Lexicon Pharmaceuticals announced that it has exercised its option under its collaboration and license agreement with Sanofi to co-promote sotagliflozin, an investigational oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), for the treatment of type 1 diabetes in the US. The opt-in decision was based on positive data from three phase 3 studies, inTandem1, inTandem2, and inTandem3 and is aligned to a planned regulatory filing in the US.
“This marks another milestone for this collaboration and is a meaningful step forward on the path to bringing a novel and first-in-class therapy to patients with type 1 diabetes. This decision allows us to play a significant role in the commercialization of sotagliflozin, if the medicine is approved by the FDA,” said Jeffrey L. Wade, JD, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer. “As we near completion of the type 1 diabetes development program for sotagliflozin, we look forward to additional sotagliflozin clinical data this quarter and presentations at the upcoming EASD meeting in September.”
“Sotagliflozin is an important and innovative investigational medicine for the treatment of type 1 diabetes,” said Stefan Oelrich, senior vice president and head, global diabetes franchise, Sanofi. “People with this disease have few treatment options, and their unmet need for oral medications that can be used with insulin is high. We are pleased with Lexicon’s election to exercise its option to co-promote this product in the US, if approved.”
Sanofi intends to file applications in the first half of 2018 for the EU and US regulatory reviews of sotagliflozin for the treatment of type 1 diabetes, pending the full read out of phase 3 data.
In November 2015, Lexicon and Sanofi entered into a collaboration and license agreement for the development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon received 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 on net sales of sotagliflozin.
Under the collaboration, Lexicon granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes. Sanofi is responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of sotagliflozin for the treatment of 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 an aggregate of $100 million.