No­var­tis gener­ics arm files for MS biosim­i­lar, chal­leng­ing Bio­gen; Pluris­tem short­ens name

No­var­tis’ gener­ics arm San­doz said it has sub­mit­ted ap­pli­ca­tions for a mul­ti­ple scle­ro­sis and Crohn’s dis­ease biosim­i­lar.

The drug is a biosim­i­lar for Bio­gen’s Tysabri, known gener­i­cal­ly as na­tal­izum­ab. Ac­cord­ing to San­doz, in pa­tients with re­laps­ing-re­mit­ting MS, the biosim­i­lar matched Tysabri in both ef­fi­ca­cy and safe­ty. Its BLA for the biosim­i­lar has been ac­cept­ed by both US and EU au­thor­i­ties, San­doz said.

Tysabri was first ap­proved in 2004 for re­laps­ing forms of MS, and then ap­proved in 2008 for Crohn’s dis­ease. The drug is one of the ear­li­est in Bio­gen’s suite of MS ther­a­pies. Bio­gen is al­so fac­ing slid­ing sales for its back­bone MS drug Tec­fidera due to gener­ic com­pe­ti­tion, and in March was de­nied a re­hear­ing af­ter it lost its ap­peal for a Tec­fidera patent late last year.

In 2021, Bio­gen made just over $2 bil­lion on Tysabri sales, and $1.95 bil­lion in Tec­fidera sales, down from $3.8 bil­lion the year be­fore.

San­doz said it would be pur­su­ing all in­di­ca­tions in which Tysabri is ap­proved for its biosim­i­lar ver­sion, which was de­vel­oped by Pol­phar­ma Bi­o­log­ics.

In oth­er news, ear­li­er this month, a San­doz spokesper­son ad­dressed ru­mors that No­var­tis might spin off its gener­ic arm, telling End­points News that No­var­tis would make that de­ci­sion by the end of the year. — Lei Lei Wu

Two weeks af­ter fail­ing late-stage mus­cle in­jury tri­al, Pluris­tem re­brands as Pluri 

A wind­ing road of at­tempt­ing to re­gen­er­ate mus­cles af­ter hip frac­ture surgery, treat res­pi­ra­to­ry is­sues in pa­tients with Covid-19, and ad­dress a host of oth­er dis­eases and hema­to­log­i­cal de­fi­cien­cies has led an Is­rael-based biotech to switch up its name.

The re­brand­ing comes at Pluris­tem Ther­a­peu­tics, or Pluri, as it now wants to be known by. Two weeks ago, the com­pa­ny’s in­tra­mus­cu­lar ad­min­is­tra­tion of al­lo­gene­ic PLX-PAD cells failed to meet the pri­ma­ry end­point in a Phase III study at­tempt­ing to treat mus­cle in­jury af­ter hip frac­ture op­er­a­tion.

The biotech al­so flamed out in the lung con­di­tion acute res­pi­ra­to­ry dis­tress syn­drome, in as­so­ci­a­tion with Covid-19 pa­tients, in a mid-stage study late last year.

Go­ing for­ward, Pluri will trade on Nas­daq as $PLUR in­stead of $PSTI. The rea­son­ing? Pluri is po­si­tion­ing ther­a­peu­tics as just a por­tion of its plans — food-tech, agri-tech, bi­o­log­ics and oth­er med­ical re­search all fall un­der the com­pa­ny’s am­bi­tions. That’s in­clu­sive of part­ner­ships aimed at “glob­al well­be­ing and sus­tain­abil­i­ty,” in­clud­ing team­ing up with Is­rael food pro­duc­er Tnu­va Group in Feb­ru­ary to cre­ate cell-based prod­ucts in the field of cul­tured meat via a new com­pa­ny 84% owned by Pluris­tem.

“Like our new lo­go’s dot-con­nect­ing arch sug­gests, it is time for Pluri to move from this sin­gle point to next gen­er­a­tion prod­ucts across a range of fields,” CEO Yaky Yanay said in a state­ment. — Kyle LaHu­cik

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.