Danegaptide - Cardio-protection (Ischemic reperfusion injury)
-- Earlier in 2013, based on encouraging preclinical results and a substantial
Phase I safety data package, Zealand announced its decision to advance the
clinical development of danegaptide into a Phase IIa Proof-of-Concept
study. Danegaptide is a first-in-class therapeutic approach, and the
objective of the Phase IIa study is to establish further evidence for the
potential for this exciting peptide drug candidate in the prevention of
ischemic reperfusion injury in patients following a heart attack.
-- Preparations are on track for the start of the Phase II study in Q4 2013.
Elsiglutide - Chemotherapy induced diarrhea (partnered with Helsinn)
-- In May, Helsinn decided to advance the development of elsiglutide into
Phase IIb to further evaluate the potential for this GLP-2 peptide agonist
in the prevention of chemotherapy induced diarrhea in colorectal cancer
patients. The decision was based on supportive efficacy findings in a Phase
IIa Proof-of- Concept study as well as Phase I results showing that
elsiglutide is safe and well-tolerated at doses well above expected
-- The start of clinical Phase IIb study activities is expected in Q4 2013.
Commenting on the report, David H. Solomon, President and CEO of Zealand, said:
“The performance over the first half of 2013 signals Zealand’s unique position
and strong outset for continued growth. We have our first peptide drug
invention on the market as an approved diabetes medicine to ensure sustained
royalty revenues going forward, a broad pipeline of peptide drug candidates and
several strong industry partnerships which validate and leverage our expertise
in peptide drug design and development.”
Financial outlook for 2013 retained
Zealand retains expectation of further revenue from Lyxumia® sales royalties in
2013 beyond what has been reported for the first six months period as well as
from potential success based milestone payments from collaboration partners. As
Sanofi has given no guidance on expected sales of Lyxumia®, and with the timing
of potential milestones largely outside Zealand’s control, no more specific
revenue guidance can be provided at this point in time.
Net operating expenses are still expected at a range of DKK 210-240 (EUR 28-32)
million for the full year.
Conference call – H1 2013 Interim report
Zealand will host a conference call today, at 14:30 CET/ 8:30 EST to present
the Interim report for H1 2013, which will be followed by a Q&A session. The
call will be hosted by David Solomon, President and CEO, Mats Blom, CFO and
Hanne Leth Hillman, Vice President, IR and Corporate Communications, and be
conducted in English.
The dial-in numbers to access the call are as follows:
DK: +45 3272 8018
US: +1 866 682 8490
UK and international: +44 (0) 14 5255 5131
Conference ID-number: 34681650
A live audio cast of the call including an accompanying slide presentation will
be available via the following link: