Five abstracts on Zealand Pharma invented diabetes drug candidates, including Lyxumia® (lixisenatide), licensed to and developed by Sanofi, to be presented at the EASD 48th Annual Meeting
9/26/2012 2:00 AM EST
Zealand Pharma A/S
Press release
Five abstracts on Zealand Pharma invented diabetes drug candidates, including
Lyxumia® (lixisenatide), licensed to and developed by Sanofi, to be presented
at the EASD 48th Annual Meeting
Copenhagen, 2012-09-26 08:00 CEST (GLOBE NEWSWIRE) -- Press Release
No. 6/2012
-- One oral and two poster presentations of clinical data on Lyxumia®1
(lixisenatide), an investigational new once-daily GLP-1 agonist, filed by Sanofi
for registration in Europe and Japan with filing in the US expected in December
2012
-- One oral and one poster presentation of preclinical data on Zealand Pharma’s
proprietary investigational novel GLP-1-gastrin dual agonist, ZP3022
Copenhagen, Denmark – 26 September 2012 – Zealand Pharma A/S (NASDAQ OMX
Copenhagen: ZEAL), a Danish biotechnology company dedicated to the discovery
and development of peptide drugs, informs that a series of clinical data will
be presented on lixisenatide (Lyxumia®) at the European Association for the
Study of Diabetes (EASD) 48th Annual Meeting on 1-5 October 2012 in Berlin,
Germany, supporting the potential of this investigational new once-daily GLP-1
agonist as a new treatment for Type 2 diabetes. Lixisenatide was invented by
Zealand Pharma and global rights are licensed to Sanofi (EURONEXT: SAN and
NYSE: SNY), who has filed for registration of the product in Europe and Japan
and expects filing in the US in December 2012.
Further at EASD, Zealand Pharma will present data from preclinical studies of
ZP3022, a proprietary novel compound from the company’s program on dual acting
GLP-1-gastrin peptide agonists.
Highlights of the clinical data to be presented on lixisenatide (Lyxumia®) are
as follows (abstracts have been posted on the EASD website):
“Effects of lixisenatide once daily on gastric emptying and its relationship to
postprandial glycaemia in type 2 diabetes mellitus” [Abs 808-EASD] – POSTER
presentation
When: Wednesday 3 October, 12:00pm – 1:00pm CET
Presenter: M. Lorenz, Sanofi-Aventis Deutschland GmbH
Location: Berlin Fair Exhibition Halls, Poster Hall
“Efficacy and safety of once-daily lixisenatide in type 2 diabetes
insufficiently controlled with basal insulin ± metformin: GetGoal-L2 study”
[Abs 3-EASD] – ORAL presentation
When: Tuesday 2 October, 11:15am – 11:30am CET
Presenter: R. Aronson, LMC Endocrinology Centres, Toronto, Canada
Location: Berlin Fair Exhibition Halls, Langerhans Hall
“Once-daily lixisenatide added on to consistently titrated insulin glargine
plus oral agents in type 2 diabetes: the GetGoal-Duo 13 study” [Abs 807-EASD] –
POSTER presentation
When: Wednesday 3 October, 12:00pm – 1:00pm CET
Presenter: J. Rosenstock, Dallas Diabetes and Endocrine Center at
Medical City, Dallas, U.S.A.
Location: Berlin Fair Exhibition Halls, Poster Hall
Highlights of the preclinical data to be presented on ZP3022 are as follows
(abstracts have been posted on the EASD website):
“The novel GLP-1-Gastrin dual agonist ZP3022 improves glycemic control in ZDF
rats” [Abs 823-EASD] – POSTER Presentation
When: Wednesday 3 October, 1:15pm – 2:15pm CET
Presenter: Jolanta Skarbaliene, M.Sc (Pharm.), Scientist, Ph.D.
Student, Zealand Pharma A/S, Copenhagen, Denmark
Location: Berlin Fair Exhibition Halls, Poster Hall
”The GLP-1-gastrin dual agonist ZP3022 increases beta cell mass via an increase
in mean islet mass in db/db mice” [Abs 177-EASD] – ORAL Presentation
When: Thursday 4 October, 10:15am – 11:45am CET, in session
“Beta cell function in vivo”
Presenter: Dorthe L. C. Almholt, M.Sc, Ph.D, Scientist, Zealand
Pharma A/S, Copenhagen, Denmark.
