Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House De­moc­rats in Wash­ing­ton and mem­bers of the Eu­ro­pean Par­lia­ment have now glommed on­to a ma­jor push by In­dia and South Africa at the WTO to abol­ish all IP around Covid-19 vac­cines.

At first blush, waiv­ing this IP sounds like an easy win: More Covid-19 vac­cines made lo­cal­ly for more peo­ple means more lives saved. Sim­ple enough, es­pe­cial­ly as low-in­come coun­tries have re­ceived just a tiny frac­tion of the world’s vac­cine al­lot­ment so far.

But when you be­gin to con­sid­er how this is sup­posed to play out in the re­al world, how the tech trans­fer will take time and en­er­gy and en­gage­ment from the very com­pa­nies that would lose their IP, how the le­gal chal­lenges and lo­gis­tics will com­pli­cate every­thing fur­ther, and how the man­u­fac­tur­ing site num­bers don’t re­al­ly make sense, it’s easy to won­der why there’s such a big push for this.

Take, for in­stance, Mod­er­na. Back in Oc­to­ber 2020, Mod­er­na an­nounced that it would not en­force its Covid-19 re­lat­ed patents against those mak­ing vac­cines in­tend­ed to com­bat the pan­dem­ic, even say­ing it would li­cense its IP.

Tahir Amin

Sounds great, but no one has come call­ing.

Some have not­ed that Mod­er­na doesn’t own every patent used in its vac­cine. Tahir Amin, an IP lawyer at the fore­front of push­ing for the waiv­er, al­so has ex­plained at length how man­u­fac­tur­ers need more than just the patents, say­ing oth­er vac­cine man­u­fac­tur­ers could scale up in about 6 to 8 months.

But where? What oth­er man­u­fac­tur­ers? Even Pfiz­er and Mod­era took longer than 6 to 8 months to re­al­ly ramp up.

The pub­li­ca­tion The In­ter­cept pro­posed to an­swer that ques­tion re­cent­ly in an ar­ti­cle ti­tled, “Fac­to­ry Own­ers Around the World Stand Ready to Man­u­fac­ture Covid-19 Vac­cines.” But the on­ly ex­am­ple pro­vid­ed is On­tario-based Bi­ol­yse Phar­ma, which said it can make 20 mil­lion vac­cines per year, and an­oth­er fill-fin­ish fa­cil­i­ty in Bangladesh that says it has ca­pac­i­ty.

So we’re go­ing to dis­rupt Pfiz­er and Mod­er­na, which to­geth­er are pro­duc­ing al­most 10 bil­lion dos­es of Covid-19 vac­cines over the next two years in fa­cil­i­ties that have been cleared by the top reg­u­la­tors in the world, so Bi­ol­yse can make 20 mil­lion dos­es in a year?

Even if there are hun­dreds of oth­er man­u­fac­tur­ing sites like Bi­ol­yse (which, by the way, was shut down by Health Cana­da in 2014) around the world, who’s go­ing to man­date the tech trans­fer, and who’s go­ing to en­sure the sites are built and per­form­ing prop­er­ly?

The US FDA isn’t cur­rent­ly con­duct­ing on­site for­eign in­spec­tions, and many low-in­come coun­tries don’t even have drug reg­u­la­tors. Cut­ting cor­ners on vac­cine man­u­fac­tur­ing can lead to se­ri­ous health is­sues, as we’ve seen with con­trac­tor Emer­gent’s site in Bal­ti­more, which is es­pe­cial­ly im­por­tant as these vac­cines are go­ing to healthy peo­ple.

Pres­i­dent Biden said Tues­day af­ter­noon that by Ju­ly 4, the US will do­nate 10% of its Covid-19 vac­cine stock­pile to the rest of the world. And ear­li­er this week, Mod­er­na pledged 500 mil­lion dos­es for low-in­come coun­tries. Biden’s chief med­ical ad­vis­er Tony Fau­ci told the Fi­nan­cial Times this week that while he’s ag­nos­tic on the waiv­er, he warned it could back­fire in­to a long le­gal bat­tle.

Right now, the cam­paign­ing for the IP waiv­er in the US seems to be a lot more about bash­ing Big Phar­ma than try­ing to ac­tu­al­ly in­crease vac­cine dos­es for the need­i­est. A long le­gal bat­tle with com­pa­nies like Pfiz­er and Mod­er­na isn’t go­ing to help bring the world more Covid-19 vac­cine dos­es.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

Four experts from the FDA’s Oncology Center of Excellence took to the New England Journal of Medicine yesterday to make the case for not only improving the agency’s ability to expeditiously pull dangling accelerated approvals when, on the rare occasion, confirmatory trials fail, but also better building “quality and efficiency into the AA on-ramp.”

The timely perspective arrives as Congress has exactly one week left to draft, release and sign off on the reauthorized user fee deals before layoff notices will be sent to drug reviewers. That package, which is likely to hitch a ride with the continuing resolution, may or may not include several policy riders (opposed by Republicans), including one that would allow the FDA to require confirmatory trials to be underway before an AA is granted, and would improve the process by which FDA can withdraw AAs.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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