#AS­CO18: Ab­b­Vie con­vinces one top an­a­lyst that its $6B 'megablock­buster' Ro­va-T is worth­less

Ab­b­Vie $AB­BV has man­aged to con­vince at least one promi­nent an­a­lyst that Ro­va-T is ab­solute­ly worth­less, as the com­pa­ny’s vi­sion of a $5 bil­lion earn­er grad­u­al­ly dis­solves.

Ge­of­frey Porges, Leerink

Ge­of­frey Porges at Leerink took a look at Ab­b­Vie’s for­mal pre­sen­ta­tion of its Trin­i­ty tri­al da­ta at AS­CO and came away shak­ing his head. His con­clu­sion:

The re­sults shown in the pre­sen­ta­tion were even worse than we had feared, and al­though Ab­b­Vie’s stock sold off much more than the val­ue of Ro­va- T af­ter the an­nounce­ment, we can’t help but re­gard the on­go­ing tri­als as large­ly fruit­less ex­er­cis­es. Fur­ther­more, the tox­i­c­i­ty sig­nal from the tri­al, along with the rel­a­tive­ly mar­gin­al ef­fi­ca­cy sig­nal, jus­ti­fies the com­plete elim­i­na­tion of all rev­enue as­so­ci­at­ed with Ro­va-T from our com­pa­ny fore­cast and val­u­a­tion for Ab­b­Vie. 

There was a lot to dis­like about the da­ta, he says, in­clud­ing the high 34% dis­con­tin­u­a­tion rate in the study; “49 or these 116 pre­ma­ture dis­con­tin­u­a­tions were due to pro­gres­sive dis­ease, with the oth­ers be­ing due to ad­verse events or oth­er undis­closed rea­sons.”

For the pri­ma­ry end­point over re­sponse rate, mea­sured by change in the tar­get le­sion, of the 301 evalu­able pa­tients (pre­sum­ably the oth­er 38 pa­tients were de­ceased or lost to fol­low up), the in­ves­ti­ga­tor-mea­sured re­sponse rate was 18%, in­creas­ing mod­est­ly to 19.7% in the DLL3 high group.

As mea­sured by the in­de­pen­dent re­view board,  the re­sponse rate fell to 12.4% for the com­bined pop­u­la­tion, and 14.3% in the DLL3-high pa­tients. And se­ri­ous ad­verse events in the drug group ran high.

Ab­b­Vie paid $5.8 bil­lion in cash for this drug, promis­ing up to $4 bil­lion more in mile­stones to ac­quire the lit­tle-known biotech uni­corn Stem­cen­trx. And with mon­ey like that on the ta­ble, ex­pec­ta­tions were run­ning high, fu­el­ing fore­casts that the phar­ma com­pa­ny could get past the even­tu­al loss of patent pro­tec­tion on Hu­mi­ra in style. Ab­b­Vie it­self pro­ject­ed peak sales at $5 bil­lion a year.

Porges’ con­clu­sion: The drug and the class look dead on ar­rival at AS­CO.

Ul­ti­mate­ly it seems un­like­ly in our view that Ro­va-T, or per­haps any vari­ant of DLL3 an­ti­body-drug con­ju­gate med­i­cine, will come to mar­ket, at least while the pro­file looks the way it did in TRIN­I­TY.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.