No­var­tis stacks more pos­i­tive PhI­II da­ta on Cosen­tyx fran­chise — eye­ing ap­proval in non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis

Days ago No­var­tis post­ed a brief note on pos­i­tive 16-week da­ta about Cosen­tyx’s ef­fects on non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis, open­ing the door to an EMA sub­mis­sion in the in­di­ca­tion. Now the phar­ma gi­ant says it has the 52-week win need­ed to take to FDA reg­u­la­tors, too.

The new up­date puts No­var­tis’ block­buster IL-17A drug on par with Eli Lil­ly’s ri­val ther­a­py, Taltz, for which sim­i­lar re­sults were re­port­ed in April. Both drugs are al­ready ap­proved for an­oth­er type of spondy­loarthri­tis, but this par­tic­u­lar form of in­flam­ma­to­ry arthri­tis does not show vis­i­ble ev­i­dence of dam­age on X-rays.

In the Phase III PRE­VENT tri­al, No­var­tis in­ves­ti­ga­tors want­ed to mea­sure the pro­por­tion of pa­tients achiev­ing an ASAS40 re­sponse — char­ac­ter­ized by at least 40% im­prove­ment in pa­tient glob­al as­sess­ment, pain, func­tion, and in­flam­ma­tion — ver­sus place­bo. Cosen­tyx notched a clear win both at the 16-week and 52-week time points, while al­so hit­ting all the sec­ondary goals in­clud­ing oth­er scores.

An OK for nr-axS­pA would mark the fourth in­di­ca­tion for Cosen­tyx and ex­tend its reach to a pa­tient pop­u­la­tion of up to 1.7 mil­lion pa­tients in the US and EU.

John Tsai No­var­tis

“These da­ta are en­cour­ag­ing for peo­ple liv­ing with nr-axS­pA, where there are on­ly lim­it­ed treat­ment op­tions avail­able,” John Tsai, head of glob­al drug de­vel­op­ment, said in a state­ment. “It’s a great ex­am­ple of how we’re work­ing to reimag­ine med­i­cine to help pa­tients re­al­ize ear­ly re­lief from this dis­ease.”

It is al­so an ex­am­ple of No­var­tis’ ag­gres­sive de­vel­op­ment plans for a grow­ing drug fran­chise that brought in $1.65 bil­lion in the first half of the year, fend­ing off ri­vals in a com­pet­i­tive field. Aside from Taltz, Valeant is push­ing Siliq — which tar­gets IL-17RA — while J&J has its own IL-23 drug, Trem­fya, for plaque pso­ri­a­sis. Cosen­tyx is al­so mar­ket­ed as a treat­ment for anky­los­ing spondyli­tis and pso­ri­at­ic arthri­tis.

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.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.

Per­pet­u­al cri­sis? Phar­ma com­mu­ni­ca­tions and pub­lic re­la­tions pros just wait for the next shoe to drop

Welcome to pharma public relations where every day feels like it might be a crisis.

More than three-fourths (76%) of pharma communications leaders expect to face three or more crises this year — compared to less than half (49%) of their peers in other industries, according to new survey from risk intelligence company Crisp. The same 76% also expect that a brand new risk that is yet to be identified will crop up this year, compared to 66% of peers across other industries who worry about the same thing.

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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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