Earnings Release • Jun 24, 2011
Preview not available for this file type.
Download Source File-- Once-daily Lyxumia® demonstrates non-inferior reduction of blood glucose and
good safety with less hypoglycemia versus exenatide twice daily in Type 2
diabetes patients
-- Once-daily Lyxumia® in combination with basal insulin improves glycemic
control in Asian Type 2 diabetes patients
-- Four abstracts presented, including the full data from the Phase III
GetGoal-X and GetGoal-L Asia studies
Copenhagen, 24 June 2011 - Zealand Pharma A/S (NASDAQ OMX: ZEAL), a
biopharmaceutical company based in Denmark, announces that its partner Sanofi
has published additional positive data from four studies with Lyxumia®
(lixisenatide), a once-daily GLP-1 analogue, which is completing Phase III
clinical development for the treatment of Type 2 diabetes. Lixisenatide was
discovered by Zealand Pharma and global rights are licensed to Sanofi.
The data is being presented at the American Diabetes Association (ADA)'s 71st
Scientific Sessions in San Diego, California and include the full results from
GetGoal-X and GetGoal-L Asia, two clinical Phase III GetGoal-studies with
Lyxumia® in Type 2 diabetes patients that are not adequately treated with oral
therapies or with basal insulin alone. Top-line results from the two studies
were announced in September 2010 and February 2011, respectively.
Commenting on this announcement, David Solomon, President and Chief Executive
Officer of Zealand Pharma, said: “We are pleased that our partner Sanofi is
successfully advancing Lyxumia® towards completion of Phase III and now is
presenting these additional four sets of positive study findings at the 2011
ADA meeting. The data provides further confirmatory signs of the attractive
potential of Lyxumia® as an effective and safe treatment of Type 2 diabetes. We
are delighted that the program is progressing so well.”
“Lixisenatide once-daily demonstrated efficacy in blood glucose control and by
meeting an endpoint of non-inferiority at week 24 in a head-to-head study
versus exenatide twice daily,” said Julio Rosenstock, MD, director of the
Dallas Diabetes and Endocrine Center at Medical City Dallas and lead
investigator of the GetGoal-X trial;
Summaries of the four abstracts presented are highlighted below.
In the clinical Phase III GetGoal-X study, lixisenatide once daily achieved its
primary endpoint of non-inferiority in HbA1c reduction from baseline with less
symptomatic hypoglycemia (low blood sugar) and better gastrointestinal
tolerability versus exenatide twice daily, as an add-on to metformin in
patients with Type 2 diabetes.
GetGoal-X, a randomized, open-label, active-controlled, two-arm parallel-group,
multicenter study, included a total of 634 patients who were randomized to
receive 24-week treatment with either lixisenatide or exenatide. Both groups
received a stepwise increase in dose, up to a maximum daily dose of 20µg. At
baseline, the mean age in the trial was 57.4 years, mean diabetes duration 6.8
years, mean body mass index (BMI) 33.6 kg/m2 and mean HbA1c 8.0 percent.
Data from the Phase III GetGoal-L Asia study showed that lixisenatide
once-daily significantly improved glycemic control versus placebo at week 24 in
combination with basal insulin. Lixisenatide also demonstrated a pronounced
post-prandial glucose and fasting plasma glucose effect, and was well
tolerated. The study included 311 Asian patients with Type 2 diabetes
insufficiently controlled by basal insulin ± sulfonylurea.
In this pre-clinical study, data showed that lixisenatide once-daily protects
against myocardial ischemia-reperfusion injury (tissue damage caused by
restriction of oxygen-rich blood to the heart) in isolated rat hearts by
significantly reducing myocardial infarct size (measurement of damage to the
heart).
Data from several preclinical studies showed that treatment with lixisenatide
was more effective in delaying gastric emptying and lowering prandial glucose
excursions (change in glucose concentration after a meal) than liraglutide.
The agreement with Sanofi and financial outlook
Under the licence agreement between Sanofi and Zealand Pharma, Sanofi is
developing lixisenatide both as monotherapy in the Phase III GetGoal program
and in a combination with Lantus®, its best selling global insulin product.
Zealand Pharma is eligible to receive remaining milestone payments of up to EUR
235 million and double-digit royalties on worldwide sales of both lixisenatide
as monotherapy and of combination products that include lixisenatide.
The data to be presented for Lyxumia® at ADA does not change Zealand Pharma's
expectations in 2011 to receive a total of DKK 150 (€20) million of revenues
and other income under the Boehringer Ingelheim agreement, nor the company's
guidance on total operating expenses of DKK 170 (€23) million for the full
year.
For further information, please contact:
Zealand Pharma A/S
David Solomon, President and Chief Executive Officer
Tel: +45 4328 1200
Hanne Leth Hillman, Vice President for IR & Corporate Communications
Mobile: +45 5060 3689
About Lyxumia® (lixisenatide)
Lyxumia® (lixisenatide), a once-daily GLP-1 receptor agonist, is completing
Phase III development for the treatment of patients with Type 2 diabetes.
Lixisenatide was in-licensed from Zealand Pharma A/Sby Sanofi (EURONEXT: SAN
and NYSE: SNY). Lyxumia® is the intended trademark for lixisenatide.
Lixisenatide is not currently approved or licensed anywhere in the world.
About GLP-1 receptor agonists
GLP-1 (glucagon-like peptide-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 to stimulate insulin secretion by
pancreatic beta cells. GLP-1 receptor agonists are members of an established
class of diabetes drugs approved by regulatory authorities and marketed
globally as an add-on treatment for patients with Type 2 diabetes. Their use is
endorsed by the European Association for the Study of Diabetes, the American
Diabetes Association, the American Association of Clinical Endocrinologists and
the American College of Endocrinology. Several novel GLP-1 receptor agonists
are in development.
About the GetGoal Phase III clinical program
The GetGoal Phase III clinical program will provide data for the efficacy and
safety of lixisenatide in adults with Type 2 diabetes treated with various oral
anti-diabetic agents or insulin. With nine trials in the program, GetGoal
started in May 2008 and has enrolled more than 4300 patients. To date
GetGoal-X, GetGoal-Mono, GetGoal-L Asia, GetGoal-S and GetGoal-L have reported
and all with positive top-line results, offering clinical support for the
efficacy and safety profile of lixisenatide. Further results from the GetGoal
Phase III program are expected during 2011.
About Zealand Pharma
Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company
based in Copenhagen, Denmark with a mature and growing clinical pipeline of
innovative peptide based drugs. The company's lead product is Lyxumia®
(lixisenatide), a once-daily GLP-1 agonist licensed to Sanofi, who is
responsible for the late-stage Phase III development of Lyxumia® for the
treatment of Type-2 diabetes. 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 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 with favorable therapeutic attributes, 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
more information please visit www.zealandpharma.com
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.