Sanofi licensed global rights to Lexicon Pharmaceuticals' experimental diabetes therapy sotagliflozin under a deal potentially worth up to $1.7 billion, the companies reported Friday. Under the agreement, Sanofi will make an upfront payment of $300 million to Lexicon, with the latter eligible to receive milestone payments of up to $1.4 billion, in addition to tiered, escalating double-digit percentage royalties on net sales.
In the agreement, in which Sanofi will be granted exclusive worldwide rights to develop, manufacture and commercialise sotagliflozin, Lexicon will hold responsibility for all clinical development activities related to type 1 diabetes. The drugmaker will hold an option to co-promote and have a significant role in the commercialisation of sotagliflozin for the treatment of type 1 diabetes in the US.
Meanwhile, Sanofi will be responsible for all clinical development and commercialisation activities related to sotagliflozin for the treatment of type 2 diabetes, while the French drugmaker will have sole responsibility for the development of the drug for the treatment of type 1 diabetes outside the US. Lexicon will be partly responsible for funding the costs of development activities related to the type 1 diabetes indication over the next three years, up to a maximum of $100 million.
Sotagliflozin, which inhibits SGLT-1 and SGLT-2, is currently being studied in two pivotal Phase III trials in type 1 diabetes, which are expected to report top-line results during the second half of 2016. Meanwhile, late-stage studies in type 2 diabetes are planned to begin next year.
Sanofi executive vice president Pascale Witz commented "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." Earlier this week, Sanofi reached an agreement to license exclusive global rights to Hamni Pharmaceuticals' experimental GLP-1-RA agonist efpeglenatide in a deal valued at as much as 3.9 billion euros ($4.2 billion).
Separately, on Friday, Sanofi indicated that it does not anticipate earnings growth in 2016 or 2017 due to several variables including "headwinds in diabetes." Earlier this month, the drugmaker said that it expects diabetes sales to decline an average annualised rate of between 4 percent and 8 percent on a constant currency basis through 2018.
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