From Novartis, Bristol MS meds to new ADCs, here are 2020's blockbuster drug launches

Every year, new drugs enter the market, but only a select few come bearing blockbuster potential. For the 2020 crop, 11 are expected to cross the $1 billion annual sales threshold by 2024.

According to the Drugs to Watch in 2020 list compiled by Cortellis, these 11 would-be blockbusters span several therapeutic areas, including central nervous system (CNS), oncology, hematology, inflammatory diseases and metabolic disorders.

While these drugs may have novel mechanisms of action, more convenient dosing, better safety profiles or even curative potential, they are launching into highly competitive markets.

CNS has three entries. Novartis’ ofatumumab—marketed as Arzerra for chronic lymphocytic leukemia—and Bristol-Myers Squibb’s ozanimod are eyeing the crowded multiple sclerosis field.

For MS, there are already many oral meds, including Novartis’ old stalwart Gilenya and newly approved Mayzent, Biogen’s big seller Tecfidera and follow-on therapy Vumerity and Merck KGaA’s Mavenclad.

Ozanimod was a key pipeline drug at Celgene when Bristol acquired the Big Biotech for $74 billion. After an embarrassing refusal to file, the drug is scheduled to receive an FDA ruling by Mar. 25. If approved, its 2024 sales could reach $1.62 billion, according to Cortellis.

Ofatumumab, meanwhile, would be going directly up against Roche’s fast-growing Ocrevus, as both are anti-CD20 antibodies. Dubbed as the most successful launch in the history of Roche, Ocrevus generated sales of CHF 3.7 billion ($3.8 billion) in 2019, less than three years post-FDA nod. For ofatumumab, Cortellis projects 2024 sales of $1.26 billion in 2024.

The Novartis drug’s subcutaneous dosing could set it apart from Ocrevus’ intravenous infusion route. A group of physicians interviewed by SVB Leerink expressed across-the-board excitement over it. They view the med’s efficacy as on par with Ocrevus but with the convenience of self-administration.

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Between Bristol and Novartis, each has a second drug on the list. Liso-cel, an anti-CD19 CAR-T, is also one of three top prospects Bristol’s betting big on with its recent Celgene acquisition. The drug posted positive data showing a response rate in lymphoma that’s comparable to Gilead’s Yescarta and Novartis’ Kymriah, but with lower rates of adverse events than the figures researchers saw in the two marketed drugs’ studies.

Meanwhile, Novartis has a lot of proving to do with cholesterol med inclisiran, a PCSK9 blocker it paid $9.7 billion to access with its buyout of The Medicines Company. Although inclisiran boasts a less frequent dosing schedule, industry watchers doubt whether the Swiss drugmaker can justify the purchase price, given the disappointing performance of two existing PCSK9 therapies, Repatha and Praluent.

Outside of the BMS and Novartis MS candidates, the third CNS drug on Cortellis’ blockbuster potential list is Biohaven Pharmaceutical’s oral CGRP antagonist rimegepant for migraine. The CGRP arena is again quite competitive, with three injections—Amgen and Novartis’ Aimovig, Teva’s Ajovy and Eli Lilly’s Emgality—and one newly approved oral med in Allergan’s Ubrelvy.

Biohaven’s seeking an initial approval in acute migraine treatment, but it’s also hoping to break into the preventive setting, where those three injectables are competing. If approved, the drug’s sales could reach $1.03 billion in 2024, Cortellis says. The company’s even more reliant on rimegepant’s market success now that its lead glutamate asset, troriluzole, just failed a phase 3 study in generalized anxiety disorder.

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Cancer therapies also occupy three spots on this year’s roster. Besides liso-cel, two antibody-drug conjugates (ADCs) also made the cut.

Daiichi Sankyo and AstraZeneca’s Enhertu earned an early FDA nod late last year and was already launched in the U.S. by January. It’s approved for treating HER2-positive breast cancer after at least two prior regimens, but the pair hopes to enter earlier lines of use by running a head-to-head trial against Roche’s ADC Kadcyla. Other tumor types could also be on tap for Enhertu, including HER2-positive stomach, colorectal and non-small cell lung cancers, as well as HER2-low indications.

Daiichi U.S. chief Ken Keller recently told FiercePharma the company expects Enhertu's first-quarter sales to hit $18 million. Cortellis’ analysis now pegs the drug’s 2024 sales at $2.02 billion.

Immunomedics’ sacituzumab govitecan is the second ADC on the list. It targets the Trop-2 receptor that’s expressed on many solid tumors to deliver a chemo payload. After a manufacturing-related complete response letter in early 2019, Immunomedics has refiled the drug for triple-negative breast cancer after two prior therapies. A thumbs-up by June would kick-start a run-up to what could be $1.27 billion in 2024 sales, by Cortellis’ calculation.

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Novo Nordisk’s “holy grail” oral GLP-1 diabetes med Rybelsus also stands among the blockbuster crew. The drug already posted $7 million in sales in the fourth quarter of 2019 amid a small, targeted launch. While the injectable form of the drug, Ozempic, is already delivering blockbuster global sales, Rybelsus is widely viewed as a disrupter of the Type 2 diabetes landscape thanks to its oral status.

The Danish company plans to go into “strike mode” for full-on promotion as payer negotiations progress, CEO Lars Fruergaard Jørgensen previously said. Cortellis pegs Rybelsus’ sales at $379 million this year, rising to about $3.2 billion by 2024.

Remaining drugs on the list include Akebia Therapeutics, Mitsubishi Tanabe and Otsuka’s HIF-PH inhibitor anemia drug vadadustat, which competes against FibroGen, Astellas and AstraZeneca’s Evrenzo (roxadustat); Gilead’s rheumatoid arthritis contender filgotinib, which belongs to the same JAK inhibitor class as Pfizer’s Xeljanz, Eli Lilly’s Olumiant and AbbVie’s Rinvoq; and BioMarin’s hemophilia A gene therapy valrox that’s aiming to poach Roche drug Hemlibra’s market share.