat­ed with the drug achieved com­plete corneal heal­ing in eight weeks, com­pared with 28% in the con­trol arm. “While the preva­lence of neu­rotroph­ic ker­ati­tis is low, the im­pact of this se­ri­ous con­di­tion on an in­di­vid­ual pa­tient can be dev­as­tat­ing,” said Wi­ley Cham­bers, an oph­thal­mol­o­gist in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, re­fer­ring to com­mon symp­toms like eye pain, in­flam­ma­tion and wa­tery eyes. “In the past, it has of­ten been nec­es­sary to turn to sur­gi­cal in­ter­ven­tions; these treat­ments are usu­al­ly on­ly pal­lia­tive in this dis­ease. To­day’s ap­proval pro­vides a nov­el top­i­cal treat­ment and a ma­jor ad­vance that of­fers com­plete corneal heal­ing for many of these pa­tients.”

→ The FDA is giv­ing Bris­tol-My­ers Squibb $BMY a push as it seeks to ex­pand us­age of Em­plic­i­ti in re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma. With the new pri­or­i­ty re­view, the com­pa­ny will get a fi­nal de­ci­sion by the end of the year on its com­bo use of Em­plic­i­ti, Cel­gene’s po­ma­lido­mide (Po­m­a­lyst, or Im­novid, de­pend­ing on where you are) and a low dose of the steroid dex­am­etha­sone. Bris­tol-My­ers, which is co-de­vel­op­ing the drug with Ab­b­Vie, filed the sup­ple­men­tal bi­o­log­ics li­cense ap­pli­ca­tion based on a Phase II study that showed adding Em­plic­i­ti to po­ma­lido­mide and dex­am­etha­sone — the cur­rent stan­dard of care — boost­ed me­di­an pro­gres­sion-free sur­vival by a no­table mar­gin.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

Presentations at the European Hematology Association began Friday, with Autolus Therapeutics revealing data they say continue to show the benefit of their CAR-T program.

The Autolus program, known as 0be-cel, achieved a 100% complete remission rate in a cohort of indolent B Cell Non-Hodgkin lymphoma patients, with all nine treated patients hitting the mark as of the May 17 cutoff. Another three patients are still awaiting treatment, while a fourth enrolled individual died due to a Covid-19 infection.

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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Verona signs Chi­na deal for PhI­II COPD drug; Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent in­fringe­ments on mi­graine drug

After a February Phase II win put Verona’s bad memories of a 2019 flop behind them, the company is now engaging in partnerships to ship out the experimental drug should it continue to produce positive results in Phase III.

Verona is teaming up with Nuance Pharma on a $219 million collaboration to commercialize ensifentrine in China, Macau Hong Kong and Taiwan, the companies announced Thursday. The deal includes $25 million in upfront cash and a $15 million equity stake in Nuance Biotech, the parent company of Nuance Pharma. Verona is eligible for up to $179 million in milestones.