Paul Hudson, via Getty Images (Bloomberg)

Sanofi walks back Paul Hud­son’s promise of ear­ly vac­cine ac­cess for the US, French min­is­ters call it 'u­nac­cept­able'

Sanofi CEO Paul Hud­son’s com­ments yes­ter­day that the US will get first ac­cess to the com­pa­ny’s Covid-19 vac­cine, should it be ap­proved, were met with swift back­lash yes­ter­day in France, both from his own com­pa­ny and a mem­ber of the French gov­ern­ment.

First, hours af­ter Hud­son’s in­ter­view ap­peared on Bloomberg.com, Sanofi emailed jour­nal­ists a terse state­ments walk­ing back its CEO’s re­marks– sort of. The com­pa­ny said that while vac­cines from US pro­duc­tion will be main­ly pre­served for Amer­i­cans, pro­duc­tion ca­pac­i­ty else­where will sup­ply Eu­rope and the rest of the globe. The tech­nol­o­gy Sanofi us­es for its Covid-19 vac­cine can­di­date is pri­mar­i­ly man­u­fac­tured in the US, al­though the com­pa­ny said it is ex­pand­ing ca­pac­i­ty in ex­ist­ing fa­cil­i­ties in Eu­rope and else­where.

“We have al­ways been com­mit­ted in these un­prece­dent­ed cir­cum­stances to make our vac­cine ac­ces­si­ble to every­one,” they wrote. “Sanofi ben­e­fits from a di­ver­si­fied foot­print around the world. We have man­u­fac­tur­ing ca­pac­i­ty in the US, Eu­rope and all oth­er main re­gions. The US pro­duc­tion will be main­ly for the US and the rest of the man­u­fac­tur­ing ca­pac­i­ty will cov­er Eu­rope and the rest of the world.”

Then a French of­fi­cial ap­peared on a ra­dio show and called any plan to give Amer­i­cans first ac­cess “un­ac­cept­able.”

”For us, it would be un­ac­cept­able that there be priv­i­leged ac­cess for this or that coun­try on a pre­text that would be a fi­nan­cial pre­text,” ju­nior econ­o­my min­is­ter, Agnes Pan­nier-Runach­er, said on an in­ter­view with Sud Ra­dio.

Hud­son told Bloomberg on Wednes­day that “The U.S. gov­ern­ment has the right to the largest pre-or­der” of the ex­per­i­men­tal vac­cine be­cause a US agency, BAR­DA, has fund­ed its de­vel­op­ment. “It’s in­vest­ed in tak­ing the risk,” Hud­son said.

Hud­son’s com­ments en­tered in­to a sim­mer­ing bat­tle over who will get a vac­cine once it’s ap­proved. That bat­tle has par­tic­u­lar­ly cen­tered on the US and the Trump ad­min­is­tra­tion, which has poured over $1 bil­lion in­to top com­pa­nies de­vel­op­ing vac­cines but has es­chewed in­ter­na­tion­al co­op­er­a­tion — in­clud­ing an $8 bil­lion fund raised ear­li­er this month — in fa­vor of an in­ter­nal and thus far vague­ly de­fined ef­fort to get Amer­i­cans in­oc­u­lat­ed first.

The de­bate be­gan in earnest in March, when Reuters and a lead­ing Ger­man news­pa­per re­port­ed that the Trump ad­min­is­tra­tion tried to lure Ger­man mR­NA vac­cine com­pa­ny Cure­Vac to the Unit­ed States. Al­though Cure­Vac de­nied the re­ports, Ger­man sci­en­tists and of­fi­cials re­spond­ed with dis­may and ac­ri­mo­ny, con­demn­ing ef­forts for any coun­try to se­cure ex­clu­sive ac­cess to a vac­cine. The EU sub­se­quent­ly gave Cure­Vac an $89 mil­lion grant, in part to ex­pand man­u­fac­tur­ing on the con­ti­nent.

