Op­er­a­tions head Wyss ex­its No­var­tis, giv­ing way to new struc­ture and a string of pro­mo­tions

An­dré Wyss

No­var­tis $NVS is bid­ding farewell to a se­nior Swiss ex­ec, whose de­par­ture has trig­gered some re­struc­tur­ing and sev­er­al pro­mo­tions.

An­dré Wyss, cur­rent­ly pres­i­dent of No­var­tis Op­er­a­tions and coun­try pres­i­dent for Switzer­land, has de­cid­ed to step down on April 1 to “start a new chap­ter in his ca­reer.”

With op­er­a­tions be­ing split in­to tech­ni­cal op­er­a­tions and busi­ness ser­vices, his du­ties will be di­vid­ed be­tween three peo­ple: Matthias Leuen­berg­er takes over the coun­try pres­i­den­cy for Switzer­land; Stef­fen Lang as­sumes the role of glob­al head, No­var­tis Tech­ni­cal Op­er­a­tions; cor­po­rate af­fairs head Philippe Bar­rois leads the busi­ness ser­vices unit un­til the com­pa­ny iden­ti­fies a per­ma­nent suc­ces­sor.

In a state­ment, new CEO Vas Narasimhan gave a trib­ute to Wyss’ long his­to­ry with the com­pa­ny:

His jour­ney is unique: he has grown from a chem­istry ap­pren­tice in man­u­fac­tur­ing all the way to the Ex­ec­u­tive Com­mit­tee as the Pres­i­dent of No­var­tis Op­er­a­tions and Coun­try Pres­i­dent for Switzer­land. I want to thank An­dré for his lead­er­ship, his loy­al­ty to our com­pa­ny as well as his sig­nif­i­cant con­tri­bu­tions and busi­ness im­pact he had over the past three decades.

Re­flect­ing Narasimhan’s new pri­or­i­ties, No­var­tis has al­so ex­pand­ed San­doz gen­er­al coun­sel Shan­non Klinger’s role to chief ethics, risk and com­pli­ance of­fi­cer, and el­e­vat­ed her, tech­ni­cal op­er­a­tions head Lang, and chief dig­i­tal of­fi­cer Bertrand Bod­son to the ex­ec­u­tive com­mit­tee, or ECN.

Bertrand Bod­son

Bod­son, who joined the Swiss drug­mak­er (and the phar­ma in­dus­try) in Jan­u­ary, is a key fig­ure in the CEO’s vi­sion for No­var­tis to be­come a leader in all things dig­i­tal. In the past two weeks, No­var­tis has come out with two part­ner­ships in the nascent fields of pre­scrip­tion dig­i­tal med pro­grams and vir­tu­al clin­i­cal tri­als.

“The ap­point­ments of Bertrand Bod­son, Stef­fen Lang and Shan­non Klinger to the ECN will help us ac­cel­er­ate our ef­forts to lead in da­ta and dig­i­tal, in­crease our fo­cus on op­er­a­tional ex­e­cu­tion, and re­in­force our com­mit­ment to re­turn more to so­ci­ety than we take,” Narasimhan said.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Ko­dak's $765M deal is on hold un­til al­le­ga­tions are cleared — US gov­ern­ment

Just two weeks after Trump administration officials toured Kodak’s Eastman Business Park, signed a letter of interest for a $765 million loan designed to spur domestic pharmaceutical manufacturing on a socially distanced stage and posed for photos with the company CEO, they’re putting the deal on hold.

The US International Development Finance Corporation announced the halt in a brief tweet just before market closed, tanking the stock 7.64% within minutes. Kodak shares plunged 42.81% to $8.51 Monday in pre-market trading — still multitudes higher than where it was for years prior.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.