French drugmaker Sanofi has entered a collaboration and licence agreement with US-based Lexicon Pharmaceuticals to develop and commercialise sotagliflozin, which could be a potential treatment option for people with diabetes.
Sotagliflozin is an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2).
As part of the deal, Lexicon will receive an upfront payment of $300m and is eligible to receive development, regulatory and sales milestone payments of up to $1.4bn.
In addition, Lexicon is entitled to tiered, escalating double digit percentage royalties of net sales of sotagliflozin.
Sanofi executive vice-president Pascale Witz said: "This agreement with Lexicon reinforces our commitment to helping people living with diabetes.
"Adding sotagliflozin to our portfolio, which includes medicines at virtually every stage of the treatment pathway, highlights our focus on providing a large and diverse set of therapeutic options for people with this disease."
Currently, sotagliflozin is being evaluated in two pivotal Phase III trials in type 1 diabetes. Top-line results are expected during the second half of 2016.
The Phase III trials in type 2 diabetes are expected to be initiated next year.
In previous exploratory Phase II trials, sotagliflozin showed encouraging results, including reduction of blood sugar (HbA1c), improvement in glycemic variability and reduced meal-time insulin dose compared with placebo in type 1 diabetics.
The Phase II trials explored treatment in people with type 2 diabetes, including those with renal impairment, showed reduction of blood sugar (HbA1c), weight loss and blood pressure improvements.
"Adding sotagliflozin to our portfolio highlights our focus on providing a large and diverse set of therapeutic options for people with this disease."The deal will see Sanofi own exclusive worldwide licence to develop, manufacture and commercialise sotagliflozin, while Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes.
Lexicon will also retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialisation of sotagliflozin to treat type 1 diabetes in the US.
In addition, Sanofi will carry out all clinical development and commercialisation activities of sotagliflozin to treat type 2 diabetes worldwide and will be solely responsible for the commercialisation of the drug to treat type 1 diabetes outside the US.
Over the next three years, Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs, up to an aggregate of $100m.
Separately, the French firm has entered a worldwide licence agreement with Hanmi Pharmaceutical to develop a portfolio of experimental, long-acting diabetes treatments.
As part of the deal, Hanmi will receive an upfront payment of €400m and is eligible for up to €3.5bn in development, registration and sales milestones, as well as double digit royalties on net sales.
