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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,000+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,000+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

Endpoints Premium

Premium subscription required

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

Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

Endpoints Premium

Premium subscription required

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

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,000+ biopharma pros reading Endpoints daily — and it's free.

Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.