No Break For Sanofi: Seals Another Diabetes Deal
This article was originally published in Scrip
Having just secured a deal with Hanmi Pharmaceutical for its long-acting diabetes products, Sanofi has wasted no time in boosting its diabetes franchise again, by entering into an agreement with Lexicon Pharmaceuticals for sotagliflozin.
Sotagliflozin, an oral dual inhibitor of sodium glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), is being studied in two Phase III trials in type 1 diabetes, which are expected to report top-line results in 2016. Trials in the more common type 2 disease are expected to begin in 2016.
Under the agreement, Lexicon will receive an upfront payment of $300m and is eligible to receive development, regulatory and sales milestones payments of up to $1.4bn. Lexicon will continue to be responsible for all development activities for type 1 diabetes and will retain the option to co-promote in this indication, and plans to play a significant role, in collaboration with Sanofi, in its commercialization in the US.
In type 2 diabetes, Sanofi will be responsible for all clinical development and commercialization of sotagliflozin worldwide, and it will solely be responsible for the commercialization of the drug for type 1 diabetes outside the US. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to a total of $100m. Lexicon is also entitled to tiered, escalating double-digit percentage royalties on net sales of sotagliflozin.
Datamonitor Healthcare analyst, Rajan Sharma pointed out that this deal makes strategic sense for both companies. Sanofi, which has just admitted that sales of its diabetes franchise are set to fall over the next three years, required an oral option in its diabetes pipeline in order to compete with rivals, whereas Lexcion needed someone to collaborate with and fund it in order to move sotagliflozin to Phase III. The Hanmi deal involved injectable long-acting insulin and GLP-1 agonist products.
Previously sotagliflozin showed positive results in Phase II studies, including reduction of blood sugar (HbA
Sharma said that Lexicon believed sotagliflozin may be "efficacious in renally impaired patients," and if this is shown in the trials then it would a "key advantage held over other SGLT-2 inhibitors" as they are dependent on good renal function.
The main difference between the dual and the independent inhibitor is that the sotagliflozin inhibits not only the SGLT-1 receptors, found in the GI tract, but also renally expressed SGLT-2 receptors, therefore preventing glucose reabsorption in both the GI tract and kidneys. He added that the dual inhibitor could result in greater weight loss and reductions in blood glucose which an SGLT-2 inhibitor alone would not be able to do.
"There is also some evidence to suggest that inhibiting the SGLT-1 receptor results in secretion of the hormone GLP-1 which supresses appetite," Sharma said.
Sotagliflozin appears to be the most advanced dual SGLT inhibitor in development, but Novartis' candidate LIK-066 is also in development for type 2 diabetes with patients currently being recruited for a Phase II trial.