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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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