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Looking at recently approved drugs and the pipelines of major pharmaceutical companies, there is no lack of therapies that could potentially be significant revenue drivers.
Analytics company Clarivate, in its annual Drugs to Watch report, identified 15 drugs that have the potential to become blockbusters. The drugs are projected to hit blockbuster status — sales of $1B or greater — by 2027.
Drugmakers on this list include AstraZeneca (AZN), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (LLY), Gilead Sciences (GILD), Johnson & Johnson (JNJ), and Pfizer (PFE).
The report provides a dose of confidence to the pharma and biotech industries given that only 37 new molecular entities were approved in 2022, the lowest since 2016.
Although 2023 doesn’t promise to be a walk in the park, given patent cliffs and capital investment challenges, pharma and biotech “is on the cusp of unlocking revolutionary technologies that could greatly advance human health,” Clarivate said.
Here are some of the therapies Clarivate estimates have blockbuster potential.
Approved by the US FDA earlier in January, Leqembi, from Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALY), is poised to become a key treatment for early to mid-stage Alzheimer’s. The monoclonal antibody treat targets amyloid beta plaque in the brain to slow progression of the disease.
Leqembi is almost certain to become a blockbuster given one significant condition: CMS renders a positive National Coverage Determination, something the agency did not do for the companies’ other approved Alzheimer’s treatment, Aduhelm (aducanumab). CMS is likely to make that decision later this year. Should Leqembi be granted full approval — it currently has accelerated approval — it might aid CMS in rendering a positive decision.
Leqembi’s list price is $26.5K based on twice monthly infusions. Goldman Sachs has projected the treatment could reach $15.7B in global peak sales in 2035.
Approved in September 2022, Bristol-Myers Squibb’s Sotyktu is one of two treatments for plaque psoriasis to make the list. The other is UCB’s (OTCPK:UCBJF)(OTCPK:UCBJY) Bimzelx (bimekizumab), a dual IL-17 A/F inhibitor.
Sotyktu, a tyrosine kinase 2 (TYK2) inhibitor, was approved without a “black box warning,” which many analysts saw as a significant positive. They also viewed the approval as taking away market share from Amgen’s (AMGN) Otezla (opremilast).
Bristol (BMY) has previously stated Sotyktu could see $4B in peak sales assuming indications in other inflammatory diseases.
With several phase 3 trials ongoing, capivasertib, a selective ATP-competitive pan-AKT kinase inhibitor from AstraZeneca (AZN), could become a new treatment in the armamentarium for breast cancer. In 2022, the company reported that adding capivasertib to Fasdolex (fulvestrant) led to a 40% reduction in the risk of disease progression or death compared to Fasdolex alone.
Revenues could reach $3.8B by 2038, according to GlobalData.
GlaxoSmithKline’s (NYSE:GSK) daprodustat, a HIF prolyl-hydroxylase inhibitor for chronic kidney disease in patients on dialysis with anemia, has an FDA action date of Feb. 1. In October 2022, an agency advisory panel overwhelmingly voted in support of the candidate.
The drug works by promoting erythropoiesis, also known as red blood cell production.
Daprodustat has already been approved in Japan. Jefferies has estimated peak sales of $1B.
AbbVie (ABBV) is developing this new reformulation of the standard of care for Parkinson’s, carbidopa/levodopa. The medication is delivered by a subcutaneous pump.
Clarivate said that foscarbidopa/foslevodopa provides better efficacy than oral carbidopa/levodopa, has more flexible dosing, and a more convenient pump than current and potential competitors.