Nine block­buster drugs to watch are mak­ing their de­but, aim­ing at a $16B prize in 2021

The bio­phar­ma in­dus­try is front-load­ing block­buster drug ap­provals this year.

Clar­i­vate An­a­lyt­ics list­ed the 9 block­busters their an­a­lysts ex­pect to see ap­proved by the FDA this year, and on­ly 4 of them have yet to get the green light in ear­ly Q2, in­clud­ing No­vo Nordisk’s semaglu­tide, their GLP-1 drug for di­a­betes, and As­traZeneca’s PD-L1 check­point dur­val­um­ab.

It’s a new world in the pay­er com­mu­ni­ty, and the con­sen­sus peak sales pro­jec­tions seem to be fur­ther off the mark than ever as the com­mer­cial kick­back grows steadi­ly worse. But it is al­ways in­ter­est­ing to see what an­a­lysts be­lieve the big new drugs of the year are go­ing to be worth 5 years down the road.

In this case, as out­lined in the Drugs to Watch re­port, the to­tal is $16 bil­lion in an­nu­al rev­enue.


Top of the mark: Ocre­vus, the new MS drug from Roche with an es­ti­mat­ed rev­enue stream of $3.3 bil­lion in 2021. Right be­hind comes Dupix­ent, the stel­lar eczema break­through from Re­gen­eron and Sanofi, which is ex­pect­ed to hit $2.8 bil­lion.

Mer­ck KGaA makes the list — prob­a­bly for the first le­git­i­mate block­buster thumbs up in more than a decade — for their check­point avelum­ab, part­nered with Pfiz­er and now ap­proved to be sold as Baven­cio. They have the num­ber 4 check­point on the mar­ket, with As­traZeneca now poised to get 5th place.

But Clar­i­vate has As­traZeneca beat­ing out the more ad­vanced ri­val, pre­sum­ably cred­it­ing their shot at a com­bo ap­proach with the in-house CT­LA-4 check­point treme­li­mum­ab. In­creas­ing­ly, though, an­a­lysts are won­der­ing if PD-L1 and CT­LA-4 are such a good match, con­sid­er­ing the tox pro­file.

So re­mem­ber, these are just es­ti­mates. And 2021 is a long, long way away.

As usu­al, the phar­ma gi­ants dom­i­nate the list, but biotech is clear­ly play­ing a big role in the lead-up to com­mer­cial­iza­tion. Tesaro — the new PARP play­er — makes the list along with Re­gen­eron’s stand­out an­ti­body team. And this year In­cyte gets in­to the block­buster lane, with Eli Lil­ly, on the im­pres­sive baric­i­tinib, which is look­ing at a loom­ing PDU­FA date. Kite just bare­ly falls short of block­buster sta­tus on this list with its pi­o­neer­ing and new­ly filed CAR-T, but some­thing tells me they’ll give this one an ex­tra push to see if they can break the mark ear­li­er.

Lists rarely repli­cate each oth­er. Eval­u­atePhar­ma put to­geth­er their list of top drugs in the pipeline, and came up with 15 prospec­tive block­busters. Ei­ther way you look at it, though, it’s go­ing to be a bet­ter year than 2016, when the FDA record­ed OKs on on­ly 22 new drugs.

Check out their re­port, which al­so looks at the way sales are pro­ject­ed to build over the next 5 years. We’ll be keep­ing score.


Im­age: Shut­ter­stock

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Mer­ck halts prostate can­cer study while re­port­ing pos­i­tive read­out in bil­iary tract can­cer

Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.

An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.