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Feb 2, 2011

Zealand and Sanofi-Aventis Achieve First Phase III Success for Lixisenatide Monotherapy

Zealand and Sanofi-Aventis Achieve First Phase III Success for Lixisenatide Monotherapy

Type 2 diabetes drug as good as exenatide at reducing HbA1c, and further reduced hypoglycaemic events. [evgenyb - Fotolia.com]

  • Danish firm Zealand Pharma and its lixisenatide licensee, sanofi-aventis, reported positive topline data from a Phase III trial comparing the type 2 diabetes candidate with exenatide (Byetta®). Data from the GetGoal-X study showed that the GLP-1 receptor agonist lixisenatide achieved its primary endpoint of noninferiority to exenatide in terms of HbA1c reduction from baseline. The initial trial data also showed that threefold fewer type 2 diabetes patients treated using once-daily lixisenatide reported symptomatic hypoglycemic events than those receiving twice-daily exenatide. Six times fewer hypoglycemia events were observed in the lixisenatide group overall.

    The 24-week GetGoal-X study enrolled 639 people, and was the first study directly comparing lixisenatide with exenatide in the reduction of HbA1c levels. The study is one of nine in the GetGoal Phase III program for lixisenatide, which has enrolled over 4,300 people with diabetes, sanofi-aventis points out. The overall program is evaluating lixisenatide in comparison with a range of other oral anti-diabetic agents or insulin. Enrollment of the eight other GetGoal Phase III studies was completed at the end of 2009, and the next results from the program are expected to be released in the second quarter of 2011.

    Commenting on the latest trial data, investment bank SEB Enskilda points out that there is currently only one once-daily GLP-1 analogue on the market—Novo Nordisk’s Victoza® (liraglutide). Moreover, because Roche has now canned its GLP-1 program with taspoglutide, “It seems that lixisenatide will be the second GLP-1 analogue on the market and we think there will definitely be room for another one,” the firm points out.

    Investment banking firm Jeffries International, meanwhile, states lixisenatide has blockbuster potential. It estimates worldwide sales of once-daily GLP-1 agonists could reach $2.5 billion by 2018, with once-weekly formulations further catapulting the market to $4.5 billion. The firm suggests sanofi-aventis’ "marketing muscle" in the diabetes arena could lead to peak worldwide lixisenatide sales of $650 million. It also remains confident that the drug will be launched in ex-U.S. markets by the fourth quarter of 2012, and in the U.S. in the second half of 2013.

    Sanofi-aventis acquired its global license to lixisenatide from Zealand back in 2003, and the firms are developing the drug both as monotherapy for type 2 diabetes, and also for use in combination with sanofi-aventis’ long-acting insulin analogue Lantus® (insulin glargine). Zealand says a complete Phase III development program for the combination therapy is being finalized. Benefits of adding lixisenatide to basal insulin therapy for type 2 diabetes have already been hinted at, however. In September 2010, the partners reported top-line results from the Phase III GetGoal-L-ASIA trial, which showed that adding lixisenatide to existing basal insulin treatment resulted in significantly reduced HbA1c levels, compared with basal insulin plus placebo. This 24-week trial included 311 Asian patients with type 2 diabetes, 60% of whom were actually taking Lantus as their basal insulin.   

    “The lixisenatide combination with sanofi's top-selling product Lantus (basal insulin) is likely to be the primary value driver for Zealand and represent a paradigm shift in Type II diabetes treatment,” the Jeffries’ analysis comments. The firm estimates launch of the combination therapy during the second half of 2014, and projects peak sales of $1.3 billion.

    Novo Nordisk, which markets the currently marketed GLP-1 agonist, Victoza, today also coincidentally released its financial data for last year. The firm said sales of Victoza reached DKK 2,317 million (about $424 million) in 2010. The drug was approved both in the U.S. and in Japan during January 2010. Clearance in Europe was achieved in July 2009.


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