Te­va inks $2.6B deal to buy in­to Re­gen­eron’s PhI­II NGF pain drug

Four months af­ter Re­gen­eron’s NGF pain med large­ly came through in a Phase II/III clin­i­cal tri­al, Te­va is pay­ing $250 mil­lion in cash to buy in­to the late-stage prod­uct while agree­ing to cov­er half the bil­lion-dol­lar de­vel­op­ment cost and split­ting fu­ture prof­its. A Re­gen­eron spokesper­son tells End­points News that the deal comes with $2.36 bil­lion in de­vel­op­ment and sales mile­stones.

Michael Aber­man, SVP of Strat­e­gy, Re­gen­eron

In the deal, Re­gen­eron $REGN will take the lead on US de­vel­op­ment of fas­inum­ab, with a chance to earn mile­stones along the way and lat­er shar­ing com­mer­cial­iza­tion du­ties. Te­va $TE­VA will take the reins on R&D and com­mer­cial­iza­tion out­side of the US. The drug is now in a Phase III study for os­teoarthri­tis pain while a mid-stage study is un­der­way for low­er back pain.

NGF drugs were all the rage un­til five years ago, when some of the pa­tients in clin­i­cal stud­ies be­gan to blow out their joints with meds de­signed to si­lence nerve growth fac­tors. The safe­ty is­sues side­lined the drugs, but de­vel­op­ers slow­ly worked out a plan to pro­tect pa­tients, and Pfiz­er got back in­to the clin­ic, with Eli Lil­ly sign­ing on to part­ner in a $1.8 bil­lion deal. J&J came back in right along­side, with fal­ranum­ab, in­li­censed from Am­gen.

Even though J&J had a huge Phase III ef­fort un­der­way, with four late-stage stud­ies, the phar­ma gi­ant de­cid­ed to aban­don the work ear­li­er this year, say­ing on­ly that it was repri­or­i­tiz­ing its pipeline.

For Re­gen­eron, the new part­ner­ship marks the lat­est in a string of high-pro­file col­lab­o­ra­tions. Its tie-up with Sanofi re­mains the phar­ma gi­ant’s biggest late-stage as­set. And Re­gen­eron seems to thrive on drug deals like this, en­joy­ing rapid­ly grow­ing rev­enue while con­tin­u­ing to make progress with its pipeline.

In this case, the drug­mak­ers see a ma­jor op­por­tu­ni­ty in com­ing up with a new way to con­trol pain aside from the opi­oids which have ad­dict­ed pa­tients around the world. Re­gen­eron’s lat­est study, though, al­so re­flect­ed a high place­bo ef­fect, un­der­scor­ing some old fears that have plagued the field for years.

Re­gen­eron, which suc­cess­ful­ly put a PC­SK9 drug through the clin­ic, is no stranger to ma­jor Phase III pro­grams like this. The boom­ing biotech ex­pects to re­cruit 10,000 pa­tients for the late-stage study, says Re­gen­eron’s Michael Aber­man, the VP of strat­e­gy, so the bil­lion-dol­lar price tag is not unique.

In this case Re­gen­eron is count­ing on some pre­clin­i­cal in­sights on this drug’s affin­i­ty to dif­fer­ent re­cep­tors “where we think ours is par­tic­u­lar­ly se­lec­tive,” Aber­man adds. But they won’t know un­til the end of Phase III just how this drug may dis­tin­guish it­self from the com­pe­ti­tion.

But the po­ten­tial mar­ket here is huge.

“It’s hard to pick up a news­pa­per with­out read­ing about opi­oid ad­dic­tion,” Aber­man tells me. And that il­lus­trates the kind of high lev­el in­ter­est in new non-opi­oid drugs like this that reach­es right up in­to the oval of­fice.

Said Re­gen­eron CSO George D. Yan­copou­los:

“The de­vel­op­ment of nov­el pain med­i­cines, such as fas­inum­ab, can be one im­por­tant step in com­bat­ing the grow­ing opi­oid epi­dem­ic. Fas­inum­ab rep­re­sents the cul­mi­na­tion of more than 25 years of Re­gen­eron sci­en­tif­ic work in neu­rotroph­ic fac­tors.”

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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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 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.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Ver­tex and CRISPR Ther­a­peu­tics un­veil more pos­i­tive gene ther­a­py da­ta, but busul­fan again casts a shad­ow over the field

Less than 12 hours after revealing a flop on its second shot for alpha-1 antitrypsin deficiency, Vertex plowed ahead with another data drop from its partnership with CRISPR Therapeutics. And though the topline proved positive, concerns over conditioning agents continue to linger over the collaboration, as well as the entire gene therapy space.

Presenting data from two trials at the European Hematology Association annual meeting, the pair announced that follow-up data of at least three months for 22 patients with genetic blood disorders indicated a “consistent and sustained” response to the experimental drug CTX001. All 15 patients with transfusion-dependent beta thalassemia did not need further blood transfusions and all seven with severe sickle cell disease were pain free, the biotechs announced.

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.