Sanofi and Lexicon Pharmaceuticals, Inc., a biopharmaceutical company, have entered into a collaboration and license agreement for the development and commercialization of sotagliflozin, an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for people with diabetes.

Under the agreement, Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory, and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties of net sales of sotagliflozin. Sanofi obtains an exclusive worldwide license to develop, manufacture, and commercialize sotagliflozin. Lexicon will continue to be responsible for all clinical development activities relating to Type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of Type 1 diabetes in the United States. Sanofi will be responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of Type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of Type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned Type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.

The developmental medicine sotagliflozin is currently being studied in two Phase III trials in Type 1 diabetes, which are expected to report top-line results during the second half of 2016. Phase III trials in Type 2 diabetes are expected to begin in 2016.

The agreement is subject to customary filing and review under the Hart-Scott-Rodino Antitrust Improvements Act.

Source: Sanofi