Meet the New Lantus, Same As the Old Lantus

February 26, 2015 Meet the new Lantus, same as the old Lantus

Jonathan Gardner

The good news for Sanofi is that the all-important extension of its insulin franchise, Toujeo, earned first-pass FDA approval. The bad news is that the regulator does not think it is much different from predecessor Lantus.

Toujeo’s failure to achieve a claim of hypoglycaemia benefit makes it look rather undifferentiated at a time when the French group must cut prices to preserve Lantus market share and prepare for the launch of competitors. With just 16 months left in the patent life of its biggest seller, Sanofi’s board will be handing incoming chief executive Olivier Brandicourt a challenging dossier when he assumes control in April.

Non-inferior, not superior

Lantus, a once-daily insulin, is the best-selling drug in the diabetes space and third-biggest pharma product in the world. Although it has withstood a test in novel offerings from Novo Nordisk, first with Levemir and then with the Europe-only product Tresiba, its patent estate will evaporate in mid-2016 when a judicial stay lifts on the launch of Eli Lilly’s biosimilar, Basaglar (Lilly needs diabetes foundation to remain firm, January 31, 2014).

To protect sales of its top franchise, Sanofi has developed Toujeo, a more concentrated depot formulation of Lantus’ active ingredient, insulin glargine, that has a slower and more sustained release. The objective was to achieve a flatter delivery curve to avoid insulin peaks that can lead to dangerous dips in blood sugar – most importantly, the nocturnal hypoglycaemia that can go unnoticed and result in greater complications.

Unfortunately for Sanofi, that objective was not demonstrated sufficiently to satisfy regulators. Without this claim on the US label - or indeed, mention hypoglycaemia data - it will be difficult to persuade physicians to switch patients from the old product to the new. And it will be even more difficult to persuade insurers to pay for it.

Sanofi shares were 2% lower at €87.45 in afternoon trading in Paris, amid strong broader European markets.

Premium product?

Sanofi's mishandling of the mounting pricing pressure on Lantus contributed to Chris Viehbacher’s sacking as chief executive, so Mr Brandicourt will need to quickly develop a Toujeo action plan as he makes his move from Bayer in Leverkusen to Sanofi in Paris over the next month (Bayer: We wish Mr Brandicourt well, February 26, 2015).

EvaluatePharma’s consensus forecasts sales of Toujeo at $1.3bn in 2020, falling short of the $1.6bn falloff in Lantus sales between 2015 and 2020.

In order to accelerate Toujeo uptake, Bernstein analyst Tim Anderson estimated that Sanofi will need to price it 15% below Lantus. In 2014 the annual cost per patient of Lantus was $3,544, according to EvaluatePharma’s Sales, Volume and Price analysis; a 15% discount on Toujeo would imply a price of $3,012, or $8.25 per day.

Sanofi told Bloombergthat it will price Toujeo at parity with Lantus – unless the company is planning substantial price discounts, over and above those now being offered on Lantus, in the current environment this constitutes a premium product.

To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @ByJonGardner on Twitter