No­var­tis fol­lows up on big CAR-T win by nam­ing Vas Narasimhan as its new CEO

No­var­tis, one of the world’s biggest spenders on drug R&D, will soon be run by a de­vel­op­ment ex­pert.

The phar­ma gi­ant an­nounced Mon­day morn­ing that Joe Jimenez is step­ping down in Feb­ru­ary and hand­ing the reins over to 41-year-old Vas Narasimhan, an ex­u­ber­ant ad­vo­cate of cut­ting-edge sci­ence who’s been mak­ing his mark with a slate of suc­cess­ful pro­grams for the com­pa­ny’s next wave of block­buster drugs.

Narasimhan is now join­ing one of the most ex­clu­sive clubs in bio­phar­ma — CEO of a bio­phar­ma or­ga­ni­za­tion with ac­tiv­i­ties that span the globe. In nam­ing him CEO, the Basel-based com­pa­ny is keep­ing an Amer­i­can at the top. But in­stead of the mar­ket­ing or le­gal back­ground of most of his peers, Narasimhan brings ex­pe­ri­ence in new prod­uct de­vel­op­ment.

His ap­point­ment came fast on the heels of an his­toric ap­proval of Kym­ri­ah (ti­s­agen­le­cleu­cel), the world’s first CAR-T ther­a­py, wide­ly cel­e­brat­ed as a key sci­en­tif­ic break­through with pro­found ther­a­peu­tic po­ten­tial.

But the de­vel­op­ment chief has al­so had some suc­cess with canakinum­ab, an an­ti-in­flam­ma­to­ry ther­a­py for heart dis­ease, along with new late-stage drug for mi­graine headaches part­nered with Am­gen, BAF312 (sipon­i­mod) for re­laps­ing mul­ti­ple scle­ro­sis, a slate of biosim­i­lars, and add-on da­ta for port­fo­lio ther­a­pies like the pso­ri­a­sis drug Con­sen­tyx.

To be sure, there have been set­backs along the way (sere­lax­in, for ex­am­ple). But Narasimhan has presided over one of the biggest pipelines in the busi­ness for the past 18 months and an R&D ef­fort that con­sumed $9 bil­lion last year alone.

In mak­ing the move, the en­gag­ing Narasimhan will al­so be work­ing close­ly with a board that has a rep for their rest­less search for cost ef­fi­cien­cies wher­ev­er they can be found. The com­pa­ny has lost a long stream of top tal­ent in the last few years, but it’s al­so re­cruit­ed a new gen­er­a­tion of sci­en­tists like Jay Brad­ner out of Dana-Far­ber.

The big ques­tion now is how Narasimhan will change things in R&D now that he has his hand on the tiller. Every new CEO in the busi­ness this past year — and we’ve seen a stream of them at GSK, Eli Lil­ly, Bio­gen and more — start­ed by re­struc­tur­ing their pipelines and ini­ti­at­ing a new round of deals. Now it’s Narasimhan’s turn to put his stamp on No­var­tis af­ter Jimenez has shunned big in­dus­try M&A — in a mar­ket where even mid-sized bolt-ons can look un­ap­peal­ing.

Narasimhan took the job pledg­ing that the com­pa­ny would con­tin­ue its glob­al ef­fort to nail down piv­otal da­ta on game-chang­ing drugs — the kind of ther­a­pies that can make a big dif­fer­ence for pa­tients, and earn bil­lions in rev­enue.

His state­ment:

We will con­tin­ue our lega­cy of bring­ing lead­ing in­no­va­tion to pa­tients around the world. With our re­cent launch­es, our strong pipeline, broad ca­pa­bil­i­ties, world-class lead­er­ship team, and com­mit­ted peo­ple, I am very con­fi­dent about our fu­ture.

Vas­ant Narasimhan at a Jan­u­ary 2017 news con­fer­ence in Basel Michele Lim­i­na/Bloomberg

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As biotech IPOs siz­zle on vir­tu­al Wall Street, 3 new play­ers roll the dice on meg­a­money gam­bles top­ping $325M

Back in early January when I interviewed Generation Bio CEO Geoff McDonough on his $110 million mega-raise, he was thinking in terms of taking another 12 to 18 months to get into the clinic and then filing an IPO. They were, after all, still preclinical after 4 years in the lab.

But with investors still clearly focused on biotech during the pandemic, a lot of things are going faster now. Including IPOing, which is sizzling for the right companies.

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Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seems to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

Ax­o­vant spin­out Arvelle ups Se­ries A haul, de­ploy­ing $200M-plus to com­mer­cial­ize epilep­sy drug in Eu­rope

One of the characteristic features of the sprawling biotech group Vivek Ramaswamy has built at Roivant is its ability to whip up big-money financing deals for its subsidiaries. Axovant was a prime example, raising $315 million in an IPO — a monster by 2015 and even today’s standards — with an Alzheimer’s pitch before a spectacular flop forced the company to replot its course directly and pivot to gene therapy.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.