Zealand Pharma

Regulatory Filings • Dec 6, 2011

News Details

Ad-hoc | 6 December 2011 07:03

Positive results reported by Sanofi for once-daily lixisenatide (Lyxumia(r) 1)) in combination with Lantus(r) (insulin glargine) in Type 2 diabetes

Zealand Pharma A/S

06.12.2011 07:03

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-- Data from a Phase III study, GetGoal Duo 1, show that lixisenatide in
combination with Lantus(r) helps achieve HbA1c <7.0% in Type 2 diabetes and
significantly improves 2-hour post-prandial glucose in uncontrolled patients

Copenhagen, 6 December 2011 - Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL)
announces that its partner Sanofi has reported positive top-line results from a
Phase III study, GetGoal Duo 1, evaluating the efficacy and safety of
lixisenatide (Lyxumia(r)) in combination with Lantus(r) (insulin glargine),
Sanofi's world leading basal insulin product, for the treatment of patients
with Type 2 diabetes uncontrolled on oral anti-diabetic (OAD) treatment -
mainly metformin. Lixisenatide is an investigational once-daily GLP-1 peptide
agonist discovered by Zealand Pharma and licensed to Sanofi.

In GetGoal Duo 1, lixisenatide in combination with insulin glargine achieved
the primary study endpoint of significantly reducing HbA1c with a significant
improvement in 2-hour post-prandial glucose levels compared to insulin
treatment alone in patients with Type 2 diabetes.

Commenting on today's announcement, David Solomon, Chief Executive Officer and
President of Zealand Pharma, said: 'We are very excited about the continuous
flow of strong results from the GetGoal studies, supporting the unique clinical
profile of lixisenatide. The positive outcome of the GetGoal Duo 1 study
provides additional important evidence for the use of lixisenatide in
combination with Lantus(r) for the treatment of Type 2 diabetes. Lantus(r) is the
No.1 leading basal insulin product in the world, and the results from GetGoal
Duo 1 show that adding lixisenatide to treatment with Lantus(r) can offer
significant benefits to patients.'

'Lixisenatide is a promising new GLP-1 agonist with a mode of action which
complements that of basal insulin. Added once-daily to optimally titrated
Lantus(r), it safely improved HbA1c with beneficial effects on both post-prandial
glucose and body weight,' commented Dr Matthew Riddle, Professor of Medicine
and Head of the Diabetes Division at the Oregon Health and Science University,
Portland, U.S.

''This is another key milestone in the clinical development program for our new
GLP-1 agonist,' declared Pierre Chancel, Senior Vice-President of Sanofi
Diabetes. 'Achieving glycemic control and compliance with treatment is a
complex challenge. These positive results show that once-daily lixisenatide in
combination with Lantus(r) could be an innovative therapeutic option for the
treatment of uncontrolled Type 2 diabetes by addressing its pathophysiology
especially regarding post-prandial glucose control with a convenient once-daily
regimen, helping those patients who fail to meet HbA1c target despite
controlled fasting plasma glucose.'

The Phase III GetGoal Duo 1 study was a 24-week randomized, double-blind,
placebo-controlled study in patients with Type 2 diabetes uncontrolled on oral
anti-diabetic (OAD) treatment - mainly metformin. In a 12-week run-in period to
the study, patients were initiated on insulin glargine and titrated to reach a
target fasting plasma glucose of 80-100 mg/dL. After 12 weeks, 446 patients
with HbA1c >7% - despite controlled fasting plasma glucose, were randomized to
receive either lixisenatide once-daily or placebo while insulin glargine and
metformin were continued.

During the run-in period, patients' HbA1c decreased on average from 8.60% to
7.60%. In the study period thereafter, patients randomized to treatment with
lixisenatide in addition to Lantus(r) had a significantly greater further HbA1c
decrease compared with the placebo group (p<0.0001) after 24 weeks to a mean
value of 6.96%. A significantly higher percentage of patients in the
lixisenatide arm achieved target HbA1c <7.0% compared to the placebo group
(56.3% versus 38.5%, p=0.0001).

Lixisenatide also significantly improved 2-hour post-prandial glucose with a
mean difference of -3.16 mmol/L (p<0.0001) vs placebo. The mean difference in
body weight change between the lixisenatide and placebo groups was -0.89 kg
(p=0.0012).

Consistent with the GLP-1 class, the most common adverse events were mild and
transient nausea and vomiting. Fifty lixisenatide-treated patients (22.4%) and
30 patients (13.5%) in the placebo group reported symptomatic hypoglycemic
events as defined in the protocol during the on-treatment period. 88% of
patients in the lixisenatide arm reached and remained on the 20 mug maintenance
dose.

On 16 November 2011, the European Medicines Agency (EMA) accepted Sanofi's
marketing authorization application for lixisenatide (Lyxumia(r)) as submitted by
Sanofi at the end of October. Submission for regulatory approval of
lixisenatide in the United States is expected in Q4 2012.

The full study results from GetGoal Duo 1 are planned to be presented at a
future medical congress.

1) Lyxumia(r) is the intended trademark of lixisenatide.

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
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 the GetGoal Duo 1 showing the effect and safety of lixisenatide
(Lyxumia(r)) as add-on treatment to Lantus(r) 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.

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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, hlh@zealandpharma.com

About lixisenatide (Lyxumia(r))

Lixisenatide, a once-daily glucagon-like peptide-1 agonist (GLP-1), 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,
the American Diabetes Association, 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, and GetGoal-F1 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 (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 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 October 2011, Sanofi
filed for marketing authorisation for lixisenatide (Lyxumia(r)) in Europe.
Submission for regulatory approval of lixisenatide in the United States is
planned for 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 of lixisenatide.

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Language: English
Company: Zealand Pharma A/S

          Dänemark

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ISIN: DK0060257814
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