Sanofi SA (ADR) (NYSE:SNY) announced encouraging data from a phase III study (EDITION II, n = 811) evaluating its new insulin candidate, U300. Sanofi expects to submit regulatory applications in the U.S. and Europe for the candidate in the first half of 2014.
The EDITION II study assessed the safety and efficacy of U300 versus Lantus in patients with type II diabetes already under basal and oral antidiabetic medications. Data from the study revealed that U300 was similar in efficacy to Lantus in terms of blood sugar reduction. However, 23% fewer patients experienced night-time low blood sugar events with U300 as compared to Lantus.
Sanofi SA (ADR) (NYSE:SNY) also announced positive top-line data from EDITION III, EDITION IV and EDITION JP I studies. The EDITION III (n =878) study compared U300 with Lantus in type II diabetes patients, who have not received insulin therapy. Moreover, their disease was not controlled by oral medications. Meanwhile, EDITION IV (n = 549) and JP1 (conducted on Japanese patients, n = 243) studies compared U300 with Lantus in type I diabetes patients on basal and mealtime insulin. The three studies met the primary endpoint. Full results from these studies will be presented in the first half of 2014.
Lantus, which generated sales of €4.2 billion in the first nine months of 2013, is one of the top-selling drugs at Sanofi SA (ADR) (NYSE:SNY). U300 on approval is expected to further strengthen Sanofi’s product portfolio. Although Sanofi SA (ADR) (NYSE:SNY) holds a strong position in the diabetes market, we note that the market is highly crowded with players like Novo Nordisk A/S (NYSE:NVO) and Eli Lilly & Co. (NYSE:LLY).
Sanofi SA (ADR) (NYSE:SNY), a large cap pharma company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the large cap pharma space include Johnson & Johnson (NYSE:JNJ), which carries a Zacks Rank #2 (Buy).
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