Sanofi’s Toujeo Proves Effective in Children and Adolescence for Type 1 Diabetes
Paris-based Sanofi presented data from the EDITION JUNIOR Phase III trial at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference held in Boston. The trial compared Toujeo (insulin glargine 300 Units/mL) compared to insulin glargine 100 Units/mL (Gla-100) in children and adolescents aged 6 to 17 years with type 1 diabetes.
The results of the trial showed that Toujeo had a comparable decrease in average blood sugar (HbA1C) and a similar risk of low blood sugar events. It was the first randomized, controlled trial comparing Toujeo to Gla-100 in this patient population. The primary endpoint was comparable reductions in average blood sugar over six months with both treatments and similar risk of hypoglycemia. The trial hit the primary endpoint. The proportion of patients who had severe hypoglycemia and high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo.
“We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people,” said Thomas Danne, director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children’s Hospital on the Bult, Hannover Medical School, Germany. “In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo.”
In addition, based on the results, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended Taujeo be approved for the expanded indication in Europe.
“Across the globe, between 50 and 80% of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%,” said Dietmar Berger, global head of Development at Sanofi. “By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.”
Also today, Sanofi agreed to pay a $315 million settlement to Genzyme shareholders. Genzyme is a Sanofi subsidiary. The shareholders alleged that Sanofi intentionally slowed the development and launch of Lemtrada (alemtuzumab) for multiple sclerosis (MS) so it would not have to pay the regulatory and sales milestone payments that were due shareholders. Sanofi acquired Genzyme in 2011 for $20 billion, when Lemtrada was still in development.
As part of the original deal, up to $3.8 billion in contingent value rights (CVRs) were part of the original deal terms. CVRs are sometimes used to determine a value for an asset if two parties can’t agree on a specific figure. The shareholders argued that Sanofi’s slow-down resulted in the payout being decreased by $708 million. They filed the lawsuit in 2015.
When Sanofi and Genzyme couldn’t agree on the value of Lemtrada, Sanofi agreed to add one Nasdaq-listed CVR linked to Lemtrada for every Genzyme share. Then it promised to take “diligent effort” to take Lemtrada through development and onto the market. The drug was eventually approved in November 2014, which was too late for the CVR deadline. The drug was initially rejected by the U.S. Food and Drug Administration (FDA).
Sanofi was developing its own MS drug, Aubagio (teriflunomide), at the time. The lawsuit in 2015 alleged that Sanofi chose to focus on Aubagio instead of Lemtrada because there was no additional $3.8 billion payout.
Sanofi has ended the case by agreeing to make the $315 million settlement in return for delisting the CVR from the Nasdaq. It has not admitted any wrongdoing.