Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech ex­pects to be $18.6B rich­er af­ter this year as Covid boost­ers churn out more da­ta. But it won't change much

Pfiz­er un­veiled the rich­es that its Covid-19 vac­cine is show­er­ing on it­self and part­ners at BioN­Tech when it pegged 2021 sales at $33.5 bil­lion. If the Ger­man biotech — which is in charge of de­sign­ing the cur­rent vac­cine and fu­ture mR­NA boost­ers — is right, it could be­come a ma­jor rev­enue pil­lar for years to come.

At its lat­est quar­ter­ly up­date, BioN­Tech fore­casts a €15.9 bil­lion ($18.6 bil­lion) cut for it­self by the end of the year, af­ter bag­ging €2.0 bil­lion ($2.4 bil­lion) in the first half.

The fu­ture BioN­Tech is out­lin­ing as a ma­jor mR­NA play­er of­fers an in­ter­est­ing con­trast with Mod­er­na, which has sig­naled it will chan­nel its overnight wealth in­to new bets on gene edit­ing and gene ther­a­py. Sure, there might be some deals to add com­bo can­di­dates, but BioN­Tech made it clear the plan is to fo­cus on in­fec­tious dis­ease and im­muno-on­col­o­gy, with a broad pipeline it’s al­ready start­ed putting in place, fea­tur­ing 15 pro­grams and 18 clin­i­cal tri­als.

Un­like Mod­er­na, BioN­Tech is al­so not shy­ing away from modal­i­ties out­side of mR­NA to get there — be it small mol­e­cule im­munomod­u­la­tors, an­ti­bod­ies, TCR cell ther­a­pies or bi­o­log­ics.

Re­it­er­at­ing what they see as a need to boost the two-dose reg­i­men with a third shot six to 12 months lat­er, ex­ecs say the best ap­proach would be to adopt the cur­rent vac­cine — which is based on the wild-type, an­ces­tral strain — for the boost­er.

Swap­ping out the strain for emerg­ing vari­ants is “tech­ni­cal­ly pos­si­ble” and would on­ly take about 100 days un­der the cur­rent set­up, CEO Uğur Şahin said. The team is al­ready run­ning a tri­al for the Be­ta vari­ant while launch­ing an­oth­er against the Delta vari­ant. But the key ques­tion is “when is the best time to change our plan” so that they don’t end up mak­ing a de­ci­sion that turns out to be wrong down the road.

He raised the ex­am­ple of in­fluen­za, where the WHO de­fines the rel­e­vant strain every year for vac­cine man­u­fac­tur­ers to fol­low in up­dat­ing their jabs.

“We do not yet have such a sit­u­a­tion for the coro­n­avirus,” he said. “And the chal­lenge at the mo­ment, the glob­al chal­lenge is that there are dif­fer­ent vari­ants on dif­fer­ent con­ti­nents. Even though the Delta vari­ant is dom­i­nat­ing North re­gion, there are oth­er re­gions like South Africa,” where the Be­ta vari­ant is more preva­lent.

Mean­while, BioN­Tech plans to keep “ac­cel­er­at­ing and broad­en­ing” the rest of the pipeline, with the re­cent ac­qui­si­tion of Gilead sub­sidiary Kite’s TCR plat­form as an ex­am­ple of how it might do that. On top of a man­u­fac­tur­ing site in Mary­land, that deal brought 50 cell ther­a­py ex­perts to BioN­Tech, in­clud­ing a cell ther­a­py pro­duc­tion crew and a per­son­al­ized neoanti­gen TCR re­search team.

When asked whether BioN­Tech would be look­ing to add a PD-1 drug to an­chor its I/O port­fo­lio — the on­ly ques­tion from an­a­lysts that was not about boost­ers — Sahin said it “could be an op­tion” if it fits the cri­te­ria.

We have, at the mo­ment, our own I/O mol­e­cules al­so with the PD-1 block­ade func­tion in de­vel­op­ment as you know, and an­ti-PD-L1 plus for the 41BB bis­pe­cif­ic is one of the pos­i­tives. And we have in­ter­nal pro­grams al­so ad­dress­ing ad­di­tion­al I/O pass­es. And in the next 12 to 18 months, we will cer­tain­ly come up with this deal, al­low­ing us to in­crease our pipeline to fur­ther gain com­bi­na­tion part­ners for the vac­cines and im­mune mod­u­la­tors that we have al­ready in placed.

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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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.”

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

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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