Memorandum
This morning, Sanofi announced that the phase 3 LixiLan-O trial met its primary endpoint, demonstrating statistically superior A1c reductions with the highly-awaited LixiLan (lixisenatide/insulin glargine) vs. Lyxumia (lixisenatide) or Lantus (insulin glargine) alone after 30 weeks. The randomized, open-label trial enrolled 1,170 patients with type 2 diabetes on metformin with or without a second oral agent. The press release did not include any further details on the primary results or any secondary endpoints (which included postprandial excursions, body weight, seven-point glucose profiles [cool to see this measure of glycemic variability], fasting plasma glucose, percentage of patients reaching A1c targets, and daily dose of insulin glargine). In terms of safety, the press release stated only that LixiLan demonstrated a safety profile reflecting those of its components, but we would hope that the combination might have led to improvements in hypoglycemia (and weight) vs. Lantus and GI side effects vs. Lyxumia. Sanofi plans to present full results “in an appropriate scientific forum” (we assume it is too late for EASD) and we hope to hear additional details during the company’s 2Q15 update Thursday, as we have viewed GLP-1 agonist/basal insulin combinations as one of the most exciting new treatment options for type 2 diabetes for a very long time. The other phase 3 study for LixiLan, LixiLan-L (n=736 patients with type 2 diabetes on basal insulin), is expected to complete in 3Q15 (this month according to ClinicalTrials.gov). Sanofi will analyze the results from both studies before determining the next steps. As of now, regulatory submissions are still planned for 4Q15 in the US and 1Q16 in the EU, consistent with guidance in Sanofi’s 1Q15 update. This means LixiLan would likely reach the market around the beginning of 2017, which is roughly the same timeline expected for Novo Nordisk’s Xultophy (insulin degludec/liraglutide) in the US; Xultophy, of course, is already on the market in Europe and tearing it up ...