As the diabetes market heats up, Sanofi appears poised to take the lead. Just this past month, the FDA began the review of the company's type 2 diabetes treatment Lyxumia (which was recently approved in the EU), while competitor Novo Nordisk received another setback for blockbuster hopeful (and would-be Lantus rival) Tresiba. As Sanofi has expanded to more treatments in diabetes, Novo has struggled to keep pace.
Tresiba, or insulin degludec, was turned away by FDA last week with a request for additional clinical trials to clarify cardiovascular risks that worried a FDA advisory committee in November. This leaves Sanofi's $7 billion insulin franchise Lantus to clean up, as analysts continue to hike their recommendations. Jeffries & Company analysts increased their forecasts for 2013 and beyond by 1-9% while Leerink Swann's Seamus Fermandez upped his forecast for Lantus to $8.83 billion for 2020 (nearly a billion higher than previous estimates), even before news of Tresiba's letdown hit the airwaves.
But it's not all bad news for Tresiba. The drug's UK price is currently set 60-70% higher than Lantus—a silver lining for the Danish manufacturer, which expects that market valuation to be adopted by the rest of the EU. That price premium may indicate that European leaders see a clear competitive advantage for Tresiba—an advantage not obscured by its cardiovascular risks.
This morning, Novo Nordisk released the findings of a randomized clinical trial pitting its long-acting insulin, Levemir, against Lantus. The findings favor Lantus, which hit targets more consistently than Levemir on HbA1c blood glucose tests during the 26-week trial—but the findings also demonstrated that patients who received Lantus gained weight and had an increase in BMI, while Levemir recipients showed weight loss.
The study's timing may suggest that Novo is banking on Levemir to become a more prominent choice for doctors and patients, given Tresiba's delay in reaching U.S. pharmacies.
Sanofi's advance in the type 2 diabetes market comes in the form of Lyxumia (lixisenatide), a GLP-1 receptor agonist which is taken with oral glucose-lowering treatments. Lixisenatide differs from the competition in that it requires a once-a-day injection rather than two. Sanofi argues that Lyxumia is a safer alternative to Bristol-Myers Squibb GLP-1 treatment, Byetta. Regardless, Sanofi will face stiff competition from GLP-1's like Victoza and Bydureon, which remain standout leaders in the category.
Sanofi also has plans for a combination injector pen, pairing Lantus with Lyxumia in a move that could heighten market reliance on Lantus, as well as increase exposure for newcomer Lyxumia.
An earlier version of this story incorrectly reported that Novo Nordisk's Levemir hit targets more consistently on HbA1c tests. Sanofi's Lantus showed more consistency in hitting those blood glucose test targets.