Madrid, Nov. (Europa Press) - Sanofi and Lexicon Pharmaceuticals have signed a license and collaboration contract for the development and commercialization of Sotagliflozina, a new double oral administration inhibitor of sodium -glucose collection type 1 and 2 (SGLT-1 and SGLT-2), which could become a possible therapeutic option for people with diabetes.
"This contract with LEXICON reinforces our commitment to help people who live with diabetes. The incorporation of saotagliflozine into our product portfolio, which includes medications for practically each of the stages of diabetes treatment, confirms our effort to offerA broad and diverse set of therapeutic options for people suffering from this disease, "said the executive vice president of Sanofi, Pascale Witz, who will be responsible for directing the Global Diabetes and Cardiovascular Departments Care Business Unit in the new organizational structure of thecompany.
Currently, Sotagliflozine (LX4211) is being studied in two phase III pivotal tests for the treatment of type 1 diabetes, of which preliminary results are expected in the second half of 2016, and phase III tests in phase III tests are expected to beginPatients with type 2 diabetes in 2016. Sotagliflozine has already demonstrated promising results in exploratory studies (phase II) such as, for example, that reduces blood glucose, improves glycemic variability and decreases insulin needs in meals, inComparison with placebo, in people with type 1 diabetes.
Phase II studies in patients with type 2 diabetes, including patients with renal failure, showed that the drug reduced blood glucose, caused weight loss and improved blood pressure.In phase II program it was not observed that cawoglyflozine caused any increase in hypoglycemic episodes compared to base treatment.The profile of adverse events in the phase II program was similar to that of other products of this class and reflection of the urinary excretion of glucose associated with the inhibition of the SGLT-2 produced by the Sotagliflozine.
In fact, these results indicate that cassagliflozine could become an important option among oral antidiabetic medications and, also, offer solid foundations to continue research of this compound as a treatment for people with diabetes.
"Lexicon firmly believes in the potential of Sotagliflozine for patients living with diabetes. Our strategy has consisted of focusing our resources on the development of Sotagliflozine to treat type 1 diabetes and seek a valuable collaboration with which we could develop the drugTo treat type 2 diabetes, but only if this reinforced the value for stakeholders in a fully integrated diabetes program.
Up to 1.3 billion euros
According to the terms of the contract, Lexicon will receive a payment in advance of about 279 million euros --3 billion dollars-and may receive payments of up to about 1.3 billion euros-4 billion dollars-for the achievementsachieved in development, regulation and sales.Lexicon will also have the right to royalties of two staggered and ascending digits on net sales of Sotagliflozina.
For its part, Sanofi will obtain an exclusive world license to develop, manufacture and market cassock.Lexicon will continue to be responsible for all clinical development activities related to type 1 diabetes and maintain aExclusive option of copromoting and having an important function, in collaboration with Sanofi, in the marketing of Sotagliflozine for the treatment of type 1 diabetes in the United States.
Sanofi will be responsible for all clinical development and marketing activities of Sotagliflozine for the treatment of type 2 diabetes worldwide and will be solely responsible for the marketing of Sotagliflozine for the treatment of type 1 diabetes outside the United States.
Lexicon will participate in the financing of a part of the costs planned for the development of the drug to treat type 2 diabetes in the next three years, up to a maximum value of 100 million dollars.