LONDON, UK (GlobalData), 19 June 2012 - During the 72nd American Diabetes Association Scientific Sessions, which occurred June 8th–12th in Philadelphia, data from several key Phase III clinical trials was presented by Big Pharma.
One of the notable presenters was Sanofi, who presented promising Phase III data based on their GetGoal Duo1 and GetGoal L studies, that looked at a combination therapy of Lantus (insulin glargine) and Lyxumia (lixisenatide) with or without oral metformin in patients who are new to or already using insulin, or who could not control their diabetes with basal insulin, respectively. The studies found that the combination therapy reached its clinical endpoint by lowering HbA1c levels, resulting in lower postprandial glucose.
Lantus is Sanofi’s class-leading insulin glargine therapy, which generates revenues estimated at $4.5 billion per year and is set to go off patent in mid-2015. Lyxumia is a GLP-1 receptor agonist that is not yet approved for marketing in the US. Sanofi has filed for approval in Europe, hopes to file for an NDA in the US by the end of 2012, and recently submitted an application for approval in Japan. Lyxumia will be fourth to market in its class behind Novo’s first-in-class Victoza (liraglutide), and Amylin’s Byetta (exenatide) and Bydureon (exenatide).
The move appears to be an attempt by Sanofi to use its current portfolio and pipeline to protect against its steep patent cliff over the next few years. A combination therapy between Lantus and Lyxumia would potentially have two positive effects for Sanofi: help extend the life of the blockbuster drug Lantus; and act as a promotional tool for Lyxumia. Because Lyxumia is fourth to market and does not have any substantial differentiating attributes, it is unlikely to have significant market penetration, and certainly will not pose a threat to Novo’s Victoza. Therefore, Sanofi has an opportunity to market Lyxumia as an adjunctive therapy to Lantus, which should help with market penetration and increase sales in the United States and abroad where Lantus has a strong hold.
In addition to Sanofi’s announcement, partners AstraZeneca (AZ) and Bristol-Myers Squibb (BMS) also announced Phase III data from a trial evaluating their sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin along with Januvia (sitagliptin) The results showed significantly lowered HbA1c levels compared to sitagliptin alone. Januvia is an orally administered dipeptidyl peptidase-4 (DPP-4) inhibitor marketed by Merck & Co., and is set to control over half the DPP-4 inhibitor market, with annual sales expected to reach over $4.5 billion by 2013. Therefore, a best-in-class add-on to Januvia could generate significant revenues – particularly if it is marketed in conjunction with DPP-4 therapies. BMS and AZ previously filed an NDA for dapagliflozin, but were issued a complete response letter to reexamine the risk-benefit profile.
Also presenting Phase III data at the scientific sessions was Janssen Research & Development with their drug canagliflozin, a direct competitor to AZ and BMS’ dapagliflozin. Canagliflozin is also an SGLT2 inhibitor, intended for use alone or in combination with sitagliptin or glimepiride (Amaryl, marketed as a glucose reduction agent by Sanofi). Janssen Research and Development, with its US marketing partner Mitsubishi Tanabe Pharma, filed for an NDA in May 2012.
Clearly the product that is able to reach the market first has the distinct advantage in the SGLT2 inhibitor space. However, canagliflozin may have an advantage over dapagliflozin regardless of its arrival on the market because it is being investigated as an add-on therapy as well as a stand-alone product. This would mean sales outside of the diabetic population taking DPP-4 inhibitors, whereas dapagliflozin will be limited to this subset.