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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

Endpoints Premium

Premium subscription required

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

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

Endpoints Premium

Premium subscription required

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

Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.