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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Publicis Groupe CEO Arthur Sadoun (L) is joined by actor Michael Douglas in a holiday message encouraging HPV vaccination (Publicis Groupe/YouTube)

Pub­li­cis for­goes light­heart­ed hol­i­day mes­sage for more se­ri­ous HPV warn­ing with celebri­ty guest

When is an annual holiday greeting more like a disease awareness ad? That’s the case in this year’s video from French-based advertising holding company Publicis Groupe featuring chairman and CEO Arthur Sadoun and his predecessor Maurice Lévy.

The typically jovial interaction between the two quickly takes a serious turn to HPV cancers and vaccines — along with a guest star appearance by actor Michael Douglas.

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