Location: Berlin Fair Exhibition Halls, Rubner Hall
For further information, please contact:
Zealand Pharma A/S
David H. Solomon, President & CEO, Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President for IR & Corporate Communication,
Tel: +45 50 60 36 89, email:
References
1. Lyxumia is the proprietary name submitted to the EMA for lixisenatide, an
investigational once-daily GLP-1 agonist, invented by Zealand Pharma and
licensed to and developed by Sanofi for the treatment of Type 2 diabetes. The
proprietary name for lixisenatide in the United States is under consideration.
Lixisenatide is not currently approved or licensed anywhere in the world.
2. GetGoal-L (NCT00715624 www.clinicaltrials.gov)
3. GetGoal Duo 1 (also known as EFC 10781) (NCT00975286
www.clinicaltrials.gov)
About lixisenatide (Lyxumia®)
Lixisenatide (Lyxumia®) is a once-daily GLP-1 agonist, invented by Zealand
Pharma. The global rights to lixisenatide are licensed to Sanofi, who is
developing the product for the treatment of Type-2 diabetes, both as a
stand-alone drug and in a combination device with Lantus® (insulin glargine),
Sanofi’s world-leading basal insulin product. The GetGoal Phase III clinical
program, which completed in February 2012, has provided data for lixisenatide
(Lyxumia®) in adults with Type 2 diabetes treated in monotherapy, with various
oral anti-diabetic agents or in combination with basal insulin. The GetGoal
program has enrolled more than 5,000 patients.
Sanofi filed for registration of lixisenatide in Europe in November 2011 and an
opinion from the Committee for Human Medicinal Products under EMA is expected
in Q4 2012. Lixisenatide was filed for registration in Japan in June 2012 and a
filing with the FDA in the US is expected in December 2012.
Phase III studies of a lixisenatide and Lantus® combination drug based on a pen
device allowing for flexible Lantus® dosing with a fixed lixisenatide dose are
planned for initiation in mid-2013.
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 gastrin and the GLP-1-gastrin dual agonists ZP3022
Gastrin is a naturally-occurring peptide hormone that is released from the
gastrointestinal tract during meal ingestion, stimulating the secretion of
gastric acid and the secretion of digestive enzymes from the pancreas.
Furthermore, it has been suggested that gastrin plays a role in pancreatic
development.
ZP3022 is a compound from Zealand Pharma’s preclinical drug discovery program
on dual acting GLP-1-gastrin peptide agonists, acting on both the GLP-1 and the
gastrin receptors. In preclinical disease models of diabetes (db/db mice and
Zucker Diabetic Fatty (ZDF) rats), ZP3022 has been shown to increase beta cell
mass (insulin producing cell mass) to a greater extent than liraglutide. ZP3022
has also been shown to significantly improve glycemic control in rodents both
during treatment and in a follow up period after treatment stop.
About Diabetes
Diabetes is a long-term disease that occurs either when the pancreas does not
produce enough insulin (the hormone that regulates blood glucose
concentrations), or when the body cannot effectively use the insulin it
produces, or both. This results in raised blood glucose concentrations
(hyperglycemia). Over time, uncontrolled hyperglycemia leads to the
macrovascular and microvascular complications of diabetes. Macrovascular
complications, which affect the large blood vessels, include heart attack,
stroke and peripheral vascular disease. Microvascular complications affect the
small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves
(neuropathy).
The incidence of Type 2 diabetes is growing at an alarming rate. Over 310
million people worldwide is living with the condition today and the number is
expected to increase to more than 550 million people in 2030.
About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company
based in Copenhagen, Denmark. Zealand Pharma specializes in the discovery,
optimization and development of novel peptide drugs and has a broad and mature
pipeline of drug candidates identified through its own drug discovery
activities. The company’s focus lies in the field of diabetes/metabolic
diseases, and its lead drug invention is lixisenatide (Lyxumia®)1, a once-daily
GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2
diabetes. In November 2011, Sanofi filed for registration of lixisenatide in
Europe and regulatory filing in the United States is expected in December 2012.
Zealand Pharma has a partnering strategy for the development and
commercialization of its products and in addition to the collaboration with
Sanofi in Type 2 diabetes, the company has partnerships with Boehringer
Ingelheim in diabetes/obesity, Abbott in acute kidney injury and Helsinn
Healthcare in chemotherapy-induced diarrhea. Zealand Pharma focuses its
activities in 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.