Positive Top-Line Phase III Data in Type 2 Diabetes Achieved for lixisenatide Once-Daily vs. Exenatide Twice-DailyBy Zealand Pharma As, PRNE
Tuesday, February 1, 2011
Lixisenatide Meets Primary Efficacy Endpoint With Fewer Hypoglycaemias
COPENHAGEN, Denmark, February 2, 2011 - Zealand Pharma A/S (NASDAQ OMX: ZEAL), a biopharmaceutical
company dedicated to the discovery and development of innovative peptide
drugs, is pleased to announce that its partner, sanofi-aventis, today
announced that the GetGoal-X Phase III study of lixisenatide, a once-daily
GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary
endpoint of non-inferiority in HbA1c reduction from baseline, compared with
In addition, the initial results showed that significantly
fewer people with type 2 diabetes treated with lixisenatide once-daily
reported hypoglycemic events versus patients treated with exenatide. In the
lixisenatide arm three-fold fewer people reported symptomatic hypoglycemia
than people who were on exenatide (2.5% vs. 7.9%; p<0.05). Six-fold fewer
hypoglycemia events were observed in patients on lixisenatide than those
treated with exenatide (8 vs. 48 events). Other endpoints were broadly
consistent with what has been observed with other GLP-1 agonists.
Commenting on today's announcement, David Solomon, President
and Chief Executive Officer of Zealand Pharma, said: "We are delighted that
lixisenatide achieved its primary endpoint in this first Phase III
head-to-head study with a marketed GLP-1 product. This is a further
confirmatory step in the development and approval path for lixisenatide,
lending additional support to the drug's potential role for patients with
type 2 diabetes and their care providers."
The GetGoal-X clinical trial is a randomized, open-label,
active-controlled, two-arm parallel-group, multicenter study, with a 24-week
main treatment period. It compared the efficacy and safety of the two GLP-1
receptor agonists: once-daily lixisenatide vs. twice-daily exenatide as
add-on therapy for people with type 2 diabetes whose condition is
inadequately controlled by metformin. A total of 639 people were randomized
to receive either lixisenatide or exenatide. Both groups received a stepwise
increase in dose, up to a maximum daily dose of 20microg.
"GetGoal-X, the first head-to-head study comparing
lixisenatide with another GLP-1, demonstrates the efficacy of lixisenatide
once-daily in reducing HbA1c in people with type 2 diabetes and also shows a
better hypoglycemia profile," said Pierre Chancel, Senior Vice President,
Global Diabetes, sanofi-aventis, "The lixisenatide clinical development
program exemplifies our commitment to people with diabetes and our ambition
to help them manage their condition more effectively."
The full study findings will be presented by sanofi-aventis at
a medical congress.
About Zealand Pharma A/S
Zealand Pharma is a Danish biopharmaceutical company dedicated
to the discovery and development of innovative peptide drugs. The Company is
based in Copenhagen and joined the NASDAQ OMX Copenhagen in November 2010
trading under the ticker symbol 'ZEAL'.
Zealand Pharma targets diseases where it believes existing
treatments fail to adequately serve the medical needs of patients and the
market potential for improved treatments through the use of peptide drugs is
Zealand Pharma focuses on three therapeutic areas: metabolic
(diabetes and obesity), gastrointestinal and cardiovascular diseases. The
Company's expertise in peptide discovery, optimization and development has
resulted in a strong and growing pipeline of novel peptide drug candidates
with favourable therapeutic attributes.
Since 1999, Zealand Pharma's scientists have built a pipeline
that includes five compounds in clinical development, four of which have been
out licensed, two of these with major pharmaceutical companies
(sanofi-aventis and Helsinn Healthcare). All of Zealand Pharma's compounds
emerged from the Company's own drug discovery.
For more information please visit the Company's web site:
Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in
development for the treatment of patients with type 2 diabetes mellitus.
The efficacy and safety of lixisenatide once-daily is being
assessed in the GetGoal Phase III clinical trial program. The GetGoal
clinical trial program started in May 2008 and has enrolled more than 4,500
patients globally. Enrolment of the GetGoal Phase III program assessing
efficacy and safety of lixisenatide in adult patients with type 2 diabetes
mellitus treated with various oral anti-diabetic agents or insulin was
completed at the end of 2009. The next results of the GetGoal Phase III
program are expected to be released in Q2 2011.
About GLP-1 receptor agonists
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 EASD, the American Diabetes
Association, the American Association of Clinical Endocrinologists and the
American College of Endocrinology.
About diabetes and type 2 diabetes (Source: WHO)
- More than 220 Million people worldwide have diabetes - In 2005, an estimated 1.1 Million people died from diabetes - Almost 80% of diabetes deaths occur in low- and middle-income countries - Almost half of diabetes deaths occur in people under the age of 70 years; 55% of diabetes deaths are in women - WHO projects that diabetes deaths will double between 2005 and 2030 - Healthy diet, regular physical activity, maintaining a normal body weight and avoiding tobacco use can prevent or delay the onset of diabetes
Type 2 diabetes results from the body's ineffective use of insulin. Type
2 diabetes comprises 90% of people with diabetes around the world, and is
largely the result of excess body weight and physical inactivity. Symptoms
may be similar to those of type 1 diabetes, but are often less marked. As a
result, the disease may be diagnosed several years after onset, once
complications have already arisen. Until recently, this type of diabetes was
seen only in adults but it is now also occurring in children.
For further information, please contact:
Zealand Pharma A/S
David Solomon, President and Chief Executive Officer,
Mary-Jane Elliott / Emma Thompson / Amber Bielecka / Ulf
Martensson, Tel: +44-20-7920-2330 / +46-8-407-22-43
For further information, please contact: Zealand Pharma A/S, David Solomon, President and Chief Executive Officer, Tel: +45-4328-1200, M:Communications. Mary-Jane Elliott / Emma Thompson / Amber Bielecka / Ulf, Martensson, Tel: +44-20-7920-2330 / +46-8-407-22-43
Tags: Copenhagen, denmark, February 2, Zealand Pharma A/s