Ab­b­Vie wins a 5-year free pass on mega-block­buster Hu­mi­ra in biosim set­tle­ment with ri­val Am­gen

It was clear from a re­cent sit-down with Leerink’s Ge­of­frey Porges that Ab­b­Vie was feel­ing good about keep­ing its mega-block­buster Hu­mi­ra fran­chise in the US to it­self through 2022. And this morn­ing we got a peek in­to why they were so bull­ish.

Richard Gon­za­lez

Am­gen, which scored the first ap­proval for a biosim­i­lar of Hu­mi­ra in the US, has signed off on a set­tle­ment agree­ment with Ab­b­Vie that will de­lay its roll­out un­til ear­ly 2023. Am­gen can get start­ed in the EU in the fall of next year, with a mar­ket­ing pact that calls on the com­pa­ny to pay roy­al­ties to Ab­b­Vie.

Ab­b­Vie’s shares $AB­BV shot up 6% this morn­ing.

The de­tails on this deal are be­ing kept un­der wraps, but the set­tle­ment re­moves one of the most liti­gious com­pa­nies in the in­dus­try from Ab­b­Vie’s pact. As Ever­cor­eISI’s Umer Raf­fat said in a quick note this morn­ing, the court dates over the patent fight could well have left any fi­nal ap­peals de­ci­sion un­til 2021.

Ab­b­Vie CEO Rick Gon­za­lez is ea­ger to make Hu­mi­ra in­to a $20 bil­lion a year drug be­fore hav­ing to com­pete against biosim­i­lars, and there are at least 10 oth­ers in the late-stage pipeline now with vir­tu­al­ly every­one in the gener­ic bi­o­log­ics busi­ness tack­ling the king of the mar­ket.

The FDA has be­come quite wel­com­ing to new biosim­i­lar ap­pli­ca­tions over the past year. But get­ting an ap­proval and carv­ing up mar­ket share at two com­plete­ly dif­fer­ent things, as Pfiz­er found out when it went af­ter J&J’s Rem­i­cade. Pfiz­er’s knock­off bare­ly made a dent in the mar­ket, and the phar­ma gi­ant re­cent­ly ac­cused J&J of us­ing im­prop­er meth­ods in bar­ring com­pe­ti­tion — a po­si­tion that J&J says was dri­ven by an em­bar­rass­ing in­abil­i­ty to mar­ket the ther­a­py prop­er­ly.

Ab­b­Vie, which has now de­layed the lead threat to its biggest cash cow for an­oth­er five years, was care­ful not to gloat this morn­ing.

Lau­ra Schu­mach­er, ex­ec­u­tive vice pres­i­dent, ex­ter­nal af­fairs, gen­er­al coun­sel and cor­po­rate sec­re­tary, Ab­b­Vie, had this to say:

In reach­ing this agree­ment, we have achieved the bal­ance be­tween pro­tect­ing in­vest­ment in in­no­va­tion and pro­vid­ing ac­cess to biosim­i­lars, which will play an im­por­tant role in our health care sys­tem. We will con­tin­ue to de­fend our in­tel­lec­tu­al prop­er­ty and to rein­vest in fur­ther ad­vance­ments in med­i­cine to bring choic­es to pa­tients in need.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

With lumasir­an on the FDA's doorstep, Al­ny­lam reads out new PhI­II da­ta in PH1

Just over a month away from its December PDUFA date, Alnylam flaunted new data from two Phase III studies to back lumasiran in primary hyperoxaluria type 1 (PH1), a rare liver condition.

The Cambridge, MA-based biotech snagged a priority review for the candidate back in June, and got positive feedback from the EMA’s Committee for Medicinal Products for Human Use just last week. Lumasiran uses RNA interference (RNAi) to silence the gene for glycolate oxidase, an enzyme used in the production of oxalate.

News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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