President Donald Trump, left, listens as Moncef Slaoui, a former GlaxoSmithKline executive, speaks about the coronavirus in the Rose Garden of the White House, Friday, May 15, 2020, in Washington. (AP Photo/Alex Brandon)

Mon­cef Slaoui piv­ots from Mod­er­na's board to the helm of Pro­ject Warp Speed. His task: Overnight suc­cess

Bioreg­num Opin­ion Col­umn by John Car­roll

Mon­cef Slaoui stepped off Mod­er­na’s board of di­rec­tors on Fri­day and piv­ot­ed straight in­to the high pro­file role head­ing the Trump ad­min­is­tra­tion’s Pro­ject Warp Speed, where he’ll be in charge of ac­cel­er­at­ing Mod­er­na’s — and oth­ers — vac­cines to a rapid re­lease for a pan­dem­ic weary world.

The news be­came of­fi­cial mid-day Fri­day af­ter nu­mer­ous re­ports ear­li­er that he had been picked off the short list of can­di­dates.

Slaoui’s role on Mod­er­na’s board earned a com­pen­sa­tion pack­age val­ued at $490,000 last year, some­thing con­sumer ad­vo­cates quick­ly fixed on as a con­flict of in­ter­est. It’s un­like­ly that crit­ics will be sat­is­fied by Slaoui’s res­ig­na­tion, though Mod­er­na has al­ready done quite well for it­self with­out any added help from Slaoui. The biotech has ben­e­fit­ed ex­ten­sive­ly from ma­jor sup­port from BAR­DA and the NIH and will con­tin­ue to en­joy close con­tacts in Wash­ing­ton, in­clud­ing at the FDA.

As the lead de­vel­op­er in the US of a new vac­cine, Mod­er­na al­so of­fers the White House a Boston-based com­pa­ny that can po­ten­tial­ly pro­vide a US hero to re­solve the pan­dem­ic. So it’s like­ly Trump’s fa­vorite play­er with or with­out Slaoui’s in­volve­ment.

Mod­er­na CEO Stéphane Ban­cel is part of a small band of vac­cines ex­ecs who be­lieves it’s pos­si­ble to do some­thing that would have been con­sid­ered im­pos­si­ble at the be­gin­ning of the year: hus­tle a new vac­cine straight through a Phase I-III pro­gram in a mat­ter of months and come up with just enough piv­otal ef­fi­ca­cy and safe­ty da­ta to start dis­tri­b­u­tion in the fall.

While bil­lions of peo­ple ea­ger­ly want that, there’s al­so been some sig­nif­i­cant push­back from a va­ri­ety of ex­perts in the field who won­der if it’s re­al­ly fea­si­ble to be able to field a Covid-19 vac­cine in less than 2 years — in it­self some­thing of a mir­a­cle in a sec­tor where de­vel­op­ment can take years and some­times decades.

Slaoui’s po­si­tion will have al­ready been mold­ed by his board post. And it will fit neat­ly in­to the ad­min­is­tra­tion’s own view that they can make it hap­pen. Speak­ing at the White House to­day, he men­tioned see­ing un­pub­lished da­ta — pre­sum­ably Mod­er­na’s — that sug­gest­ed suc­cess is close at hand, ac­cord­ing to Politi­co.

“These da­ta made me feel even more con­fi­dent that we will be able to de­liv­er a few hun­dred mil­lion dos­es of vac­cine by the end of 2020,” he said.

We won’t have long to wait.

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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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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.