Sanofi Stuck Between a Rock and a Hard Place With Lantus Heir Toujeo
April 13, 2015
By Riley McDermid and Krystle Vermes, BioSpace.com Breaking News Staff
French biopharmaceutical company Sanofi is coming under fire Monday, after saying it is unlikely to discount its new insulin treatment, Toujeo, as a way to tempt payers, even though a recent study has shown it is more effective than its current insulin blockbuster Lantus.
“There is no reason to give higher rebates,” Pierre Chancel, head of Sanofi’s diabetes business, told Bloomberg. “Toujeo is an improvement on something that is already great. We don’t necessarily need to compare it to Lantus.”
That’s being seen by market watchers as an attempt by Sanofi to have its cake and eat it, too--particularly since Lantus raked in $6.72 billion in sales in 2014 and lost its patent protection at precisely the same time Toujeo won approval from American regulators.
“This is a no-win game,” Fabian Wenner, an analyst at Kepler Cheuvreux in Zurich, told Bloomberg. “Everything that Toujeo will garner will be cannibalizing Lantus.”
Sanford Bernstein analyst Tim Anderson agreed, comparing the new dilemma to a similar situation GlaxoSmithKline had when it began to phase out its allergy medicine Advair for faster working Breo.
“Part of Breo’s problem was that Glaxo essentially priced it at parity to Advair, meaning it gave no real incentive for U.S. payers to support the product,” said Anderson. “It has worried us that Sanofi might do the same with Toujeo.”
Sanofi announced on Feb. 25 that the U.S. Food and Drug Administration (FDA) had granted approval of Toujeo, a 300 U/mL insulin glargine injection, for the treatment of adults living with type 1 and type 2 diabetes.
The approval is based on data from the EDITION clinical trial program, which looked at more than 3,500 adults living with type 1 and type 2 diabetes. EDITION is a series of international Phase III studies designed to evaluate the efficacy and safety of the drug in diabetes patients. After analyzing the data, the FDA found that the program had met its primary study endpoints by demonstrating blood sugar control.
"Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade,” said Pierre Chancel, senior vice president of Global Diabetes at Sanofi. “With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes.”
Toujeo is available in the form of a disposable pen. It is currently pending market authorization with the European Medicines Agency.
"Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and healthcare professionals due to hypoglycemia concerns,” saidJohn Anderson, internal medicine and diabetes specialist at the Frist Clinic. “Toujeo provides a new option that may help patients manage their diabetes."
Toujeo Trumps Lantus in EDITION
In June 2014, Sanofi initially announced that Toujeo had shown that it could reduce low blood sugar rates more than Lantus, a similar product marketed by the company. In an eight-week titration period, Toujeo showed more significant reductions, which brought encouragement to researchers on the EDITION project.
"Toujeo has been recently accepted for review by EMA and this important milestone is another step forward in expanding our insulin portfolio," Chancel said at the time of the announcement. "We continue to be encouraged by the positive Phase III results from EDITION, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes."
Lantus is a once-daily injectable that provides diabetics with blood sugar control for 24 hours. It is designed for patients to use in conjunction with an existing diabetes management plan.