Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lon­za, the Swiss CD­MO near­ing its quasqui­cen­ten­ni­al an­niver­sary, to be in the up­per ech­e­lon of the biotech man­u­fac­tur­ing in­dus­try.

But 2020 — as it was for many CD­MOs — was a spe­cial year even by Lon­za’s stan­dards. The com­pa­ny inked a deal to pro­duce 1 bil­lion world­wide dos­es of Mod­er­na’s Covid-19 vac­cine and tapped phar­ma vet Pierre-Alain Ruffieux to lead its op­er­a­tions, moves which have al­lowed Lon­za to make a myr­i­ad of oth­er deals that will con­tin­ue to ramp up its glob­al pro­duc­tion ca­pac­i­ty.

Pierre-Alain Ruffieux

In an ex­clu­sive in­ter­view with End­points News, Lon­za’s CCO Jean-Christophe Hyvert said the com­pa­ny has no plans to slow down any­time soon.

“A big piece of the ac­tiv­i­ty has been sur­round­ed around Covid, both in terms of sup­port­ing clients when we can, and when we have a dif­fer­en­ti­at­ed ad­van­tage in the COVID de­vel­op­ment ef­fort,” Hyvert said. “And we do that across mul­ti­ple clients.”

Lon­za’s foot­print in Covid-19 ther­a­peu­tics goes be­yond the Mod­er­na vac­cine agree­ment. The com­pa­ny has re­ceived some 200 in­quiries from biotechs across the globe and has pub­lic deals with five oth­er com­pa­nies for vary­ing treat­ment pos­si­bil­i­ties.

Be­yond Covid-19, Hyvert said Lon­za’s fo­cus in 2021 and be­yond will be on en­sur­ing its op­er­a­tions are up-to-date with the bur­geon­ing man­u­fac­tur­ing in­dus­try. Those in­dus­try trends, he said, are dri­ven by a mar­ket that cen­ters on a pipeline of strong new drug can­di­dates and an in­creas­ing glob­al pres­ence with­in that pipeline.

“The pipeline of new drugs is very strong, and the pipeline of new drugs is be­com­ing more and more glob­al,” Hyvert said. “So we are evolv­ing in terms of more drugs com­ing from dif­fer­ent ge­o­gra­phies, in terms of … more for­mats, (and) in terms of the speed to de­vel­op­ment and de­liv­ery is in­creas­ing. We need to re­spond to all of that, and that’s what we are do­ing.”

Tan­gi­ble ex­am­ples of that re­sponse have come in re­cent months, per­haps most no­tably through Lon­za’s ac­qui­si­tion of its first bi­o­log­ics man­u­fac­tur­ing in Chi­na as part of a deal with Cy­ti­va, an­nounced just two weeks ago. The near­ly 183,000-square-foot site in­cludes near­ly 70,000-square feet of lab space that will pri­or­i­tize an­ti­body de­vel­op­ment and man­u­fac­tur­ing ser­vices.

And in De­cem­ber, Lon­za an­nounced six dif­fer­ent man­u­fac­tur­ing and de­vel­op­ment col­lab­o­ra­tions with var­i­ous biotech out­fits, as well as a Visp, Switzer­land ex­pan­sion that will boost its pro­duc­tion ca­pac­i­ty by 30% by the first half of 2022.

“We are ex­pand­ing in Chi­na, es­pe­cial­ly on the bi­o­log­ics side. We’ve been in the coun­try for a few years, but we do be­lieve there is a very strong po­ten­tial in Chi­na,” Hyvert said. “(This) will pro­vide us a very com­pre­hen­sive, re­al-world cov­er­age with clin­i­cal and com­mer­cial ca­pa­bil­i­ties in … the Amer­i­c­as, Eu­rope and Asia, so that’s part of what we are do­ing. And at the same time, I think it’s im­por­tant to note that we are de­vel­op­ing the breadth of our of­fer­ings in terms of modal­i­ties.”

That ex­pan­sion of client-of­fer­ings seems to be three-tiered: mi­cro­bial ther­a­peu­tics, mR­NA tech­nolo­gies, and bio­con­ju­ga­tion. The Visp ex­pan­sions al­so seem to be the cen­ter of all three of these fo­cus­es, as they touch on mi­cro­bial de­vel­op­ment, while hous­ing pro­duc­tion sites for the Mod­er­na Covid-19 vac­cine that us­es mR­NA tech­nol­o­gy, and fi­nal­ly fo­cus­ing bio­con­ju­ga­tion ef­forts to make more com­plex pro­tein ther­a­pies.

“I think we have a unique of­fer­ing that helps both large phar­ma and small biotech with ei­ther their de­vel­op­ment needs or man­u­fac­tur­ing needs,” Hyvert said. “We are solv­ing more and more com­plex prob­lems for our clients, and I see that as be­ing very well re­ceived in the mar­ket­place.”

Go­ing for­ward, Hyvert said he ex­pects the cur­rent mar­ket trends of a strong drug pipeline with a glob­al fo­cus to stick around. Lon­za’s role, then, will be to con­tin­u­ous­ly re­spond and adapt to those trends to en­sure its ser­vices stay rel­e­vant and ef­fec­tive.

“I think we need to keep on build­ing on what dif­fer­en­ti­ates us, which is tech­ni­cal ex­per­tise, re­li­a­bil­i­ty, know-how, a wide range of of­fer­ings to re­spond to needs, our un­der­stand­ing of reg­u­la­tion and mar­kets to re­spond to costs, or to help cus­tomers to bring their drugs to mar­ket,” Hyvert said. “I think these fun­da­men­tal trends are not chang­ing, (so) I think the way we are ad­dress­ing them will be more and more im­por­tant.”

Here are Lon­za’s Covid-19 deals to keep an eye on:

  • Mol­e­cule: CAP-1002, cell ther­a­py can­di­date with Capri­cor for treat­ing Duchenne Mus­cu­lar Dy­s­tro­phy and com­pli­ca­tions aris­ing from COVID-19, treat­ment
  • In­tranasal vac­cine: Ad­COVID with Al­tim­mune
  • Vac­cine: Mod­er­na Covid-19 vac­cine, pre­vi­ous­ly known as mR­NA-1273
  • Mol­e­cule: AZD7442 with As­traZeneca, a com­bi­na­tion of two long-act­ing an­ti­bod­ies
  • Ther­a­py: Lenzilum­ab an­ti-hu­man gran­u­lo­cyte macrophage-colony stim­u­lat­ing fac­tor, with Hu­mani­gen
  • Mol­e­cule: Li­cens­ing agree­ment for JS016, a GS Xceed Ex­pres­sion Sys­tem with Jun­shi Bio­sciences
Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.