Ursula von der Leyen, AP Images

Covid-19 roundup: EU calls on WTO mem­bers to ex­pand vac­cine and treat­ment man­u­fac­tur­ing; US re­moves DPA pri­or­i­ty rat­ings for As­traZeneca, J&J and Sanofi

The EU isn’t back­ing the US in its push to tem­porar­i­ly waive IP pro­tec­tions around Covid-19 vac­cines, but on Fri­day, the EU sub­mit­ted a new pro­pos­al to World Trade Or­ga­ni­za­tion mem­bers, seek­ing to lim­it the use of ex­port re­stric­tions and keep sup­ply chains open.

“Vac­cine-pro­duc­ing coun­tries should be ready to ex­port a fair share of their do­mes­tic pro­duc­tion,” the Eu­ro­pean Com­mis­sion said in a state­ment. “Sup­ply chains are high­ly in­ter­con­nect­ed and should not be dis­rupt­ed.”

The EU is al­so now en­cour­ag­ing vac­cine man­u­fac­tur­ers and de­vel­op­ers to ex­pand pro­duc­tion and en­sure the af­ford­able sup­ply of vac­cines to low- and mid­dle-in­come coun­tries.

“Such ac­tions could in­clude li­cens­ing agree­ments, the shar­ing of ex­per­tise, tiered pric­ing in­clud­ing non-prof­it sales to low-in­come coun­tries, con­tract man­u­fac­tur­ing and new in­vest­ments in man­u­fac­tur­ing fa­cil­i­ties in de­vel­op­ing coun­tries,” the EU said. The push comes as BioN­Tech and Pfiz­er, John­son & John­son and Mod­er­na have com­mit­ted to de­liv­er­ing 1.3 bil­lion dos­es this year to low-in­come coun­tries at no prof­it and to mid­dle-in­come coun­tries at a low­er cost.

But some close­ly fol­low­ing the new de­vel­op­ments weren’t im­pressed by the EU’s com­ments.

The EU al­so said that it’s tabling a ded­i­cat­ed com­mu­ni­ca­tion on in­tel­lec­tu­al prop­er­ty to the WTO body in charge of im­ple­ment­ing the Agree­ment on Trade-Re­lat­ed As­pects of In­tel­lec­tu­al Prop­er­ty Rights (TRIPS Coun­cil). “As re­gards the broad waiv­er pro­posed by a num­ber of WTO mem­bers, the Eu­ro­pean Com­mis­sion, while ready to dis­cuss any op­tion that helps end the pan­dem­ic as soon as pos­si­ble, is not con­vinced that this would pro­vide the best im­me­di­ate re­sponse to reach the ob­jec­tive of the widest and time­ly dis­tri­b­u­tion of COVID-19 vac­cines that the world ur­gent­ly needs,” the EU added.

US fi­nal­ly be­gins ship­ping do­nat­ed vac­cine dos­es around the world, DPA pri­or­i­ty rat­ings lift­ed for As­traZeneca, J&J and Sanofi

On Thurs­day, the US un­veiled its strat­e­gy for ship­ping 25 mil­lion J&J, Pfiz­er and Mod­er­na vac­cine dos­es by the end of the month, and less than 24 hours lat­er, the State De­part­ment spokesman tweet­ed out pho­tos of the first ship­ment of 1 mil­lion dos­es of the J&J vac­cine to South Ko­rea.

About 6 mil­lion dos­es will go to “re­gion­al pri­or­i­ties and part­ner re­cip­i­ents,” in­clud­ing Mex­i­co, Cana­da, and the Re­pub­lic of Ko­rea, West Bank and Gaza, Ukraine, Koso­vo, Haiti, Geor­gia, Egypt, Jor­dan, Iraq, and Yemen, and UN front­line work­ers, while near­ly 19 mil­lion dos­es will be shared through CO­V­AX, with the fol­low­ing al­lo­ca­tions:

    • About 6 mil­lion for South and Cen­tral Amer­i­ca, in­clud­ing to: Brazil, Ar­genti­na, Colom­bia, Cos­ta Ri­ca, Pe­ru, Ecuador, Paraguay, Bo­livia, Guatemala, El Sal­vador, Hon­duras, Pana­ma, Haiti, and oth­er Caribbean Com­mu­ni­ty (CARI­COM) coun­tries, as well as the Do­mini­can Re­pub­lic.
    • About 7 mil­lion for Asia to the fol­low­ing coun­tries:  In­dia, Nepal, Bangladesh, Pak­istan, Sri Lan­ka, Afghanistan, Mal­dives, Malaysia, Philip­pines, Viet­nam, In­done­sia, Thai­land, Laos, Papua New Guinea, Tai­wan, and the Pa­cif­ic Is­lands.
    • About 5 mil­lion for Africa, in co­or­di­na­tion with the African Union

In to­tal, the Biden ad­min­is­tra­tion says it’s plan­ning to ship at least 80 mil­lion US vac­cine dos­es glob­al­ly. But of that 80 mil­lion, 60 mil­lion As­traZeneca dos­es are still await­ing an FDA OK to be shipped be­cause they were pro­duced at the trou­bled Emer­gent BioSo­lu­tions plant in Bal­ti­more.

Mean­while, the US al­so re­moved the De­fense Pro­duc­tion Act pri­or­i­ty rat­ings for As­traZeneca, No­vavax, and Sanofi.

“While the man­u­fac­tur­ers will con­tin­ue to make these three vac­cines, this ac­tion will al­low U.S.-based com­pa­nies that sup­ply these vac­cine man­u­fac­tur­ers to make their own de­ci­sions on which or­ders to ful­fill first,” Jeff Zients, the White House Coro­n­avirus Re­sponse Co­or­di­na­tor, said at a press con­fer­ence on Thurs­day.

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

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.