7 block­busters: An­a­lysts spot­light 2022’s crop of drugs most like­ly to win top mar­ket­ing sta­tus — 2 drugs dom­i­nate

Every year, the analysts over at Clarivate issue their predictions for which drugs will hit blockbuster status.

Now in its 9th year, they’ve got some drugs — either pending an FDA approval or just won approval, in the case of the asthma treatment tezepelumab — that they think will become blockbusters (i.e. hit $1 billion in annual revenue) in the next five years. By the end of 2026, the analysts are expecting about $16 billion in sales from the top 7 drugs, and the top 2 candidates — both from Eli Lilly — are predicted to have an out-sized bite.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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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.

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Pfiz­er, BMS dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

CBO re­port high­lights ris­ing cost of brand-name drugs in Medicare as Con­gress con­sid­ers price ne­go­ti­a­tions

As the Democrats’ big shot at major drug pricing reform hangs in the balance, the Congressional Budget Office has released a new report showing the average net price of brand-name prescription drugs in Medicare Part D more than doubled from 2009 to 2018.

Overall, the average net price of a prescription — the cost after discounts and rebates given to private insurers and federal programs — fell from $57 in 2009 to $50 in 2018 in the Medicare Part D program and from $63 to $48 in the Medicaid program, according to the CBO’s latest prescription drug spending, use and pricing report. That partially reflects the increased use and falling average price of generic drugs.

FDA slams door to piv­otal tri­al for bub­ble boy dis­ease gene ther­a­py as Mus­tang Bio runs in­to an­oth­er hold

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

James Oliviero, Checkpoint Therapeutics CEO

As push to dis­rupt PD-(L)1 pric­ing heats up, Check­point trum­pets a piv­otal suc­cess

The crowded PD-(L)1 market has proven lucrative for biopharma’s earliest entrants like Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, but newer drugs have struggled to pry away market share. One strategy being undertaken by some biotech is to offer the drugs at a lower price, and one such company claimed it’s now one step closer to approval.

Checkpoint Therapeutics revealed topline pivotal data for its anti-PD-L1 antibody cosibelimab Tuesday morning, saying the candidate achieved a 47.4% overall response rate in metastatic cutaneous squamous cell carcinoma patients. The biotech has previously indicated it could offer the drug at a 20% to 30% discount from the usual $150,000 price tag.

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