Covid-19 roundup: Gilead aims remde­sivir to­ward help­ing In­dia out­break; Mer­ck pairs with 5 In­di­an gener­ics man­u­fac­tur­ers for mol­nupi­ravir

As the num­ber of Covid-19 cas­es in In­dia dra­mat­i­cal­ly in­creas­es, Gilead will do­nate 450,000 vials of its remde­sivir drug to the gov­ern­ment.

The com­pa­ny an­nounced the move in a re­lease on Mon­day. Gilead is of­fer­ing tech­ni­cal as­sis­tance sup­port for new lo­cal man­u­fac­tur­ing fa­cil­i­ties and do­na­tions of APIs to scale up the pro­duc­tion of the drug — com­mer­cial­ly named Vek­lury — to help cut down on the re­cent surge.

Gilead has sev­en li­censees based in In­dia, and they all have scaled up batch size to in­crease sup­ply of the drug. The Cal­i­for­nia biotech has fo­cused on reach­ing low and mid­dle-in­come coun­tries with its drug. Remde­sivir has been au­tho­rized for tem­po­rary use as a Covid-19 treat­ment in 50 coun­tries, in­clud­ing the US.

On April 13, Gilead stopped its study of the drug in high-risk, non-hos­pi­tal­ized Covid-19 pa­tients, and cit­ed a lack of need, not safe­ty or ef­fi­ca­cy con­cerns. In­dia banned ex­ports of the drug as it saw case num­bers con­tin­ue to rise. Vek­lury is used in more than half of hos­pi­tal­ized pa­tients with Covid-19, the com­pa­ny said.

Mer­ck pairs with 5 In­di­an gener­ics man­u­fac­tur­ers for mol­nupi­ravir

In an ef­fort to keep up with the dev­as­tat­ing Covid-19 sit­u­a­tion in In­dia, Mer­ck has en­tered vol­un­tary li­cens­ing agree­ments with five In­di­an gener­ics man­u­fac­tur­ers to pro­duce mol­nupi­ravir.

The in­ves­ti­ga­tion­al oral an­tivi­ral is in Phase III to treat pa­tients who are not hos­pi­tal­ized. Pro­duc­tion of the drug, de­vel­oped with Ridge­back Bio­ther­a­peu­tics, is be­ing upped to in­crease ac­cess and sup­ply.

Cipla, Dr. Red­dy’s Lab­o­ra­to­ries, Em­cure Phar­ma­ceu­ti­cals, Het­ero Labs and Sun Phar­ma­ceu­ti­cal In­dus­tries are the five gener­ic man­u­fac­tur­ers, and all are equipped with WHO pre­qual­i­fied fa­cil­i­ties.

Phase II/III tri­al da­ta pro­vid­ed some mixed re­sults for the team at Mer­ck. Though mol­nupi­ravir did not in­di­cate any suc­cess pre­vent­ing deaths or short­en­ing stays in hos­pi­tal­ized pa­tients, the com­mu­ni­ty is hope­ful that the pill can work as a pre­ven­ta­tive mea­sure, keep­ing at-risk, new­ly di­ag­nosed Covid-19 pa­tients from end­ing up in the hos­pi­tal. The com­pa­ny re­ceived pos­i­tive signs from ear­ly tri­als, and it has moved in­to Phase III.

Mer­ck has al­ready scrapped 2 Covid-19 vac­cines and one drug. The lat­est drug, known as MK-7110 or CD24Fc, was canned af­ter it was ac­quired from On­coIm­mune. The drug faced man­u­fac­tur­ing and reg­u­la­to­ry de­lays, and Mer­ck said in a state­ment that the drug wouldn’t be avail­able un­til 2022.

US trade rep­re­sen­ta­tive meets with vac­cine mak­ers to talk in­tel­lec­tu­al prop­er­ty

As the pan­dem­ic rages on in some parts of the world, a US trade rep­re­sen­ta­tive has met with drug­mak­ers Pfiz­er and As­traZeneca to talk about a po­ten­tial in­tel­lec­tu­al prop­er­ty rights waiv­er, Reuters has re­port­ed.

Kather­ine Tai met vir­tu­al­ly with ex­ec­u­tives of the two com­pa­nies. Mem­bers of the World Trade Or­ga­ni­za­tion are set to talk about a pro­pos­al from In­dia and South Africa to waive the WTO’s Agree­ment on Trade-Re­lat­ed As­pects of In­tel­lec­tu­al Prop­er­ty Rights (TRIPS). The US, among oth­er coun­tries, has blocked the move, ac­cord­ing to Reuters.

If it hap­pens, the move could help close the gap be­tween de­vel­oped and de­vel­op­ing coun­tries’ ac­cess to med­i­cine. In ear­ly April, Tai crit­i­cized that gap, and called for sac­ri­fices “in times of cri­sis.”

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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