No­var­tis, Eli Lil­ly and Ab­b­Vie join grow­ing list of Big Phar­mas sev­er­ing ties with Rus­sia

Af­ter watch­ing the on­go­ing chaos of Rus­sia’s in­va­sion of Ukraine, a grow­ing line­up of the world’s biggest phar­ma gi­ants are tak­ing their next, close­ly watched steps amid a glob­al back­lash — pulling out of Rus­sia for a full slate of busi­ness ac­tiv­i­ties and, for some, hand­ing over prof­its on any­thing that re­mains.

The lat­est moves come af­ter crit­i­cism of phar­ma for fail­ing to stop do­ing busi­ness in Rus­sia — while many of the world’s busi­ness­es have been pulling a hasty re­treat out of Rus­sia as bombs fall in Ukraine.

No­var­tis told End­points News to­day that it’s tak­ing a two-fold re­sponse: an ini­tial $3 mil­lion do­na­tion to mul­ti­ple NGOs, and they “have de­cid­ed to sus­pend any in­vest­ments in Rus­sia and stop all com­mer­cial mar­ket­ing ac­tiv­i­ties, as well as all sci­en­tif­ic events, or­ga­nized by us or by ex­ter­nal par­ties.”

Mer­ck is fol­low­ing suit, telling End­points that they “will not make fur­ther in­vest­ments in Rus­sia.” The com­pa­ny al­so said that the com­pa­ny does not have re­search or pro­duc­tion fa­cil­i­ties in Rus­sia, and it is com­ply­ing with in­ter­na­tion­al sanc­tions to en­sure ac­cess to treat­ment. In ad­di­tion to halt­ing any new screen­ings and en­rolling pa­tients in on­go­ing clin­i­cal tri­als there, the com­pa­ny al­so has stopped plan­ning for new stud­ies.

Ab­b­Vie said in a state­ment that the phar­ma “has tem­porar­i­ly sus­pend­ed op­er­a­tions for all our aes­thet­ics prod­ucts in Rus­sia,” adding that the com­pa­ny has no man­u­fac­tur­ing plants in the re­gion and will con­tin­ue to mon­i­tor their em­ploy­ees in Ukraine and the sur­round­ing area.

For Eli Lil­ly, its re­sponse is two-fold: stop­ping the com­pa­ny’s ex­port of non-es­sen­tial med­i­cines in­to Rus­sia and do­nat­ing prof­its from Russ­ian sales to hu­man­i­tar­i­an re­lief or­ga­ni­za­tions.

An Eli Lil­ly spokesper­son clar­i­fied that the sus­pen­sion will tar­get cer­tain drugs like Cialis.

The com­pa­ny kept de­tails short, with a short blurb on its web­site say­ing, “We al­so have sus­pend­ed all in­vest­ments, pro­mo­tion­al ac­tiv­i­ties, and new clin­i­cal tri­als in Rus­sia, as well as the ex­por­ta­tion of non-es­sen­tial med­i­cines to that coun­try.”

Roche told End­points that since their Russ­ian col­leagues play a role in ac­cess to med­i­cine, the phar­ma will con­tin­ue its op­er­a­tions there for the time be­ing. The com­pa­ny has no pro­duc­tion sites in the coun­try. A spokesper­son added that new site ac­ti­va­tion and new pa­tient en­roll­ment is cur­rent­ly on hold in Rus­sia.

A spokesper­son for Bris­tol My­ers Squibb told End­points that “We have sus­pend­ed new pa­tient re­cruit­ments and clin­i­cal tri­al site ac­ti­va­tions in Ukraine, Be­larus and Rus­sia. We have al­so sus­pend­ed new clin­i­cal tri­al ac­ti­va­tions in those coun­tries.” And while the com­pa­ny has 160 em­ploy­ees in Rus­sia, there are no man­u­fac­tur­ing or R&D fa­cil­i­ties in the coun­try.

Pfiz­er, Bay­er and Sanofi were the first phar­mas to take the in­dus­try re­sponse to the in­va­sion one step fur­ther this week — with Pfiz­er stop­ping the start of new clin­i­cal tri­als in Rus­sia and halt­ing re­cruit­ment of new pa­tients in the coun­try in­to on­go­ing tri­als, even as it promis­es to con­tin­ue pro­vid­ing drugs to pa­tients al­ready en­rolled in stud­ies.

Bay­er an­nounced it would stop all spend­ing in Rus­sia and Be­larus not re­lat­ed to sup­ply­ing es­sen­tial prod­ucts in health and agri­cul­ture, and Sanofi said it will im­me­di­ate­ly stop all ad­ver­tis­ing and me­dia ac­tiv­i­ties in Rus­sia, as well as any new spend­ing not re­lat­ed to the sup­ply of “our es­sen­tial med­i­cines and vac­cines.”

But a num­ber of ma­jor com­pa­nies have yet to of­fi­cial­ly fol­low suit. So far, many have stuck with em­ploy­ee-fo­cused and/or hu­man­i­tar­i­an ef­forts.

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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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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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

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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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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