Zealand Pharma A/S - Q1 2011 interim report (un-audited)
5/12/2011 7:27 AM EST
Zealand Pharma A/S
Quarterly report
Zealand Pharma A/S - Q1 2011 interim report (un-audited)
Copenhagen, 2011-05-12 13:27 CEST (GLOBE NEWSWIRE) -- Company Announcement
No. 08/2011
Zealand Pharma A/S - Q1 2011 interim report (un-audited)
-- In the period, further positive Phase III results were announced for
lixisenatide (Type 2 Diabetes), expected to be filed for registration in Europe
in H2 2011
-- Cash and securities of DKK 390.3 (EUR 52.3) million as of 31 March 2011
-- Full year guidance on operating expenses of DKK 170 (EUR 22.8) million
maintained
Copenhagen, 12 May 2011 - Today, Zealand Pharma (ZEAL.CO), a biopharmaceutical
company based in Copenhagen, Denmark, reported pipeline progress and financial
results as expected for the three month period 1 January - 31 March 2011.
In the first quarter of 2011 and the period thereafter, Zealand Pharma has
continued to advance its pipeline of innovative peptide drugs and the overall
development of the business is considered very satisfactory. Most importantly,
further positive study results from the GetGoal Phase III program were
announced with lixisenatide - the company's lead drug candidate for Type 2
Diabetes, for which Phase III development is completing in partnership with
Sanofi. With the latest results, clinical evidence has now been established for
lixisenatide as a new attractive diabetes drug, offering good glycemic control
and weight loss for patients with Type 2 diabetes. Sanofi is progressing the
drug as planned towards expected regulatory filings in Europe in the second
half of 2011.
Furthermore, Zealand Pharma has progressed the development of its two wholly
owned drug candidates; ZP1848 in preparation for Phase IIa as a novel treatment
of Inflammatory Bowel Diseases and ZP2929, the company's 2nd generation GLP-1
drug candidate ready for Phase 1 for the treatment of diabetes and obesity.
As a consequence of increased development costs to rapidly advance the value of
the Zealand Pharma drug pipeline, the company's total operating expenses for
the first quarter of 2011 amounted to DKK 45.2 (EUR 6.1) million compared to
DKK 25.6 (EUR 3.4) million for the same period in 2010. The expenses are as
expected and in line with the company's full year guidance for 2011. Net
results for the first quarter were a loss before tax of DKK 44.9 (EUR 6.0)
million (Q1 2010: DKK 23.1 (EUR 3.1) million).
The company's cash and securities amounted to DKK 390.3 (EUR 52.3) million as
of 31 March 2011.
Highlights from Q1 2011 and the period thereafter
Pipeline achievements
-- Lixisenatide (completing Phase III for Type 2 diabetes)
-- In February (Company announcement 01/2011) , top-line results from the
GETGOAL-X Phase III study (639 patients) showed that once-daily
lixisenatide achieved the primary endpoint of non-inferiority in HbA1c
reduction from baseline, compared with twice-daily exenatide (trademark
Byetta®).
-- In April (Company announcement 05/2011), top-line results from the
GETGOAL-S study (859 patients), showed that lixisenatide significantly
reduced HbA1c levels versus placebo in diabetes patients, in-adequately
controlled on sulfonylureas, with a significantly positive effect seen
on both 2-hour post-prandial glucose and fasting plasma glucose levels.
Further, patient treated with lixisenatide had a significant decrease in
body weight, versus those receiving placebo.
-- Danegaptide (completed Phase Ib for the treatment of cardiovascular
diseases)
-- Zealand Pharma and Pfizer have signed an agreement resulting in the
return to Zealand Pharma of all rights to danegaptide, a potential novel
treatment for cardiovascular diseases. This completes the return to
Zealand Pharma of all rights to and all clinical data generated with
this compound, as announced in Zealand Pharma's IPO prospectus and in
the 2010 report.
-- Granted EU award of EUR 0.9 (DKK 6.4) million in collaboration with Pepscan
for a top-ranked project to jointly develop novel peptide drugs to treat
chronic inflammations and other gastro-intestinal diseases.
Other events
-- At the Annual General Meeting on 28 April, Jutta af Rosenborg and Jørgen
Lindegaard, two experienced Danish business executives, joined as new board
members.
David H. Solomon, President and CEO of Zealand Pharma commented on the report:
“I am very pleased to report that in 2011, Zealand Pharma has continued to
deliver as expected following the IPO in November last year. Most importantly
four out of nine Phase III studies have now shown positive results for
lixisenatide, our lead product for the treatment of Type 2 diabetes, and the
clinical support for lixisenatide as a potential novel and attractive diabetes
drug is mounting. We look forward to sharing the remaining Phase III results
with our stake holders and await the expected regulatory filings by Sanofi of
lixisenatide in Europe in the second half of 2011 - as a decisive step towards
our first product coming to the market to benefit diabetes patients.”
“Also, our internal pipeline programs have been advanced and we are
particularly excited about the prospects of bringing our second generation
GLP-1 candidate, ZP2929 into the first clinical studies expectedly in the third
quarter of 2011 for the treatment of patients with diabetes and obesity.”
Financial outlook for 2011
Zealand Pharma maintains its financial guidance for the full year of total
operating expenses of approximately DKK 170 (EUR 22.8) million.
No guidance is provided on revenue, since most of Zealand Pharma's revenue
stems from milestone payments from partners, the timing of which is largely
outside the control of the company.
- # -
Conference call
Zealand Pharma will host a conference call today, Thursday, May 12 at 14:00
CET. David H. Solomon, President & Chief Executive Officer, Mats Blom, Chief
Financial Officer and Hanne Leth Hillman, Vice President for IR and Corporate
Communications will host the call and present the Q1 results followed by a Q&A
session. The conference call will be conducted in English and the dial-in
numbers are:
DK +45 32 72 76 25
UK and international +44 (0) 145 255 5566
US +1 866 966 9439
Pass code for all participants: 6466 8706
An accompanying slide presentation will be available for download from the
company's website (ir.zealandpharma.com) approximately half an hour before the
event.
For further information, please contact:
Zealand Pharma A/S
David H. Solomon, President and Chief Executive Officer
Tel: +45 4328 1200
Hanne Leth Hillman, Vice President for IR & Corporate Communications
Tel: +45 8877 3689 or Mobile: +45 5060 3689
Forward-looking statements
This announcement includes “forward-looking statements” that involve risk,
uncertainties and other factors, many
of which are outside of our control that could cause actual results to differ
materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives,
goals, future events, performance and/or other information that is not
historical information. We undertake no
obligation to publicly update or revise forward-looking statements to reflect
subsequent events or circumstances
after the date made, except as required by law.
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 drugs. The company's lead product candidate is a once-daily
GLP-1 in late-stage Phase III development for the treatment of Type 2 Diabetes
in collaboration with Sanofi. Zealand Pharma also has other collaboration and
licensing partnerships, including a license agreement with Helsinn Healthcare
on a clinical stage GLP-2 drug for the treatment of Chemotherapy and
Radiotherapy Induced Diarrhoea.
Zealand Pharma has unique expertise in peptide discovery and optimization and
in the development of novel peptide drugs with favourable therapeutic
attributes. The company targets metabolic (diabetes and obesity),
gastrointestinal and cardiovascular diseases, 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. All of Zealand Pharma's
product candidates have been identified through the company's own drug
discovery activities. The company has approximately 90 employees. For more
information please visit www.zealandpharma.com.