Pfiz­er racks up an FDA ap­proval for eczema block­buster hope­ful crisabo­role

Pfiz­er will now get a chance to see if the eczema drug crisabo­role is re­al­ly worth up to or be­yond $2 bil­lion in an­nu­al sales.

The FDA has ap­proved the non-steroidal top­i­cal PDE4 in­hibitor with an­ti-in­flam­ma­to­ry prop­er­ties, which Pfiz­er snapped up last May when it ac­quired Ana­cor Phar­ma­ceu­ti­cals for $5.2 bil­lion. The drug will be sold as Eu­crisa.

The drug came through back in mid-2015 in a pair of stud­ies which en­rolled more than 1,500 pa­tients, beat­ing out a place­bo and post­ing an ac­cept­able safe­ty pro­file.

Pfiz­er $PFE will have some heavy­weight com­pe­ti­tion in the field of atopic der­mati­tis. Re­gen­eron and Sanofi have lined up im­pres­sive Phase III da­ta for dupilum­ab, which has helped ex­cite an­a­lysts who are pro­ject­ing a multi­bil­lion-dol­lar peak sales fig­ure for the drug. Some op­ti­mistic buy-siders have pushed their peak es­ti­mates to $4 bil­lion or $5 bil­lion.

Pfiz­er has been busi­ly lin­ing up deals af­ter two at­tempts at a megamerg­er fell through with As­traZeneca and then Al­ler­gan. One of those deals in­clud­ed an $850 mil­lion up­front to part­ner with Mer­ck KGaA on its PD-L1 check­point. And the phar­ma gi­ant will­ing­ly paid a hefty pre­mi­um in clos­ing a deal to buy Medi­va­tion for $14 bil­lion ear­li­er this year.

“To­day’s ap­proval pro­vides an­oth­er treat­ment op­tion for pa­tients deal­ing with mild to mod­er­ate atopic der­mati­tis.” said Amy Egan, deputy di­rec­tor of the Of­fice of Drug Eval­u­a­tion III in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER).

Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Shutterstock

Biotech bears are maul­ing stocks as 2022 opens on a bleak note for in­vestors

As the first month of 2022 draws to a close, one thing seems to be on everyone’s mind in the biopharma world: a burgeoning bear market.

While inflation and supply chain issues have sent the Dow Jones and S&P 500 tumbling — and the Nasdaq entering correction territory — in recent weeks, few sectors have been hit as hard as biotech. The Nasdaq biotechnology index and the XBI, two prominent barometers of public biotech performances, are down 15% and 20% since the start of the year, respectively, outpacing each of the three major US indices’ downswings as of Tuesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Paul Stoffels, incoming Galapagos CEO (Michael Kovac/Getty Images)

Big Phar­ma R&D leg­end Paul Stof­fels is trad­ing his J&J ti­tle for the CEO role at one of the most deeply trou­bled biotechs in the in­dus­try

After 20 years working at the pinnacle of Big Pharma R&D, taking lead roles in J&J’s pipeline revamp and a quickly developed, one-shot Covid vaccine that is being sold around the world, it turns out the legendary Paul Stoffels has at least one more chapter ahead in his career.

And this one will be the biggest challenge the 59-year-old has faced yet.

After the market closed Wednesday, the longtime scientist was officially named as the new CEO of Galapagos, a troubled biotech trying to undergo a facelift in the wake of a disastrous alliance with Gilead that ended with the implosion of a drug program billed as one of the industry’s next big blockbuster stories.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

John Rim, Samsung Biologics CEO

Af­ter a ban­ner year, Sam­sung will charge for­ward with 'su­per plan­t' plans, and look to ex­pand abroad

Samsung Biologics’ future plans involve a lot of big, important, expensive buildings. And now, the company revealed in its Q4 earnings meeting, several of those expensive buildings, part of a massive “super plant,” will feature a heavy emphasis on mRNA, as the success and demand for Covid-19 vaccines continue to pay off.

Plant 5, the most recently announced building of its $2 billion “super plant,” will feature multi-modal mRNA, pDNA and viral vector product services, in addition to cell and gene therapies. That will be in addition to a vaccine drug substance manufacturing suite that’s expected to be ready to go at the already-erected facilities in Songdo within the “earlier part of this year,” Samsung said.

Sanofi’s US headquarters campus at 55 Corporate Drive in Bridgewater, NJ (Credit: CBRE)

As Sanofi keeps shrink­ing its US HQ foot­print dur­ing pan­dem­ic, new own­ers scoop up its old cam­pus

Sanofi’s US headquarters campus — still under lease for the next decade — has been sold as the pharma giant continues to downsize on-site during a pandemic that has forced a wholesale rethink of the way Big Pharma houses office staffers.

The REIT in charge of the sprawling campus in Bridgewater, NJ sold it off to new owners for $260 million. At one point, Sanofi — which has its world headquarters tucked into a Paris canton — occupied all 880,000 square feet of the 4-building complex. Now it’s down to 1, and shrinking.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.

Celeb couple Gabrielle Union-Wade and Dwyane Wade (shown with daughter) star again in Merck's vaccination campaign, this time advocating for older adults (Credit: Merck)

Celebri­ty cou­ple ac­tress Gabrielle Union and re­tired NBA star Dwyane Wade reprise roles in Mer­ck vac­ci­na­tion cam­paign

During the pandemic, pants are optional, but vaccines aren’t. That’s according to Merck’s latest TV spot to promote routine vaccinations, starring actress Gabrielle Union-Wade and her former National Basketball Association player husband, Dwyane Wade.

The “Don’t Skip” campaign initially focused on childhood vaccines — with Union and Wade’s children making cameo appearances — but this time the emphasis is on older adults.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 130,000+ biopharma pros reading Endpoints daily — and it's free.