Af­ter near­ly two years of crit­i­cism from ac­tivists and White House, Mod­er­na un­veils a new plan for glob­al health

Mod­er­na, the tar­get of near­ly two years of crit­i­cism for its poli­cies around glob­al ac­cess to its Covid-19 vac­cine, an­nounced on Mon­day a new plan to ad­dress glob­al health.

The mR­NA biotech said it would launch a four-part pro­gram. First, it would put vac­cines in­to clin­i­cal test­ing for 15 pathogens that could ei­ther cause fu­ture pan­demics, such as Ni­pah virus or Zi­ka, or that pri­mar­i­ly af­fect the de­vel­op­ing world, such as tu­ber­cu­lo­sis and malar­ia.

Sec­ond, it would start a pro­gram called mR­NA Ac­cess to give re­searchers around the globe tools to man­u­fac­ture mR­NA for lab and an­i­mal stud­ies. And it will se­lect a site in Kenya for its planned African mR­NA man­u­fac­tur­ing plant, an­nounced ear­li­er to­day, which the com­pa­ny had pre­vi­ous­ly said would on­ly be some­where on the con­ti­nent.

Last­ly, Mod­er­na an­nounced that, for 92 low and mid­dle-in­come coun­tries, it will nev­er en­force its patents on its Covid-19 vac­cines, ex­tend­ing a lim­it­ed ver­sion of a promise it had made at the be­gin­ning of the pan­dem­ic.

“We must not as­sume that the COVID-19 pan­dem­ic will be the last pan­dem­ic that will im­pact glob­al health,” said CEO Stéphane Ban­cel. “Since our be­gin­ning, we have fo­cused on de­vel­op­ing a glob­al health vac­cine pro­gram and to­day, we are re­new­ing that fo­cus.”

The new moves come af­ter more than a year of crit­i­cism, ini­tial­ly from ac­tivists and NGOs but most re­cent­ly from the Biden White House, that Mod­er­na was not do­ing enough to make its high­ly ef­fec­tive Covid-19 vac­cine avail­able around the globe.

Some of those same ac­tivists wel­come Mod­er­na’s new moves, even if it didn’t go quite far enough in in­creas­ing im­me­di­ate vac­cine ac­cess.

James Love

“The promis­es they made — to me, they seem mean­ing­ful,” said James Love, di­rec­tor of Knowl­edge Ecol­o­gy In­ter­na­tion­al. “They’re clear­ly pres­sured by the White House and pressed by ac­tivists and oth­er peo­ple to do more than they’re do­ing.”

While As­traZeneca and J&J pri­or­i­tized low and mid­dle-in­come coun­tries with their shot, Mod­er­na ini­tial­ly sold the vast ma­jor­i­ty of its vac­cines to the US and oth­er wealthy na­tions.

Al­though it even­tu­al­ly pledged 500 mil­lion dos­es to Co­v­ax, the UN-backed body for eq­ui­tably dis­trib­ut­ing vac­cines, the biotech re­sist­ed calls to trans­fer its mR­NA tech­nol­o­gy to man­u­fac­tur­ing plants in oth­er parts of the globe that ac­tivists said might be able to pro­duce more shots.

Mod­er­na ex­ec­u­tives said they were a small biotech that didn’t nec­es­sar­i­ly have the staff to con­duct such com­plex trans­fers while al­so scal­ing up fa­cil­i­ties in the US and Eu­rope.  That ar­gu­ment had some trac­tion with vac­cine man­u­fac­tur­ing ex­perts but Politi­co re­port­ed that Biden ad­min­is­tra­tion of­fi­cials be­lieved Mod­er­na was more con­cerned with its bot­tom line: Com­pa­nies gen­er­al­ly sell vac­cines at cost in poor­er na­tions, rather than at a prof­it.

Mod­er­na’s new an­nounce­ment al­so elides an easy an­swer on the most high-pro­file ef­fort to scale up Mod­er­na’s vac­cine around the world. A WHO-backed team in South Africa has worked to re­verse-en­gi­neer the com­pa­ny’s shot to cre­ate a free and scal­able ver­sion.

Its di­rec­tor has said it would take one to two years with Mod­er­na’s help, but three to four years with­out it. And the le­gal sta­tus of the ef­fort was un­clear, giv­en that Mod­er­na had promised to not en­force its patents dur­ing the pan­dem­ic and Ban­cel had hint­ed the com­pa­ny may soon change its pos­ture.

Pe­ter May­bar­duk

Ac­tivists not­ed that al­though Mod­er­na’s new pledge in­cludes a promise to not en­force patents in 92 coun­tries, it does not in­clude South Africa, where the WHO ef­fort is un­der­way. And to the con­trary, Mod­er­na’s new state­ment says it ex­pects coun­tries out­side those 92 to “re­spect the Com­pa­ny’s in­tel­lec­tu­al prop­er­ty”

How­ev­er, Pe­ter May­bar­duk of Pub­lic Cit­i­zen said his un­der­stand­ing is that Mod­er­na will not stop pro­duc­tion of the WHO-backed vac­cine in South Africa. It will sim­ply stop them from sell­ing it there.

“It’s good,” he said. “Mod­er­na is step­ping out of the way as an ob­sta­cle.”

But lim­it­ing the mar­ket for the WHO ef­fort will al­so lim­it the com­mer­cial vi­a­bil­i­ty of any com­pa­ny that wants to man­u­fac­ture the re­verse-en­gi­neered shot, he said, po­ten­tial­ly un­der­min­ing the ef­fort.

”Mod­er­na still has not done what is most need­ed,” May­bar­duk said. That, he said, would be to ac­tive­ly help trans­fer its tech­nol­o­gy to the WHO and sci­en­tists in South Africa. “In­stead, we have Mod­er­na carv­ing up a map and try­ing to de­cide who can co­op­er­ate with who.”

Love not­ed that the 92 coun­tries al­so do not in­clude large swaths of Asia and Latin Amer­i­ca.

“It’s a rel­a­tive­ly con­ser­v­a­tive area for them,” he said.

Mod­er­na did not re­spond to ques­tions about how its new pol­i­cy will af­fect the South African ef­fort.

Mod­er­na’s new strat­e­gy in­cludes mul­ti­ple li­cens­ing plans, but nei­ther seems to cov­er them. The com­pa­ny said it would li­cense to oth­er man­u­fac­tur­ers as it be­gins fo­cus­ing on de­vel­op­ing new vac­cines, but on­ly “on com­mer­cial­ly rea­son­able terms.” And the mR­NA Ac­cess pro­gram on­ly cov­ers pre­clin­i­cal de­vel­op­ment — a stage where many re­searchers, al­though far from all, al­ready have ca­pa­bil­i­ties.

The new plant in Africa, which Mod­er­na ex­pects to even­tu­al­ly pro­duce 500 mil­lion dos­es of vac­cine per year, stands in con­trast to a BioN­Tech plan un­veiled last month. The Ger­man com­pa­ny said it would sup­ply ca­pac­i­ty in Africa by de­vel­op­ing portable fac­to­ries that can be built in Eu­rope and shipped to dif­fer­ent re­gions around the globe.

The plan to de­vel­op new vac­cines for po­ten­tial pathogens mir­rors calls from the NIH and oth­er groups to de­vel­op pro­to­type shots to guard against fu­ture pan­demics. In malar­ia and tu­ber­cu­lo­sis, Mod­er­na’s new ef­forts will com­pete against mR­NA shots al­ready in de­vel­op­ment from BioN­Tech.

Zachary Bren­nan con­tributed re­port­ing

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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