Since then, As­traZeneca has al­so promised some ear­ly ac­cess to the UK for the vac­cine its build­ing out of Ox­ford, while some world lead­ers have called for more uni­ver­sal ac­cess. To­day, UN­AIDS and OX­FAM re­leased a let­ter call­ing for a “Peo­ple’s Vac­cine” by which the WHO “es­tab­lish­es a glob­al and eq­ui­table rapid man­u­fac­tur­ing and dis­tri­b­u­tion plan – that is ful­ly-fund­ed by rich na­tions – for the vac­cine and all COVID-19 prod­ucts and tech­nolo­gies that guar­an­tees trans­par­ent ‘at true cost-prices.”

The lead­ing vac­cine man­u­fac­tur­ers are tak­ing ef­forts to dra­mat­i­cal­ly ex­pand ca­pac­i­ty, but ex­perts warn that any vac­cines will come in batch­es, rather than all at once.

BAR­DA, found­ed in 2005 to pro­tect the US from bi­o­log­ic threats, is fund­ing some of the world’s lead­ing Covid-19 vac­cine ef­forts, back­ing not on­ly Sanofi, but al­so putting around $1 bil­lion be­hind J&J and Mod­er­na’s ef­forts. Over the last 15 years, they have fund­ed both Sanofi and its re­com­bi­nant vac­cine sub­sidiary Pro­tein Sci­ences, which is mak­ing the Covid-19 vac­cine, to shore up ca­pac­i­ty to build a pan­dem­ic vac­cine. This spring, they in­vest­ed around $30 mil­lion be­hind the Pro­tein Sci­ences ef­fort.

Pro­tein Sci­ences’ re­com­bi­nant vac­cines are pri­mar­i­ly made at a BAR­DA-fund­ed fa­cil­i­ty in Pearl Riv­er, New York. The com­pa­ny’s BAR­DA-fund­ed man­u­fac­tur­ing fa­cil­i­ty in Swift­wa­ter, Penn­syl­va­nia will al­so be used. There is an ad­di­tion­al part­ner­ship with Uni­gen in Japan.

In his re­marks, Hud­son was crit­i­cal of Eu­rope for fail­ing to back pri­vate vac­cine ef­forts, call­ing the US and Chi­na a “mod­el” of pri­vate-pub­lic part­ner­ship and warn­ing, “don’t let Eu­rope be left be­hind.” The French phar­ma gi­ant said they are work­ing on ex­pe­dit­ing the process of get­ting vac­cines to Eu­rope.

“The co­op­er­a­tion we have with BAR­DA in the US al­lows us to ini­ti­ate pro­duc­tion as ear­ly as pos­si­ble while we con­tin­ue to de­vel­op and reg­is­ter the vac­cine,” Sanofi said. “In the mean­time, we are very en­cour­aged to see the mo­bi­liza­tion of the EU Com­mis­sion over the past weeks, ex­plor­ing sim­i­lar mea­sures that could ex­pe­dite both vac­cines de­vel­op­ment and ac­cess to the Eu­ro­pean pop­u­la­tion. We are hav­ing very con­struc­tive con­ver­sa­tions with the EU in­sti­tu­tions and the French and Ger­man gov­ern­ment amongst oth­ers.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Adar Poonawalla, Serum Institute of India CEO (Dhiraj Singh/Bloomberg via Getty Images)

Covid-19 roundup: Serum In­sti­tute eyes Africa for glob­al ex­pan­sion — re­port; Jun­shi an­tivi­ral hits pri­ma­ry end­point in late-stage tri­al

After Serum Institute CEO Adar Poonawalla announced last month that the world’s largest vaccine maker stopped producing doses of Covid-19 vaccines back in December, the institute is looking to expand.

The CEO told Reuters Monday that the company is considering establishing its first manufacturing plant in Africa in its next step toward global expansion after successfully mass producing and selling hundreds of millions of Covid-19 vaccine doses out of its India-based facilities.