Merck & Co and Pfizer’s four-year-old alliance in diabetes has reached fruition with the filing of three new products based on new SGLT2 inhibitor ertugliflozin.
The marketing applications – filed in the US and EU – cover ertugliflozin as a monotherapy, a fixed-dose combination of ertugliflozin and Januvia (sitagliptin), and a fixed-dose combination of the SGLT2 inhibitor and metformin.
Merck (known as MSD outside North America) and Pfizer have been working together on ertugliflozin’s development since 2013, but are late to the SGLT2 inhibitor party as there are already three other drugs in the class on the market.
The first SGLT2 inhibitor to be approved in the US was Johnson & Johnson’s Invokana (canagliflozin) in 2013, while in Europe it was AstraZeneca’s Forxiga/Farxiga (dapagliflozin) the previous year.
These were joined in Lilly/Boehringer’s Jardiance (empagliflozin) in 2014, along with several combinations in the intervening years.
With ertugliflozin reviews now ongoing at the FDA and EMA, the two partners are hopeful of approval by the end of the year, saying that the trio of ertugliflozin products will provide additional treatment options for type 2 diabetics.
Merck and Pfizer hope to close the gap with the leaders – and particularly fast-growing Jardiance – with a large-scale outcomes study for ertugliflozin to see if it can reduce cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, and hospitalization for heart failure.
The 8,000-patient VERTIS CV trial is due to report in 2019. A tougher pricing and reimbursement environment means cardiovascular outcomes data has become increasingly important for diabetes drugs, which need more than data on controlling blood sugar to lift themselves above their rivals in an increasingly crowded market.
Lilly and Boehringer’s EMPA-REG OUTCOME trial of Jardiance is a case in point, helping sales of the drug accelerate from a relatively low base last year and potentially adding $1.7bn to peak revenues for the drug, according to analysts at Evercore.
Meanwhile, J&J is scheduled to report outcomes data on Invokana later this year, while AZ and Boehringer’s trial is due to generate results in 2019. Merck and Pfizer insist ertugliflozin and its combinations offer “best-in-class” profiles that will help them make inroads into the market, and analysts at Credit Suisse seem to be of the same mind.
In a report issued last year they predicted $1.3bn in sales for the portfolio in 2020. J&J’s Invokana franchise brought in $1.4bn in sales last year, largely flat on the prior year, while AZ reported Forxiga sales of $832m (up 72%) and Jardiance rose 60% to $202m.