The results were presented in an oral presentation today at 10:45am local time (7:45am CET) at the 21st World Diabetes Congress in Dubai, United Arab Emirates, under the following headline: "Efficacy and safety of lixisenatide QD 2) morning and evening injections versus placebo in T2DM inadequately controlled on metformin (GetGoal-M)".
GetGoal-M is the seventh study under the global GetGoal Phase III program, and the eighth consecutive Phase III study including the GetGoal Duo 1 study, to report positive results that support the efficacy and safety of lixisenatide as a potential new treatment option for patients with Type 2 diabetes.
Commenting on today's announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "Eight consecutively positive Phase III studies have now been reported for lixisenatide providing a substantial body of clinical evidence for the potential of lixisenatide as a new treatment option for patients with Type 2 diabetes and their caregivers. Lixisenatide has been filed for registration in Europe and regulatory submission in the United States is expected in Q4 2012."
GetGoal-M is a multicenter, randomized, 4-arm, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of lixisenatide (Lyxumia(R)) as morning or evening injections in 680 patients with Type 2 diabetes insufficiently controlled with metformin alone.
Results from the study show that both morning and evening dosing of lixisenatide met the primary endpoint of significant HbA1c reduction over 24 weeks versus placebo (p<0.0001). For both dosing groups fasting plasma glucose was significantly reduced versus placebo (p<0.005). Lixisenatide also significantly increased the proportion of patients achieving HbA1c of less than 7.0% (43% for morning dosing, 41% for evening dosing, 22% for placebo). Body weight was reduced in all groups (-2.0 kg for lixisenatide morning and evening dosing, -1.6kg for placebo).
1) Lyxumia(R) is the intended trademark for lixisenatide
2) QD = once a day
The percentage of patients requiring rescue therapy for hyperglycemia (high blood sugar) was significantly lower in the lixisenatide morning and evening groups than in the placebo group. Consistent with the GLP-1 class, the most common adverse events were nausea and vomiting. There was a low incidence of hypoglycemia (low blood sugar): 2.4% for morning lixisenatide, 5.1% for evening lixisenatide versus 0.6% for placebo, with no severe episodes.
In November 2011, the European Medicines Agency (EMA) accepted Sanofi's marketing authorization application filed for lixisenatide (Lyxumia(R)). Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012.
The agreement with Sanofi and financial outlook
Under the license agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide both as a stand-alone product (intended trademark Lyxumia(R)) in the Phase III GetGoal program and in a combination pen device with Sanofi's basal insulin Lantus(R). Zealand Pharma is eligible to receive remaining milestone payments of up to USD 235 million and low double-digit royalties on global net sales of lixisenatide and any combination product that includes lixisenatide.
The results of GetGoal-M do not change Zealand Pharma's financial guidance for 2011 of DKK 170 (EUR 22.8) million in revenues and other income and total operating expenses of DKK 170 (EUR 22.8) million.
For further information, please contact:
David H. Solomon, President & CEO, Tel: +45 2220 6300
Hanne Leth Hillman, Vice President for IR & Corporate Communication,
Tel: +45 5060 3689, email: hlh@zealandpharma.com
About lixisenatide (Lyxumia(R))
Lixisenatide, a glucagon-like peptide-1 (GLP-1) agonist for once-daily dosing, is in development for the treatment of patients with Type 2 diabetes mellitus. Lixisenatide was discovered by Zealand Pharma and has been licensed to Sanofi. Lyxumia(R) is the intended trademark of lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.
GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for Type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists and the American College of Endocrinology.
The GetGoal Phase III clinical program provides data for lixisenatide in adults with Type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program started in May 2008 and has enrolled more than 4,500 patients. To date, top-line results have been reported from the GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S, GetGoal-F1 and GetGoal-M studies, all supporting potential efficacy and safety for lixisenatide. Further, positive top-line results have been reported from the Phase III GetGoal Duo 1 study (also known as EFC10781*) supporting in particular the efficacy and safety of lixisenatide for use in combination with Lantus(R) (insulin glargine). Further Phase III results are expected in 2012.
* NCT00975286 on www.clinicaltrials.gov
About Zealand Pharma
Zealand Pharma A/S is a public (Copenhagen:ZEAL.CO - News) biopharmaceutical company based in Copenhagen, Denmark with a mature and growing clinical pipeline of innovative peptide based drugs. The company's lead product is lixisenatide (Lyxumia(R) 1)), a once-daily GLP-1 agonist for the treatment of Type 2 diabetes, discovered by Zealand Pharma and licensed to Sanofi. In November, Sanofi filed for marketing authorization for lixisenatide (Lyxumia(R)) in Europe. Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the treatment of chemotherapy- and radiotherapy- induced diarrhea.
Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs, and all drug candidates in its pipeline have been identified through the company's own drug discovery activities. Zealand Pharma's products target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com.
Note 1) Lyxumia(R) is the intended trademark for lixisenatide
