3. AstraZeneca

AstraZeneca won FDA clearance for five novel molecules over the past five years, representing a net present value of $45.53 billion, according to a recent analysis by Evaluate Pharma. (AstraZeneca)

Approvals in past 5 years:
Value of recent approvals: $45.53 billion
Percent of value from recent approvals: 27.8%

When CEO Pascal Soriot joined AstraZeneca in 2012, the British pharma had been suffering from key patent expirations and needed fresh new meds. Fast forward to late 2018, and the drugmaker had managed to return to growth thanks to a group of new launches.

Some of AZ’s key saviors, such as cancer drugs Tagrisso and Lynparza, aren’t included in this report because they scored FDA approvals before 2016. But the company did get FDA clearance for five novel molecules over the past five years. Those drugs represent a total net present value of $45.53 billion, according to EvaluatePharma and Evaluate Vantage data.

One year stands out above the others for AZ. During 2017, the company took home FDA approvals for the PD-L1 inhibitor Imfinzi, blood cancer drug Calquence and asthma injection Fasenra. Each of those meds has either already reached blockbuster sales or has shown strong momentum on the way there.

For Imfinzi’s first FDA nod, the drug scored a conditional nod in previously treated bladder cancer. But after the med failed to move the needle in the phase 3 Danube trial in front-line metastatic bladder cancer, AZ in February withdrew that indication amid an industry-wide FDA review of accelerated approvals that haven't panned out in further testing.

Still, the bulk of Imfinzi’s $1.16 billion in first-half sales came from its use in stage III non-small cell lung cancer. Looking forward, AZ is eying other uses such as newly diagnosed metastatic (stage IV) NSCLC and front-line liver cancer. Evaluate currently pegs $22.3 billion to Imfinzi’s net present value.

As for Calquence, the drug is vying for share against AbbVie and Johnson & Johnson’s first-to-market BTK inhibitor Imbruvica in chronic lymphocytic leukemia. In a head-to-head trial, Calquence matched Imbruvica in terms of staving off disease progression in previously-treated CLL patients. It also showed a safety advantage as fewer Calquence patients experienced atrial fibrillation. The drug is worth $14.9 billion, Evaluate says.

RELATED: ASCO: AstraZeneca details Calquence's heart safety edge over Imbruvica as both brace for BeiGene's rival Brukinsa

Meanwhile, a newer BTK drug, BeiGene’s Brukinsa, will likely enter the CLL field soon. BeiGene recently trumpeted its own head-to-head win against Imbruvica with better tumor response performance by investigator analysis and fewer atrial fibrillation cases in second-line CLL. Further, Brukinsa’s front-line CLL trial is also on track to produce top-line data later this year.

Besides oncology, AZ is also focusing its efforts on respiratory and inflammatory diseases. In that class of meds, AZ in late 2017 introduced anti-IL-5 antibody Fasenra to treat asthma. In competition with biologics rivals including GlaxoSmithKline’s Nucala, Teva’s Cinqair, Sanofi’s Dupixent, and Novartis and Roche’s Xolair, Fasenra pulled in sales of $580 million in the first half of 2021, representing year-on-year growth of 32%.

AZ’s long-term plan for Fasenra includes testing its viability in inflammatory diseases large and small. Despite previous fails in COPD, AstraZeneca has identified a subgroup of patients with elevated blood eosinophil counts and recent exacerbations who may benefit from the treatment. It’s testing out that theory in the phase 3 Resolute trial. Evaluate analysts say the drug is worth $5.25 billion.

RELATED: AstraZeneca chases GSK, Sanofi and Regeneron with Fasenra trial win in nasal polyps

The other two AZ novel drugs that made it to the market in the past five years are hyperkalemia drug Lokelma, for which AZ got the FDA go-ahead in 2018 after two previous regulatory setbacks, and the Merck-shared Koselugo, which won approval last year to treat nerve sheath tumors in children with the rare neurological disorder neurofibromatosis type 1.

Those drugs are worth $2.3 billion and $724 million, respectively.

Some of AZ's other new meds aren't included in the report for various reasons. The company last year snagged an FDA green light for the three-in-one inhalation Breztri Aerosphere as a maintenance treatment for COPD. That's a combo of three existing drugs, so it's not included. Enhertu, the blockbuster-to-be HER2-targeted antibody-drug conjugate AZ licensed from Daiichi Sankyo, is also not counted in Evaluate's analysis because AZ doesn’t own the drug.

3. AstraZeneca